- Email: [email protected]
New female condoms in the pipeline
ISSUES IN CURRENT SERVICE DELIVERY
New female condoms in the pipeline Mags Beksinska,a Jennifer Smit,b Carol Joanis,c William Potterd a Technical Advisor, Maternal, Adolescent and Child Health (MatCH), Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Correspondence: [email protected] b Deputy Divisional Head, MatCH, Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa c President, Joanis Consulting, Kennesaw, GA, USA d Director, Stapleford Scientific Services, Cambridge UK
Abstract: Male and female condoms are currently the only effective dual protection methods against unintended pregnancy and transmission of STIs and HIV. In recent years, advocacy and support to female condom (FC) programmes and increased distribution have played a significant role in highlighting to donors, policy-makers and programme managers the importance of FCs as essential tools for dual prevention. Further, the emergence of new FC products, differing in design and materials, has the potential to lower cost and improve acceptability. There are hurdles in developing new FC products, by far the greatest being the clinical studies required for regulatory purposes. However, several new designs are now available in selected countries and some are progressing through the final stages of regulatory approval, after which they will be more widely available. The new FC designs, which may also be more affordable, will increase options and choice for couples who want to use FCs as their prevention method. Here, we review the FC products that are available now and those still in development which are expected to be available within the next two to five years. © 2012 Reproductive Health Matters Keywords: female condoms, regulatory processes, dual protection, acceptability, choice Although female condoms (FCs) have been promoted for many years as a woman-initiated, dual protection method for pregnancy and STI/HIV prevention, they have been neglected as a significant player in the field.1 Lack of commitment by major donors to support FC programming has meant they have not been an accessible prevention option in many of the countries hardest hit by HIV. A comprehensive analysis of why the FC has not reached its full potential is attributed to a lack of acceptability in the international policy arena, which has led to a reticence to support its introduction, rather than its acceptability among users.2 Conversely, development of new prevention approaches such as microbicides, medical male circumcision, pre-exposure prophylaxis (PrEP) and vaccines continue to be well-funded despite setbacks and/or research results showing marginal effectiveness. The FC has recently been identified by the Reproductive Health Supplies Coalition as one of several under-used reproductive health tech-
nologies. The Coalition aims to improve choice of these technologies and contribute to country level efforts towards achieving universal access to services and products. A product brief has been developed for each of the under-used technologies which gives information on efficacy, current programme use, manufacturing and registration status of new products, and public sector price agreements.3 In recent years, a number of initiatives have re-energised the female condom landscape. The UN Population Fund (UNFPA) Intensified Global Initiative provides support to 23 countries across the world to implement FC programmes.4 Launched in 2005, this initiative aims to scale up access to FCs through financial and technical support to country programmes. Several participating countries have reintroduced the FC through this initiative, having learned from past mistakes the need to ensure that programming efforts are sustainable. The Universal Access to Female Condoms Joint Programme (UAFC) is also supporting several
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Doi: 10.1016/S0968-8080(12)40659-0
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African countries through the provision of FCs and educational programmes targeting men, youth and women at risk.4,5 Programming support is critical as it has been documented that funding for the product itself, without investment in effective and comprehensive programming, can lead to stock-outs, lack of access and limited availability.1 Analysis of five female condom programmes with high volume distribution found that successful programmes were effective at identifying target populations and ensuring those populations were able to access the method through appropriate channels.6 Female condom distribution world-wide has increased notably; between 2007 and 2010, it doubled from 25 to 50 million units.7 Compared to male condoms, however, based on data compiled by the Reproductive Health Supplies Coalition, FC purchases account for only 0.19% of global condom procurement.3 In South Africa, one of the countries with a well-established FC programme, FC distribution increased to 5.1 million units in 2010; however, male condom distribution increased to 2.5 billion.8 Donor commitment also reflects this imbalance, with FCs representing only 3.2% of total US government donated condoms in 2009.1 Although FC distribution rates lag far behind those of male condoms, there has been significant progress in FC technology. Since 2000, new FC products have become available or are in development, with the aims of reducing unit cost and improving acceptability, with some donor support. One of these is the Woman’s Condom, developed by PATH (Programme for Appropriate Technology in Health), which aims to develop innovative high-impact, low-cost prevention solutions. UAFC has also supported several new FCs in various stages of their development and manufacturing. In other cases, new FCs have been developed by manufacturers of male condoms seeking to diversify their portfolios or with an interest in increasing prevention options. There are recognized challenges in developing new FC products. By far the greatest hurdle are the clinical studies required for regulatory purposes. In the US, FCs are classified as Class III devices by the United States Food and Drug Administration (USFDA), unlike male condoms, which are designated as Class II medical devices. Class III status was applied to FCs for safety reasons by USFDA as there was no history of FC contraceptive effectiveness. In Europe, FCs have the same classification as male condoms (Class IIb)
and the regulatory process is therefore simpler and quicker. Because the new FCs are considered a new type of medical device most regulatory agencies require evidence from clinical trials to confirm that the products provide levels of protection against STIs and pregnancy that are at least equivalent to those for male condoms. Depending upon the design of the device and the specific regulatory agency concerned, this evidence can range from studies demonstrating non-inferiority with respect to a male condom in terms of failure rates (e.g. breakage and slippage) through to contraceptive efficacy rates. This is important to note, since the existing market for FCs is almost entirely donor driven with a very limited demand in the private sector. Donors purchasing FCs as part of international aid programmes normally require the products to be pre-qualified by UNFPA. Some US-based procurement agencies may require USFDA marketing authorization, which in turn may be dependent on the satisfactory outcome of contraceptive efficacy studies. Manufacturers wishing to develop and market FCs need to target the donor market, yet to do so requires considerable investment in testing and clinical trials, which are prohibitively costly and take years to complete. Emerging FC manufacturers urgently need more guidance to enable them to undertake all the required testing and compile the required documentation needed for regulatory approval. Without regulatory approval many FC manufacturers cannot enter the market or be considered for procurement by donor agencies. The International Organization for Standards (ISO) has developed clear standards for male condoms with guidance on specifications and test methods used to verify the quality of male condoms. The international standard for female condoms, ISO 25841, was published in 2011 and had not previously been available to manufacturers. For most of the newer designs of FC this has meant that the effectiveness and safety of each product has had to be evaluated by experts on a product-by-product basis. The WHO Department of Reproductive Health and Research (WHO RHR) established a Female Condom Technical Review Committee in 2006. This expert group was convened to evaluate FC manufacturer’s dossiers in order to make recommendations for bulk procurement of FCs that met all required specifications. The WHO/UNFPA Generic Female Condom Specification is now close to finalization and should 189
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be available on the UNFPA website before the end of 2012. The specification forms the basis of the UNFPA pre-qualification scheme for FCs and covers the following key areas:
• • • •
General requirements specify the clinical performance requirements. Performance requirements specify the essential performance attributes. Design requirements are mainly concerned with acceptability to the end user. Packaging requirements that purchasers may specify, with particular requirements depending upon the target population.
Female condoms available now or in development Although the different FCs available now or in development often have unique design features, there are many similarities between them with respect to function. The following are common components of a female condom:
• • • •
a sheath that lines the vagina and may extend to cover, or partially cover, the external genitalia; an external anchor retention feature that prevents the condom from being pushed into the vagina, commonly a ring or frame which also serves as a removal mechanism; an internal retention feature to keep the condom within the vagina, e.g. a ring or foam sponge;* a product insertion feature that facilitates insertion into the vagina; the internal retention feature may also serve this function.
The FC products described below are either available now or are expected to be available within the next two to five years. This list is comprehensive; it has been compiled from a range of sources, including various meetings and committees involving UNFPA, WHO and a range of condom manufacturers. The detailed specifications for each product are listed in Figures 1–8 with a visual of each device, along with attributes such as design, materials and lubricants, and information about the manufacturers. The FC2â The FC2 replaced the polyurethane FC1, which had been available since 1993. It became avail*Some studies of FCs in development are investigating stability without the use of an internal mechanism.
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able in some countries in 2005. The FC2 is similar in specification, function and appearance to the FC1, but is made of synthetic nitrile rubber latex (Figure 1). The manufacture of FC1 ceased in 2009; however, it has a five-year shelf-life and existing supplies may still be used until 2014. FC2 is manufactured by a dipping process on high volume, automated production lines. This process change, in conjunction with the conversion to a nitrile material, resulted in a decrease in cost of approximately 25% as compared to the FC1. The performance and acceptability of FC2 is comparable to FC1.9,10 In these studies, no difference was found in failure rates for breakage, slippage or invagination. Following completion of the technical review process by WHO, FC2 was found acceptable for bulk procurement by all UN agencies in 2007. In 2009, it was approved by US FDA. As the FC1 was the first FC to enter the market, there is a body of research published on its contraceptive efficacy,11–13 acceptability,14 function,9,15,16 and prevention of sexually transmitted infections (STI).17 There are no data available on the contraceptive efficacy or STI prevention capability of the FC2. Since FC1 and FC2 are similar in design and specification, approval of FC2 was granted by US FDA on the basis of the results of a comparative, noninferiority clinical trial of device function.9 The Woman’s Condom The Woman’s Condom is made of polyurethane and is inserted using a dissolving capsule. The sheath of the condom is enclosed in a capsule which dissolves after insertion (Figure 2) releasing the condom within the vagina. The dissolving capsule is made of polyvinyl alcohol, the same material used to make vaginal contraceptive film (C-film). The four foam shapes on the body of the condom cling lightly to the vaginal wall to ensure stability. The condom is not pre-lubricated. It comes with a sachet of water-based lubricant that is applied by the user. Acceptability trials have shown it is acceptable to users.18,19 The performance has also been found to be similar to FC2.20 A pregnancy effectiveness study is near completion in the United states. Results are expected in 2013. In 2008, PATH licensed the Dahua Medical Apparatus Co., Shanghai, China, to manufacture and distribute the Woman’s Condom. The Phoenurse The Phoenurse FC is made of polyurethane and pre-lubricated with a silicone lubricant. The body
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of the condom is slightly longer than the FC2 and is dumbbell-shaped. Phoenurse is marketed with an insertion device which attaches to the inner ring and can be used to insert the condom into the vagina (Figure 3). The inner ring can also be used for insertion in a similar way to FC2. The Phoenurse FC is approved for use in China but not sold outside the country at this writing. A recent trial in China found that it is acceptable to women, and its functional performance in terms of failures such as breakage and slippage is similar to FC1.21 A further clinical trial to assess functional performance and acceptability of the Phoenurse compared to FC2 will commence in 2013. The Cupidâ and Cupid2 The Cupid â FC (Figure 4) is inserted using a medical grade, non-biodegradable sponge which can be compressed between the fingers and used to push the condom into the vagina. The sponge 192
also holds the condom in place during use and acts in a similar way to the inner ring in other female condoms, for insertion and stability. The Cupid comes in both natural and pink colours and is the only FC that is vanilla scented. This FC was prequalified in June 2012 for bulk procurement by UNFPA following recommendations from the WHO/UNFPA Female Condom Technical Review Committee. It is the second condom that can now be procured globally for the public sector donor market. It is already available in India, Brazil, Indonesia, Netherlands and South Africa and has recently been launched in Mozambique by PSI under the name Jeitosa. (www.condoms4all. org, 17 July 2012) The Cupid2 is identical to the Cupid â but is slightly shorter with a smaller sponge. The manufacturer has developed this FC for the Asian market where smaller male condoms are also commonly used. However, this condom is still being tested,
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and clinical trials to ensure it functions adequately are due to commence in 2013. If made available in future, this will give women an option to use an FC with a smaller fit. The Panty (Condon Femenino) The Panty (Condon Femenino) has a distinct design compared to other FCs (Figure 5). The panty holds the condom in place during intercourse and has the same function as the outer ring or frame of other FCs. This FC cannot be used without the panty. The nylon panty itself is reusable. A new condom sheath must be inserted and secured into the panty each time and removed after one use. The panty can then be washed and a new condom can be fitted The Panty FC does not have an insertion device like a ring or a sponge. Instead, once the panty is on, the condom sheath is pushed into the vagina using a finger or the penis. Panty FCs are more expensive than the other FCs described here and are generally less available. The product can be purchased as a single panty and condom or a panty with a packet of 3 condoms. This FC is under review by the WHO/UNFPA Female Condom Technical Review Committee, and clinical work on function and acceptability is due to be undertaken in 2013. The HLL The HLL FC, named after the manufacturer as it is too new to have a name, is similar in design and appearance to the FC2, with an inner and outer circular ring (Figure 6) but made of natural rubber latex. This FC has only been in development since 2011 and is at this writing in process of undergoing the required testing. A clinical trial to evaluate its function will commence in 2013. The Origamiä ä The Origamiä is also currently in development (Figure 7). This FC is made of silicone that has been formulated specifically to provide high elongation and durability during vaginal intercourse. The product is folded “origami style” and inserted by pushing the folded material into the vagina. The design is intended to minimize its size for ease of insertion. After insertion, the condom will deploy to its full length during intercourse. The silicone formulation of the material was chosen for its robustness and potential to be a viable, re-usable condom. The possibility of re-use, if found to be feasible, has great potential for low-
ering the cost. Phase I testing as a re-usable device will commence in the US in 2014. The VA w.o.wâ (Condom Feminine) The VA w.o.w â (worn of women), Condom Feminine encases a medical-grade, non-biodegradable sponge at the closed end of the device, similar to the Cupid. The sponge is used for insertion, and the condom is the shortest of all the FCs (Figure 8). In studies conducted in India and South Africa, this condom was found to be acceptable to users.20,22 Currently, manufacture of the product is suspended, possibly related to change of ownership of the factory.
Discussion New female condom designs will increase the options for couples who choose to use them as their prevention method. Some designs are also expected to reduce cost, in particular those made of natural rubber latex (the same material as male condoms), bringing them closer to the unit price of male condoms. Specific FC purchase prices vary considerably, however, and within the main donor-funded public sector market, individual negotiations and volume purchased will affect unit price. However, the estimate for the FC2 in 2012 was US$0.57/unit with potential lower cost, depending on volume.3 The approval of Cupidâ in 2012 is an important step forward, with an estimated price of US$0.35 per unit for 2012.7 This will encourage competition to lower costs for countries and increase choice. Although good evidence for the effect of choice of method on increased uptake of contraceptive methods is limited, a systematic review of the evidence in 2006 supported the contention that increased choice for women is associated with increased uptake and with better health outcomes (such as lower pregnancy rates and fewer STIs). Further, women given a choice exercise it and continue use of their chosen contraceptives to a greater degree than those denied a choice of method.23,24 A study in which women had the opportunity to use the FC2, the Woman’s Condom and the VA w.o.w and then choose which one they preferred found that all three were acceptable, with the design of the Woman’s Condom the most liked. Almost all participants expressed a preference for one of the three by the end of the study.20 As more FCs become available, careful planning will be needed within programmes. Each female condom requires product-specific training, 193
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instruction and informational materials and programme planners must be aware of this to ensure correct use, particularly in programmes supplying a number of products.25 Once women are used to these products, however, the need for such detailed instruction will be reduced.26 Renewed interest in female condoms, the emergence of a variety of new designs, and initiatives to facilitate their journey through the regulatory process are all promising. Raising the profile of FCs through a wider range of products may also increase awareness that the WHO Essential Medicines list currently includes “condoms” but does not specify male and female condoms.27 For countries adopting this list, female condoms may not be assumed to be part of the “condoms” category. This presents a significant barrier to female condom procurement for countries, but ongoing discussions have not yet led to this being rectified. Other challenges also remain, including the requirement to conduct more pregnancy and STI/HIV prevention effectiveness studies with the new designs, thus providing more evidence for donors, programme managers and users. The body of evidence available for both pregnancy and STI/HIV prevention effectiveness is exclusively for FC1, now discontinued. However, these studies are expensive and donors are reluctant to support them. Recent advances in the detection of biomarkers of semen in the vagina are important, in that they could help evaluate the safety of barrier methods such as female condoms and diaphragms.28 Prostate-specific antigen (PSA) is one of these biomarkers and research is ongoing to validate PSA data in pregnancy efficacy and STI trials. Recommendations have been made to the USFDA to accept evidence that the presence of PSA in the vagina can be used to detect female condom failures.29 The possibility of re-use of female condoms was once proposed as a way to reduce their high cost relative to male condoms, and research was done to investigate the robustness of the FC1 in this regard.30 WHO refused to endorse re-use, however, and the impetus was lost.31 FC1 was made of polyurethane, a far stronger material than synthetic and natural rubber latex. With FC1 no longer available and many new female condoms made of natural rubber latex, re-use is not feasible, as the condoms would deteriorate with even one washing. In the future, some female condoms may have the potential for re-use, but this will be entirely dependent on their design and the 194
material they are made of, and would require regulatory approval for this indication, as well as specific instructions for re-use. There are initiatives from UNFPA and the WHO Department of Reproductive Health and Research that have provided support to emerging FC manufacturers. Two workshops have been held to date which have taken manufacturers through all the steps of the development and regulatory processes. The existing manufacturers are all private companies, who will only consider moving into female condom development and manufacture if they can foresee some profit from it. However, several of the manufacturers are also committed to improving protection options for women and are moving into the field despite the expense and lengthy testing and regulatory processes. The female condom is unique in that it can be inserted by the woman, either just before or well before sex, and insertion is not reliant on the partner. It is currently also the only dual protection alternative to the male condom. The potential for the method to help to empower women through increased opportunities to discuss and negotiate safer sex needs to be capitalized on further.32
Paper Doll campaign
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A number of global initiatives to promote FCs have recently been launched, signifying a renewed interest in female condoms. In 2009, the Universal Access to Female Condoms Joint Programme initiated an international advocacy platform to broaden and strengthen the international support base for FCs. This platform (www.condoms4all. org/) has made considerable progress in raising awareness and demand for FCs, including the “Paper Doll Campaign”, which ran up to and during the International AIDS Conference in Washington DC in July 2012. Thousands of people wrote messages on the paper dolls asking for more choice, lower prices, and improved access to female condoms. This culminated in the display of thousands of the dolls on the last day
of the Conference. The first Global Female Condom Day (www.nationalfccoalition.org/) was held on 12 September 2012, and many organisations marked the event. The pre-qualification by UNFPA of the FC2 for the global donor market, with several more on the horizon, coupled with the potential for lower prices and renewed efforts to increase demand, are strong indications that female condoms are finally being taken more seriously as a viable method of both pregnancy and STI/HIV prevention. Acknowledgements We would like to acknowledge the William and Flora Hewlett Foundation for support to authors Beksinska and Smit.
References 1. Center for Health and Gender Equity. Female condoms and US foreign assistance: an unfinished imperative for women’s health. Washington, DC, 2011. 2. Peters A, Jansen W, van Driel F. The female condom: the international denial of a strong potential. Reproductive Health Matters 2010;18(35):119–28. 3. Reproductive Health Supplies Coalition. Caucus on new and underused reproductive health technologies. Product brief: female condom. www.rhsupplies.org/workinggroups/caucus-on-newunderused-rh-technologies.html. 4. www.unfpa.org/hiv/female.htm#global. 5. www.condoms4all.org. 6. Peterson K, Herman L, Fiske L, et al. Smarter programming of the female condom: increasing its impact on HIV prevention in the developing world. www.fsg.org/ tabid/191/ArticleId/60/Default.aspx?srpush=true. 2008. 7. UNFPA. HIV prevention gains momentum: UNFPA; 2011. 8. UNAIDS. Country Progress Report on the Declaration of Commitment on HIV/AIDS. Final Report, Republic of South Africa, 2010. www.unaids.org/en/dataanalysis/ monitoringcountryprogress/2010progressreportsubmitted bycountries/southafrica_2010_country_progress_ report_en.pdf. 9. Beksinska M, Smit J, Mabude Z, et al. Performance of the Reality polyurethane female condom and a synthetic latex prototype: a randomized cross-over trial among South African women. Contraception 2006;73:386–93. 10. Smit J, Beksinska ME, Mabude Z, et al. Acceptability of the Reality polyurethane female condom and a synthetic latex prototype: A randomized cross-over trial among South African women. Contraception 2006;73:394–98. 11. Bounds W, Guillebaud J, Newman GB. Female condom (Femidon). A clinical study of its use-effectiveness and
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patient acceptability. British Journal of Family Planning 1992;18:36–41. Farr G, Galbenick H, Sturgen K, et al. Contraceptive efficacy and acceptability of the female condom. American Journal of Public Health 1994;84:1960–64. Trussell J. Contraceptive efficacy of the Reality female condom. Contraception 1998;58:147–48. World Health Organization. The female condom: a review. Geneva: WHO; 1997. Valappil T, Kelaghan J, Macaluso M, et al. Female and male condom failure among women at high risk of sexually transmitted disease. Sexually Transmitted Diseases 2005;32(1):35–43. Leeper MA, Conrady M. Preliminary evaluation of REALITY, a condom for women to wear. Advances in Contraception 1989;5:229–35. Vijayakumar G, Mabude Z, Smit J, et al. A review of female-condom effectiveness: patterns of use and impact on protected sex acts and STI incidence. International Journal of STDs & AIDS 2006;17:652–59. Coffey PS, Kilbourne-Brook M, Austin G. Short-term acceptability of the PATH Woman’s Condom among couples at three sites. Contraception 2006;73:588–93. Schwartz JL, Barnhart K, Creinin MD, et al. Comparative crossover study of the PATH Woman’s Condom and the FC Female Condomâ. Contraception 2008;78: 465–73. Joanis C, Beksinska M, Hart C, et al. Three new female condoms: which do women prefer? Contraception 2011;83:248–54. Hou LY, Qiu HY, Zhao YZ, et al. A crossover comparison of two types of female condom. International Journal of Gynecology & Obstetrics 2010;108:214–18.
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M Beksinska et al. Reproductive Health Matters 2012;20(40):188–196 22. Smita J, Neelam J, Rochelle DY, et al. Comparative acceptability study of the Reality female condom and version 4 of modified Reddy female condom in India. Contraception 2005;72:366–71. 23. Systematic Review of Contraceptive Medicines. “Does choice make a difference?” October 2006. http://archives.who.int/eml/expcom/expcom15/ applications/sections/ContraChoiceReview.pdf. 24. Jain AK. Fertility reduction and the quality of family planning services. Studies in Family Planning 1989;20:1–16. 25. MatCH. Developing a Strategy for female condom parallel programming: proceedings of an expert meeting. Durban, 23–24 November 2011. www.match.org.za/ news/Pages?StrategyforFemaleCondom.aspx. 26. Beksinska M, Smit, Joanis C, et al. Practice makes perfect: Reduction in female condom failures and user problems with short-term experience in a randomized trial. Contraception 2012;86:127–31. 27. World Health Organization. WHO Model List of Essential Medicines, 17th list. Geneva: WHO, 2011.
Résumé Les préservatifs masculins et féminins sont actuellement les seules méthodes efficaces de double protection contre les grossesses non désirées et la transmission des IST et du VIH. Ces dernières années, le plaidoyer et le soutien aux programmes de préservatif féminin et la distribution accrue de ces produits ont joué un rôle important pour insister auprès des donateurs, des décideurs et des responsables de programmes sur l’importance du préservatif féminin comme outil essentiel de la double prévention. De plus, l’apparition de nouveaux produits, différents en conception et matériel, peut en diminuer le coût et améliorer l’acceptabilité. La conception de nouveaux préservatifs féminins rencontre des écueils, le principal étant les études cliniques nécessaires à des fins régulatrices. Néanmoins, plusieurs nouveaux produits sont maintenant disponibles dans des pays sélectionnés et d’autres se rapprochent du stade final de l’agrément, après quoi ils deviendront largement disponibles. Ces nouveaux produits, qui seront peut-être aussi plus abordables, multiplieront les options et les choix pour les couples qui veulent utiliser le préservatif féminin comme méthode de prévention. Nous étudions ici les préservatifs féminins disponibles et ceux qui sont en cours d’élaboration et devraient être commercialisés d’ici deux à cinq ans.
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31.
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www.who.int/medicines/publications/essentialmedicines/ en/index.html. Mauck CK, Doncel GF, and Biomarkers of Semen Exposure Clinical Working Group. Biomarkers of semen in the vagina: applications in clinical trials of contraception and prevention of sexually transmitted pathogens including HIV. Contraception 2007;75:407–19. Mauck CK, Weaver MA, Schartz JL, et al. Critical next steps for female condom research: report from a workshop. Contraception 2009;79:339–44. Beksinska ME, Rees VH, Dickson-Tetteh KE, et al. Structural integrity of the female condom after multiple uses, washing, drying and re-lubrication. Contraception 2001;63(1):33–36. World Health Organization. Considerations Regarding Re-use of the Female Condom: Information Update, 10 July 2002. In: Reproductive Health Matters 2002;10(20):182–86. Gollub EL. The female condom: tool for women’s empowerment. American Journal of Public Health 2000;90(9):1377–81.
Resumen Actualmente, los condones masculinos y femeninos son los únicos métodos eficaces de doble protección contra el embarazo no intencional y la transmisión de ITS y VIH. En los últimos años, la promoción y defensa de programas de condón femenino (CF) y mayor distribución han desempeñado un papel decisivo en recalcar a donantes, formuladores de políticas y gerentes de programas la importancia de los CF como herramientas esenciales para la doble prevención. Más aún, la emergencia de nuevos productos de CF, que difieren en diseño y materiales, tiene el potencial de reducir el costo y mejorar su aceptación. Existen obstáculos para crear nuevos productos de CF; el mayor es los estudios clínicos exigidos para fines normativos. Sin embargo, en algunos países ahora hay varios diseños disponibles y algunos están progresando hacia las etapas finales de la aprobación reglamentaria, tras la cual estarán disponibles de manera más extendida. Los nuevos diseños de CF, que posiblemente sean menos costosos, ampliarán las opciones de parejas que desean usar CF como método de prevención. Aquí se revisan los productos de CF actualmente disponibles y aquellos aún en desarrollo, que se espera estén disponibles en los próximos dos a cinco años.
New female condoms in the pipeline Mags Beksinska,a Jennifer Smit,b Carol Joanis,c William Potterd a Technical Advisor, Maternal, Adolescent and Child Health (MatCH), Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Correspondence: [email protected] b Deputy Divisional Head, MatCH, Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa c President, Joanis Consulting, Kennesaw, GA, USA d Director, Stapleford Scientific Services, Cambridge UK
Abstract: Male and female condoms are currently the only effective dual protection methods against unintended pregnancy and transmission of STIs and HIV. In recent years, advocacy and support to female condom (FC) programmes and increased distribution have played a significant role in highlighting to donors, policy-makers and programme managers the importance of FCs as essential tools for dual prevention. Further, the emergence of new FC products, differing in design and materials, has the potential to lower cost and improve acceptability. There are hurdles in developing new FC products, by far the greatest being the clinical studies required for regulatory purposes. However, several new designs are now available in selected countries and some are progressing through the final stages of regulatory approval, after which they will be more widely available. The new FC designs, which may also be more affordable, will increase options and choice for couples who want to use FCs as their prevention method. Here, we review the FC products that are available now and those still in development which are expected to be available within the next two to five years. © 2012 Reproductive Health Matters Keywords: female condoms, regulatory processes, dual protection, acceptability, choice Although female condoms (FCs) have been promoted for many years as a woman-initiated, dual protection method for pregnancy and STI/HIV prevention, they have been neglected as a significant player in the field.1 Lack of commitment by major donors to support FC programming has meant they have not been an accessible prevention option in many of the countries hardest hit by HIV. A comprehensive analysis of why the FC has not reached its full potential is attributed to a lack of acceptability in the international policy arena, which has led to a reticence to support its introduction, rather than its acceptability among users.2 Conversely, development of new prevention approaches such as microbicides, medical male circumcision, pre-exposure prophylaxis (PrEP) and vaccines continue to be well-funded despite setbacks and/or research results showing marginal effectiveness. The FC has recently been identified by the Reproductive Health Supplies Coalition as one of several under-used reproductive health tech-
nologies. The Coalition aims to improve choice of these technologies and contribute to country level efforts towards achieving universal access to services and products. A product brief has been developed for each of the under-used technologies which gives information on efficacy, current programme use, manufacturing and registration status of new products, and public sector price agreements.3 In recent years, a number of initiatives have re-energised the female condom landscape. The UN Population Fund (UNFPA) Intensified Global Initiative provides support to 23 countries across the world to implement FC programmes.4 Launched in 2005, this initiative aims to scale up access to FCs through financial and technical support to country programmes. Several participating countries have reintroduced the FC through this initiative, having learned from past mistakes the need to ensure that programming efforts are sustainable. The Universal Access to Female Condoms Joint Programme (UAFC) is also supporting several
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Doi: 10.1016/S0968-8080(12)40659-0
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African countries through the provision of FCs and educational programmes targeting men, youth and women at risk.4,5 Programming support is critical as it has been documented that funding for the product itself, without investment in effective and comprehensive programming, can lead to stock-outs, lack of access and limited availability.1 Analysis of five female condom programmes with high volume distribution found that successful programmes were effective at identifying target populations and ensuring those populations were able to access the method through appropriate channels.6 Female condom distribution world-wide has increased notably; between 2007 and 2010, it doubled from 25 to 50 million units.7 Compared to male condoms, however, based on data compiled by the Reproductive Health Supplies Coalition, FC purchases account for only 0.19% of global condom procurement.3 In South Africa, one of the countries with a well-established FC programme, FC distribution increased to 5.1 million units in 2010; however, male condom distribution increased to 2.5 billion.8 Donor commitment also reflects this imbalance, with FCs representing only 3.2% of total US government donated condoms in 2009.1 Although FC distribution rates lag far behind those of male condoms, there has been significant progress in FC technology. Since 2000, new FC products have become available or are in development, with the aims of reducing unit cost and improving acceptability, with some donor support. One of these is the Woman’s Condom, developed by PATH (Programme for Appropriate Technology in Health), which aims to develop innovative high-impact, low-cost prevention solutions. UAFC has also supported several new FCs in various stages of their development and manufacturing. In other cases, new FCs have been developed by manufacturers of male condoms seeking to diversify their portfolios or with an interest in increasing prevention options. There are recognized challenges in developing new FC products. By far the greatest hurdle are the clinical studies required for regulatory purposes. In the US, FCs are classified as Class III devices by the United States Food and Drug Administration (USFDA), unlike male condoms, which are designated as Class II medical devices. Class III status was applied to FCs for safety reasons by USFDA as there was no history of FC contraceptive effectiveness. In Europe, FCs have the same classification as male condoms (Class IIb)
and the regulatory process is therefore simpler and quicker. Because the new FCs are considered a new type of medical device most regulatory agencies require evidence from clinical trials to confirm that the products provide levels of protection against STIs and pregnancy that are at least equivalent to those for male condoms. Depending upon the design of the device and the specific regulatory agency concerned, this evidence can range from studies demonstrating non-inferiority with respect to a male condom in terms of failure rates (e.g. breakage and slippage) through to contraceptive efficacy rates. This is important to note, since the existing market for FCs is almost entirely donor driven with a very limited demand in the private sector. Donors purchasing FCs as part of international aid programmes normally require the products to be pre-qualified by UNFPA. Some US-based procurement agencies may require USFDA marketing authorization, which in turn may be dependent on the satisfactory outcome of contraceptive efficacy studies. Manufacturers wishing to develop and market FCs need to target the donor market, yet to do so requires considerable investment in testing and clinical trials, which are prohibitively costly and take years to complete. Emerging FC manufacturers urgently need more guidance to enable them to undertake all the required testing and compile the required documentation needed for regulatory approval. Without regulatory approval many FC manufacturers cannot enter the market or be considered for procurement by donor agencies. The International Organization for Standards (ISO) has developed clear standards for male condoms with guidance on specifications and test methods used to verify the quality of male condoms. The international standard for female condoms, ISO 25841, was published in 2011 and had not previously been available to manufacturers. For most of the newer designs of FC this has meant that the effectiveness and safety of each product has had to be evaluated by experts on a product-by-product basis. The WHO Department of Reproductive Health and Research (WHO RHR) established a Female Condom Technical Review Committee in 2006. This expert group was convened to evaluate FC manufacturer’s dossiers in order to make recommendations for bulk procurement of FCs that met all required specifications. The WHO/UNFPA Generic Female Condom Specification is now close to finalization and should 189
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be available on the UNFPA website before the end of 2012. The specification forms the basis of the UNFPA pre-qualification scheme for FCs and covers the following key areas:
• • • •
General requirements specify the clinical performance requirements. Performance requirements specify the essential performance attributes. Design requirements are mainly concerned with acceptability to the end user. Packaging requirements that purchasers may specify, with particular requirements depending upon the target population.
Female condoms available now or in development Although the different FCs available now or in development often have unique design features, there are many similarities between them with respect to function. The following are common components of a female condom:
• • • •
a sheath that lines the vagina and may extend to cover, or partially cover, the external genitalia; an external anchor retention feature that prevents the condom from being pushed into the vagina, commonly a ring or frame which also serves as a removal mechanism; an internal retention feature to keep the condom within the vagina, e.g. a ring or foam sponge;* a product insertion feature that facilitates insertion into the vagina; the internal retention feature may also serve this function.
The FC products described below are either available now or are expected to be available within the next two to five years. This list is comprehensive; it has been compiled from a range of sources, including various meetings and committees involving UNFPA, WHO and a range of condom manufacturers. The detailed specifications for each product are listed in Figures 1–8 with a visual of each device, along with attributes such as design, materials and lubricants, and information about the manufacturers. The FC2â The FC2 replaced the polyurethane FC1, which had been available since 1993. It became avail*Some studies of FCs in development are investigating stability without the use of an internal mechanism.
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able in some countries in 2005. The FC2 is similar in specification, function and appearance to the FC1, but is made of synthetic nitrile rubber latex (Figure 1). The manufacture of FC1 ceased in 2009; however, it has a five-year shelf-life and existing supplies may still be used until 2014. FC2 is manufactured by a dipping process on high volume, automated production lines. This process change, in conjunction with the conversion to a nitrile material, resulted in a decrease in cost of approximately 25% as compared to the FC1. The performance and acceptability of FC2 is comparable to FC1.9,10 In these studies, no difference was found in failure rates for breakage, slippage or invagination. Following completion of the technical review process by WHO, FC2 was found acceptable for bulk procurement by all UN agencies in 2007. In 2009, it was approved by US FDA. As the FC1 was the first FC to enter the market, there is a body of research published on its contraceptive efficacy,11–13 acceptability,14 function,9,15,16 and prevention of sexually transmitted infections (STI).17 There are no data available on the contraceptive efficacy or STI prevention capability of the FC2. Since FC1 and FC2 are similar in design and specification, approval of FC2 was granted by US FDA on the basis of the results of a comparative, noninferiority clinical trial of device function.9 The Woman’s Condom The Woman’s Condom is made of polyurethane and is inserted using a dissolving capsule. The sheath of the condom is enclosed in a capsule which dissolves after insertion (Figure 2) releasing the condom within the vagina. The dissolving capsule is made of polyvinyl alcohol, the same material used to make vaginal contraceptive film (C-film). The four foam shapes on the body of the condom cling lightly to the vaginal wall to ensure stability. The condom is not pre-lubricated. It comes with a sachet of water-based lubricant that is applied by the user. Acceptability trials have shown it is acceptable to users.18,19 The performance has also been found to be similar to FC2.20 A pregnancy effectiveness study is near completion in the United states. Results are expected in 2013. In 2008, PATH licensed the Dahua Medical Apparatus Co., Shanghai, China, to manufacture and distribute the Woman’s Condom. The Phoenurse The Phoenurse FC is made of polyurethane and pre-lubricated with a silicone lubricant. The body
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of the condom is slightly longer than the FC2 and is dumbbell-shaped. Phoenurse is marketed with an insertion device which attaches to the inner ring and can be used to insert the condom into the vagina (Figure 3). The inner ring can also be used for insertion in a similar way to FC2. The Phoenurse FC is approved for use in China but not sold outside the country at this writing. A recent trial in China found that it is acceptable to women, and its functional performance in terms of failures such as breakage and slippage is similar to FC1.21 A further clinical trial to assess functional performance and acceptability of the Phoenurse compared to FC2 will commence in 2013. The Cupidâ and Cupid2 The Cupid â FC (Figure 4) is inserted using a medical grade, non-biodegradable sponge which can be compressed between the fingers and used to push the condom into the vagina. The sponge 192
also holds the condom in place during use and acts in a similar way to the inner ring in other female condoms, for insertion and stability. The Cupid comes in both natural and pink colours and is the only FC that is vanilla scented. This FC was prequalified in June 2012 for bulk procurement by UNFPA following recommendations from the WHO/UNFPA Female Condom Technical Review Committee. It is the second condom that can now be procured globally for the public sector donor market. It is already available in India, Brazil, Indonesia, Netherlands and South Africa and has recently been launched in Mozambique by PSI under the name Jeitosa. (www.condoms4all. org, 17 July 2012) The Cupid2 is identical to the Cupid â but is slightly shorter with a smaller sponge. The manufacturer has developed this FC for the Asian market where smaller male condoms are also commonly used. However, this condom is still being tested,
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and clinical trials to ensure it functions adequately are due to commence in 2013. If made available in future, this will give women an option to use an FC with a smaller fit. The Panty (Condon Femenino) The Panty (Condon Femenino) has a distinct design compared to other FCs (Figure 5). The panty holds the condom in place during intercourse and has the same function as the outer ring or frame of other FCs. This FC cannot be used without the panty. The nylon panty itself is reusable. A new condom sheath must be inserted and secured into the panty each time and removed after one use. The panty can then be washed and a new condom can be fitted The Panty FC does not have an insertion device like a ring or a sponge. Instead, once the panty is on, the condom sheath is pushed into the vagina using a finger or the penis. Panty FCs are more expensive than the other FCs described here and are generally less available. The product can be purchased as a single panty and condom or a panty with a packet of 3 condoms. This FC is under review by the WHO/UNFPA Female Condom Technical Review Committee, and clinical work on function and acceptability is due to be undertaken in 2013. The HLL The HLL FC, named after the manufacturer as it is too new to have a name, is similar in design and appearance to the FC2, with an inner and outer circular ring (Figure 6) but made of natural rubber latex. This FC has only been in development since 2011 and is at this writing in process of undergoing the required testing. A clinical trial to evaluate its function will commence in 2013. The Origamiä ä The Origamiä is also currently in development (Figure 7). This FC is made of silicone that has been formulated specifically to provide high elongation and durability during vaginal intercourse. The product is folded “origami style” and inserted by pushing the folded material into the vagina. The design is intended to minimize its size for ease of insertion. After insertion, the condom will deploy to its full length during intercourse. The silicone formulation of the material was chosen for its robustness and potential to be a viable, re-usable condom. The possibility of re-use, if found to be feasible, has great potential for low-
ering the cost. Phase I testing as a re-usable device will commence in the US in 2014. The VA w.o.wâ (Condom Feminine) The VA w.o.w â (worn of women), Condom Feminine encases a medical-grade, non-biodegradable sponge at the closed end of the device, similar to the Cupid. The sponge is used for insertion, and the condom is the shortest of all the FCs (Figure 8). In studies conducted in India and South Africa, this condom was found to be acceptable to users.20,22 Currently, manufacture of the product is suspended, possibly related to change of ownership of the factory.
Discussion New female condom designs will increase the options for couples who choose to use them as their prevention method. Some designs are also expected to reduce cost, in particular those made of natural rubber latex (the same material as male condoms), bringing them closer to the unit price of male condoms. Specific FC purchase prices vary considerably, however, and within the main donor-funded public sector market, individual negotiations and volume purchased will affect unit price. However, the estimate for the FC2 in 2012 was US$0.57/unit with potential lower cost, depending on volume.3 The approval of Cupidâ in 2012 is an important step forward, with an estimated price of US$0.35 per unit for 2012.7 This will encourage competition to lower costs for countries and increase choice. Although good evidence for the effect of choice of method on increased uptake of contraceptive methods is limited, a systematic review of the evidence in 2006 supported the contention that increased choice for women is associated with increased uptake and with better health outcomes (such as lower pregnancy rates and fewer STIs). Further, women given a choice exercise it and continue use of their chosen contraceptives to a greater degree than those denied a choice of method.23,24 A study in which women had the opportunity to use the FC2, the Woman’s Condom and the VA w.o.w and then choose which one they preferred found that all three were acceptable, with the design of the Woman’s Condom the most liked. Almost all participants expressed a preference for one of the three by the end of the study.20 As more FCs become available, careful planning will be needed within programmes. Each female condom requires product-specific training, 193
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instruction and informational materials and programme planners must be aware of this to ensure correct use, particularly in programmes supplying a number of products.25 Once women are used to these products, however, the need for such detailed instruction will be reduced.26 Renewed interest in female condoms, the emergence of a variety of new designs, and initiatives to facilitate their journey through the regulatory process are all promising. Raising the profile of FCs through a wider range of products may also increase awareness that the WHO Essential Medicines list currently includes “condoms” but does not specify male and female condoms.27 For countries adopting this list, female condoms may not be assumed to be part of the “condoms” category. This presents a significant barrier to female condom procurement for countries, but ongoing discussions have not yet led to this being rectified. Other challenges also remain, including the requirement to conduct more pregnancy and STI/HIV prevention effectiveness studies with the new designs, thus providing more evidence for donors, programme managers and users. The body of evidence available for both pregnancy and STI/HIV prevention effectiveness is exclusively for FC1, now discontinued. However, these studies are expensive and donors are reluctant to support them. Recent advances in the detection of biomarkers of semen in the vagina are important, in that they could help evaluate the safety of barrier methods such as female condoms and diaphragms.28 Prostate-specific antigen (PSA) is one of these biomarkers and research is ongoing to validate PSA data in pregnancy efficacy and STI trials. Recommendations have been made to the USFDA to accept evidence that the presence of PSA in the vagina can be used to detect female condom failures.29 The possibility of re-use of female condoms was once proposed as a way to reduce their high cost relative to male condoms, and research was done to investigate the robustness of the FC1 in this regard.30 WHO refused to endorse re-use, however, and the impetus was lost.31 FC1 was made of polyurethane, a far stronger material than synthetic and natural rubber latex. With FC1 no longer available and many new female condoms made of natural rubber latex, re-use is not feasible, as the condoms would deteriorate with even one washing. In the future, some female condoms may have the potential for re-use, but this will be entirely dependent on their design and the 194
material they are made of, and would require regulatory approval for this indication, as well as specific instructions for re-use. There are initiatives from UNFPA and the WHO Department of Reproductive Health and Research that have provided support to emerging FC manufacturers. Two workshops have been held to date which have taken manufacturers through all the steps of the development and regulatory processes. The existing manufacturers are all private companies, who will only consider moving into female condom development and manufacture if they can foresee some profit from it. However, several of the manufacturers are also committed to improving protection options for women and are moving into the field despite the expense and lengthy testing and regulatory processes. The female condom is unique in that it can be inserted by the woman, either just before or well before sex, and insertion is not reliant on the partner. It is currently also the only dual protection alternative to the male condom. The potential for the method to help to empower women through increased opportunities to discuss and negotiate safer sex needs to be capitalized on further.32
Paper Doll campaign
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A number of global initiatives to promote FCs have recently been launched, signifying a renewed interest in female condoms. In 2009, the Universal Access to Female Condoms Joint Programme initiated an international advocacy platform to broaden and strengthen the international support base for FCs. This platform (www.condoms4all. org/) has made considerable progress in raising awareness and demand for FCs, including the “Paper Doll Campaign”, which ran up to and during the International AIDS Conference in Washington DC in July 2012. Thousands of people wrote messages on the paper dolls asking for more choice, lower prices, and improved access to female condoms. This culminated in the display of thousands of the dolls on the last day
of the Conference. The first Global Female Condom Day (www.nationalfccoalition.org/) was held on 12 September 2012, and many organisations marked the event. The pre-qualification by UNFPA of the FC2 for the global donor market, with several more on the horizon, coupled with the potential for lower prices and renewed efforts to increase demand, are strong indications that female condoms are finally being taken more seriously as a viable method of both pregnancy and STI/HIV prevention. Acknowledgements We would like to acknowledge the William and Flora Hewlett Foundation for support to authors Beksinska and Smit.
References 1. Center for Health and Gender Equity. Female condoms and US foreign assistance: an unfinished imperative for women’s health. Washington, DC, 2011. 2. Peters A, Jansen W, van Driel F. The female condom: the international denial of a strong potential. Reproductive Health Matters 2010;18(35):119–28. 3. Reproductive Health Supplies Coalition. Caucus on new and underused reproductive health technologies. Product brief: female condom. www.rhsupplies.org/workinggroups/caucus-on-newunderused-rh-technologies.html. 4. www.unfpa.org/hiv/female.htm#global. 5. www.condoms4all.org. 6. Peterson K, Herman L, Fiske L, et al. Smarter programming of the female condom: increasing its impact on HIV prevention in the developing world. www.fsg.org/ tabid/191/ArticleId/60/Default.aspx?srpush=true. 2008. 7. UNFPA. HIV prevention gains momentum: UNFPA; 2011. 8. UNAIDS. Country Progress Report on the Declaration of Commitment on HIV/AIDS. Final Report, Republic of South Africa, 2010. www.unaids.org/en/dataanalysis/ monitoringcountryprogress/2010progressreportsubmitted bycountries/southafrica_2010_country_progress_ report_en.pdf. 9. Beksinska M, Smit J, Mabude Z, et al. Performance of the Reality polyurethane female condom and a synthetic latex prototype: a randomized cross-over trial among South African women. Contraception 2006;73:386–93. 10. Smit J, Beksinska ME, Mabude Z, et al. Acceptability of the Reality polyurethane female condom and a synthetic latex prototype: A randomized cross-over trial among South African women. Contraception 2006;73:394–98. 11. Bounds W, Guillebaud J, Newman GB. Female condom (Femidon). A clinical study of its use-effectiveness and
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patient acceptability. British Journal of Family Planning 1992;18:36–41. Farr G, Galbenick H, Sturgen K, et al. Contraceptive efficacy and acceptability of the female condom. American Journal of Public Health 1994;84:1960–64. Trussell J. Contraceptive efficacy of the Reality female condom. Contraception 1998;58:147–48. World Health Organization. The female condom: a review. Geneva: WHO; 1997. Valappil T, Kelaghan J, Macaluso M, et al. Female and male condom failure among women at high risk of sexually transmitted disease. Sexually Transmitted Diseases 2005;32(1):35–43. Leeper MA, Conrady M. Preliminary evaluation of REALITY, a condom for women to wear. Advances in Contraception 1989;5:229–35. Vijayakumar G, Mabude Z, Smit J, et al. A review of female-condom effectiveness: patterns of use and impact on protected sex acts and STI incidence. International Journal of STDs & AIDS 2006;17:652–59. Coffey PS, Kilbourne-Brook M, Austin G. Short-term acceptability of the PATH Woman’s Condom among couples at three sites. Contraception 2006;73:588–93. Schwartz JL, Barnhart K, Creinin MD, et al. Comparative crossover study of the PATH Woman’s Condom and the FC Female Condomâ. Contraception 2008;78: 465–73. Joanis C, Beksinska M, Hart C, et al. Three new female condoms: which do women prefer? Contraception 2011;83:248–54. Hou LY, Qiu HY, Zhao YZ, et al. A crossover comparison of two types of female condom. International Journal of Gynecology & Obstetrics 2010;108:214–18.
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M Beksinska et al. Reproductive Health Matters 2012;20(40):188–196 22. Smita J, Neelam J, Rochelle DY, et al. Comparative acceptability study of the Reality female condom and version 4 of modified Reddy female condom in India. Contraception 2005;72:366–71. 23. Systematic Review of Contraceptive Medicines. “Does choice make a difference?” October 2006. http://archives.who.int/eml/expcom/expcom15/ applications/sections/ContraChoiceReview.pdf. 24. Jain AK. Fertility reduction and the quality of family planning services. Studies in Family Planning 1989;20:1–16. 25. MatCH. Developing a Strategy for female condom parallel programming: proceedings of an expert meeting. Durban, 23–24 November 2011. www.match.org.za/ news/Pages?StrategyforFemaleCondom.aspx. 26. Beksinska M, Smit, Joanis C, et al. Practice makes perfect: Reduction in female condom failures and user problems with short-term experience in a randomized trial. Contraception 2012;86:127–31. 27. World Health Organization. WHO Model List of Essential Medicines, 17th list. Geneva: WHO, 2011.
Résumé Les préservatifs masculins et féminins sont actuellement les seules méthodes efficaces de double protection contre les grossesses non désirées et la transmission des IST et du VIH. Ces dernières années, le plaidoyer et le soutien aux programmes de préservatif féminin et la distribution accrue de ces produits ont joué un rôle important pour insister auprès des donateurs, des décideurs et des responsables de programmes sur l’importance du préservatif féminin comme outil essentiel de la double prévention. De plus, l’apparition de nouveaux produits, différents en conception et matériel, peut en diminuer le coût et améliorer l’acceptabilité. La conception de nouveaux préservatifs féminins rencontre des écueils, le principal étant les études cliniques nécessaires à des fins régulatrices. Néanmoins, plusieurs nouveaux produits sont maintenant disponibles dans des pays sélectionnés et d’autres se rapprochent du stade final de l’agrément, après quoi ils deviendront largement disponibles. Ces nouveaux produits, qui seront peut-être aussi plus abordables, multiplieront les options et les choix pour les couples qui veulent utiliser le préservatif féminin comme méthode de prévention. Nous étudions ici les préservatifs féminins disponibles et ceux qui sont en cours d’élaboration et devraient être commercialisés d’ici deux à cinq ans.
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30.
31.
32.
www.who.int/medicines/publications/essentialmedicines/ en/index.html. Mauck CK, Doncel GF, and Biomarkers of Semen Exposure Clinical Working Group. Biomarkers of semen in the vagina: applications in clinical trials of contraception and prevention of sexually transmitted pathogens including HIV. Contraception 2007;75:407–19. Mauck CK, Weaver MA, Schartz JL, et al. Critical next steps for female condom research: report from a workshop. Contraception 2009;79:339–44. Beksinska ME, Rees VH, Dickson-Tetteh KE, et al. Structural integrity of the female condom after multiple uses, washing, drying and re-lubrication. Contraception 2001;63(1):33–36. World Health Organization. Considerations Regarding Re-use of the Female Condom: Information Update, 10 July 2002. In: Reproductive Health Matters 2002;10(20):182–86. Gollub EL. The female condom: tool for women’s empowerment. American Journal of Public Health 2000;90(9):1377–81.
Resumen Actualmente, los condones masculinos y femeninos son los únicos métodos eficaces de doble protección contra el embarazo no intencional y la transmisión de ITS y VIH. En los últimos años, la promoción y defensa de programas de condón femenino (CF) y mayor distribución han desempeñado un papel decisivo en recalcar a donantes, formuladores de políticas y gerentes de programas la importancia de los CF como herramientas esenciales para la doble prevención. Más aún, la emergencia de nuevos productos de CF, que difieren en diseño y materiales, tiene el potencial de reducir el costo y mejorar su aceptación. Existen obstáculos para crear nuevos productos de CF; el mayor es los estudios clínicos exigidos para fines normativos. Sin embargo, en algunos países ahora hay varios diseños disponibles y algunos están progresando hacia las etapas finales de la aprobación reglamentaria, tras la cual estarán disponibles de manera más extendida. Los nuevos diseños de CF, que posiblemente sean menos costosos, ampliarán las opciones de parejas que desean usar CF como método de prevención. Aquí se revisan los productos de CF actualmente disponibles y aquellos aún en desarrollo, que se espera estén disponibles en los próximos dos a cinco años.