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A multicenter, randomized, phase III study of two low-dose levonorgestrel intrauterine systems (LNG-IUSs) for contraception: a subgroup analyses of efficacy and safety in nulliparous versus parous women
Abstracts / Contraception 88 (2013) 297–318 be used in quality improvement efforts, including presenting the data back to clinicians to increase assessment and guiding training efforts. In this case, results indicated the need for provider trainings to focus more time on how to assess and have discussions with patients around sexual violence and reproductive coercion, and curricula and activities have been modified.
P8 SEXUAL HEALTH RANKINGS: A COMPOSITE INDEX AND RANKING OF SEXUAL HEALTH IN THE UNITED STATES—50 STATES AND THE DISTRICT OF COLUMBIA Downs M Variance, LLC, Lebanon, NH, USA Andelloux M Objectives: This project aims to develop a comprehensive composite measure of sexual health in the United States and compare the overall sexual health of state populations. The composite indicator and state rankings are intended to facilitate evaluation and planning of policies and programs to advance sexual health in the United States. Method: The World Health Organization has developed a comprehensive definition of sexual health that emphasizes wellness, accounts for the determinants of health, and encompasses human rights, sexual expression and identity and sexual pleasure. We have constructed a composite indicator of sexual health based on the World Health Organization definition, using publicly available data. The composite index is made up of 26 individual indicators. Indicator values are normalized to standard scores to enable comparison. The standard scores are weighted before being aggregated into a composite score. We developed an original weighting scheme focused on enabling comprehensive measurement of sexual health and reducing bias based on availability of data. Results: We find considerable state-level variation in sexual health outcomes — including measures of sexual satisfaction, morbidity, reproductive health and violence — and in factors that influence sexual health — including state laws, health systems and social and economic conditions. The first edition of Sexual Health Rankings, for the year 2012, ranks Vermont highest (no. 1) in sexual health, and Mississippi as the least sexually healthy state (no. 51). Conclusions: We demonstrate that it is feasible to construct a composite indicator of sexual health using published data only. Nevertheless, we find critical gaps in surveillance, monitoring and evaluation of sexual health in the United States, especially a lack of measures related to positive aspects of sexual health.
P9 A MULTICENTER, RANDOMIZED, PHASE III STUDY OF TWO LOW-DOSE LEVONORGESTREL INTRAUTERINE SYSTEMS (LNG-IUSS) FOR CONTRACEPTION: A SUBGROUP ANALYSES OF EFFICACY AND SAFETY IN NULLIPAROUS VERSUS PAROUS WOMEN Drosman SR Genesis Center for Clinical Research, San Diego, CA, USA Gemzell-Danielsson K, Lynen R, Rosen K, Nelson AL Objectives: To evaluate the efficacy and safety of two low-dose LNG-IUSs in nulliparous women. Method: In this multicenter, open-label, Phase III study, women aged 18–35 years with regular menstrual cycles (21–35 days) and requesting contraception were randomized to LNG-IUS12 or LNG-IUS16 (initial in vitro release
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rate: 12 μg/day and 16 μg/day, respectively). Treatment duration was 3 years for LNG-IUS12 (complete) and 5 years for LNG-IUS16 (ongoing). The primary outcome was the pregnancy rate calculated as the Pearl Index (PI). Subgroup analyses of data for nulliparous versus parous women treated with LNG-IUS12 and LNG-IUS16 for 3 years are presented. Results: In total, 2884 women were included in the full analysis set: 1130 (39.2%) were nulliparous (LNG-IUS12, n= 556; LNG-IUS16, n= 574); 1754 were parous (LNG-IUS12, n=876; LNG-IUS16, n=878). The 3-year PIs (95% confidence intervals) were similar in both arms (LNG-IUS12, 0.33 [0.16, 0.60]; LNG-IUS16, 0.31 [0.15, 0.57]), with no significant difference between nulliparous (LNG-IUS12, 0.36 [0.10, 0.92]; LNG-IUS16, 0.25 [0.05, 0.73]) and parous women (LNG-IUS12, 0.31 [0.11, 0.67]; LNGIUS16, 0.35 [0.14, 0.72]). Similarly, the cumulative failure rate over 3 years was similar in both arms (LNG-IUS12, 0.009 [0.005, 0.017]; LNG-IUS16, 0.010 [0.005, 0.018]), with no significant difference between nulliparous (LNG-IUS12, 0.010 [0.004, 0.026]; LNG-IUS16, 0.008 [0.003, 0.026]) and parous women (LNG-IUS12, 0.009 [0.004, 0.019]; LNG-IUS16, 0.010 [0.005, 0.022]). The early discontinuation rate due to withdrawal of consent or adverse events (AEs, both treatment groups combined) was 25.2% and 20.7% for nulliparous and parous women, respectively. In the nulliparous subset, 3.6% discontinued because of progestin-related AEs (as classified by the investigator) (LNG-IUS12, 3.8%; LNG-IUS16, 3.5%) and 5.4% discontinued because of change in bleeding, including amenorrhea (LNGIUS12, 5.2%; LNG-IUS16, 5.6%). Across both treatment groups combined, in nulliparous and parous women, respectively, the incidence of ectopic pregnancy over 3 years was 0.4% and 0.3%; the incidence of pelvic inflammatory disease over 3 years was 0.1% and 0.6%; and the rate of complete/partial expulsion over 3 years was 2.2% and 4.2%, respectively. Conclusions: LNG-IUS12 and LNG-IUS16 are safe and highly effective over 3 years of use, regardless of parity.
P10 HOW DO MEDICAL STUDENTS FEEL ABOUT SEX? INSIGHT INTO MEDICAL STUDENT ATTITUDES TOWARDS SEXUAL HEALTH Foy L Christiana Care Health System, Newark, DE, USA Objectives: Participants will be able to (1) better understand medical students' baseline comfort and confidence level in regards to obtaining sexual health history from patients, (2) identify common pre-conceived beliefs medical students have towards patients regarding sexual health issues, (3) apply this knowledge towards improving/enhancing medical student education in sexual health at their institution. Method: Jefferson Medical College 3rd and 4th year medical students rotate through the Department of Family & Community Medicine for clinical rotations at Christiana Care Health System. Approximately 6 students rotate through the Family Medicine Center every 6 weeks to gain knowledge in primary care & family medicine, for a total of roughly 50 students per academic year. As part of their primary care education within our department, we have developed a curriculum aimed at enhancing their knowledge of sexual and reproductive health. Results: Students have been completing a pre-lecture survey regarding their attitudes, comfort level and preconceptions about sexual and reproductive health. Their responses are still being collected, but results currently show an overwhelming percent of these medical students feel that they still have a lot to learn about how to address sexual/reproductive health concerns in patients. They also hold a number of common misconceptions that need to be de-bunked, including that ~ 75% of them think patients will bring up needs for contraception on their own without prompting, which we have seen to not necessarily be true. Results are still actively being collected and will not be final until June 2013. Conclusions: Thus far, medical students overall feel more uncomfortable discussing personal, sensitive information about reproductive health and hold a
P8 SEXUAL HEALTH RANKINGS: A COMPOSITE INDEX AND RANKING OF SEXUAL HEALTH IN THE UNITED STATES—50 STATES AND THE DISTRICT OF COLUMBIA Downs M Variance, LLC, Lebanon, NH, USA Andelloux M Objectives: This project aims to develop a comprehensive composite measure of sexual health in the United States and compare the overall sexual health of state populations. The composite indicator and state rankings are intended to facilitate evaluation and planning of policies and programs to advance sexual health in the United States. Method: The World Health Organization has developed a comprehensive definition of sexual health that emphasizes wellness, accounts for the determinants of health, and encompasses human rights, sexual expression and identity and sexual pleasure. We have constructed a composite indicator of sexual health based on the World Health Organization definition, using publicly available data. The composite index is made up of 26 individual indicators. Indicator values are normalized to standard scores to enable comparison. The standard scores are weighted before being aggregated into a composite score. We developed an original weighting scheme focused on enabling comprehensive measurement of sexual health and reducing bias based on availability of data. Results: We find considerable state-level variation in sexual health outcomes — including measures of sexual satisfaction, morbidity, reproductive health and violence — and in factors that influence sexual health — including state laws, health systems and social and economic conditions. The first edition of Sexual Health Rankings, for the year 2012, ranks Vermont highest (no. 1) in sexual health, and Mississippi as the least sexually healthy state (no. 51). Conclusions: We demonstrate that it is feasible to construct a composite indicator of sexual health using published data only. Nevertheless, we find critical gaps in surveillance, monitoring and evaluation of sexual health in the United States, especially a lack of measures related to positive aspects of sexual health.
P9 A MULTICENTER, RANDOMIZED, PHASE III STUDY OF TWO LOW-DOSE LEVONORGESTREL INTRAUTERINE SYSTEMS (LNG-IUSS) FOR CONTRACEPTION: A SUBGROUP ANALYSES OF EFFICACY AND SAFETY IN NULLIPAROUS VERSUS PAROUS WOMEN Drosman SR Genesis Center for Clinical Research, San Diego, CA, USA Gemzell-Danielsson K, Lynen R, Rosen K, Nelson AL Objectives: To evaluate the efficacy and safety of two low-dose LNG-IUSs in nulliparous women. Method: In this multicenter, open-label, Phase III study, women aged 18–35 years with regular menstrual cycles (21–35 days) and requesting contraception were randomized to LNG-IUS12 or LNG-IUS16 (initial in vitro release
309
rate: 12 μg/day and 16 μg/day, respectively). Treatment duration was 3 years for LNG-IUS12 (complete) and 5 years for LNG-IUS16 (ongoing). The primary outcome was the pregnancy rate calculated as the Pearl Index (PI). Subgroup analyses of data for nulliparous versus parous women treated with LNG-IUS12 and LNG-IUS16 for 3 years are presented. Results: In total, 2884 women were included in the full analysis set: 1130 (39.2%) were nulliparous (LNG-IUS12, n= 556; LNG-IUS16, n= 574); 1754 were parous (LNG-IUS12, n=876; LNG-IUS16, n=878). The 3-year PIs (95% confidence intervals) were similar in both arms (LNG-IUS12, 0.33 [0.16, 0.60]; LNG-IUS16, 0.31 [0.15, 0.57]), with no significant difference between nulliparous (LNG-IUS12, 0.36 [0.10, 0.92]; LNG-IUS16, 0.25 [0.05, 0.73]) and parous women (LNG-IUS12, 0.31 [0.11, 0.67]; LNGIUS16, 0.35 [0.14, 0.72]). Similarly, the cumulative failure rate over 3 years was similar in both arms (LNG-IUS12, 0.009 [0.005, 0.017]; LNG-IUS16, 0.010 [0.005, 0.018]), with no significant difference between nulliparous (LNG-IUS12, 0.010 [0.004, 0.026]; LNG-IUS16, 0.008 [0.003, 0.026]) and parous women (LNG-IUS12, 0.009 [0.004, 0.019]; LNG-IUS16, 0.010 [0.005, 0.022]). The early discontinuation rate due to withdrawal of consent or adverse events (AEs, both treatment groups combined) was 25.2% and 20.7% for nulliparous and parous women, respectively. In the nulliparous subset, 3.6% discontinued because of progestin-related AEs (as classified by the investigator) (LNG-IUS12, 3.8%; LNG-IUS16, 3.5%) and 5.4% discontinued because of change in bleeding, including amenorrhea (LNGIUS12, 5.2%; LNG-IUS16, 5.6%). Across both treatment groups combined, in nulliparous and parous women, respectively, the incidence of ectopic pregnancy over 3 years was 0.4% and 0.3%; the incidence of pelvic inflammatory disease over 3 years was 0.1% and 0.6%; and the rate of complete/partial expulsion over 3 years was 2.2% and 4.2%, respectively. Conclusions: LNG-IUS12 and LNG-IUS16 are safe and highly effective over 3 years of use, regardless of parity.
P10 HOW DO MEDICAL STUDENTS FEEL ABOUT SEX? INSIGHT INTO MEDICAL STUDENT ATTITUDES TOWARDS SEXUAL HEALTH Foy L Christiana Care Health System, Newark, DE, USA Objectives: Participants will be able to (1) better understand medical students' baseline comfort and confidence level in regards to obtaining sexual health history from patients, (2) identify common pre-conceived beliefs medical students have towards patients regarding sexual health issues, (3) apply this knowledge towards improving/enhancing medical student education in sexual health at their institution. Method: Jefferson Medical College 3rd and 4th year medical students rotate through the Department of Family & Community Medicine for clinical rotations at Christiana Care Health System. Approximately 6 students rotate through the Family Medicine Center every 6 weeks to gain knowledge in primary care & family medicine, for a total of roughly 50 students per academic year. As part of their primary care education within our department, we have developed a curriculum aimed at enhancing their knowledge of sexual and reproductive health. Results: Students have been completing a pre-lecture survey regarding their attitudes, comfort level and preconceptions about sexual and reproductive health. Their responses are still being collected, but results currently show an overwhelming percent of these medical students feel that they still have a lot to learn about how to address sexual/reproductive health concerns in patients. They also hold a number of common misconceptions that need to be de-bunked, including that ~ 75% of them think patients will bring up needs for contraception on their own without prompting, which we have seen to not necessarily be true. Results are still actively being collected and will not be final until June 2013. Conclusions: Thus far, medical students overall feel more uncomfortable discussing personal, sensitive information about reproductive health and hold a