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4 regimen in the treatment of acne: lesion counts and investigator & subject assessments
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Poster presentations / International Journal of Gynecology & Obstetrics 107S2 (2009) S413–S729
of Implanon® by the physician. Insertion of the implant was evaluated as very easy or easy by 96.4%. Removal of Implanon® was very easy or easy for 71.9% and not very difficult for 17.4%.of the participating physicians. The majority of women expressed satisfaction or neutral attitude to her Implanon® use, 1/5 of the group was dissatisfied (21.1%). The dissatisfaction among the physicians was even lower (13%). Conclusion: Implanon® was proven to be a good long term contraceptive method for the majority of its users in the Czech Republic. P725 A novel non-invasive management of contraception with dysfunctional uterine bleeding (DUB): indomethacin releasing copper device (IR Cu IUD) M. Khairy1 , N. Al-Oraby2 , M. Abdhady2 , M. Ramadan2 , M. Rizk2 , M. Farag2 . 1 Benha Faculty of Medicine, Benha University, 2 Benha Faculty of Medicine, Benha University DUB is a common distressing complaint during the childbearing period. Medical systemic treatment is usually the first line of treatment. If this fails, surgical intervention is the only left solution. “IR Cu IUD” is a noval relatively non-invasive innovation for management of this problem before resorting to surgery. This study included 40 women attending Benha University Hospital and suffering from DUB after exclusion of any organic lesion. HB% and the mean blood loss (MBL) were properly assessed before the easy outpatient insertion of “Yuangong 220 IR Cu IUD”. A follow up study after 3, 6, 9 months showed significant reduction in the menstrual blood flow after each follow up period (p < 0.001). Comparative HB% assessment showed significant increase in each follow up period (p < 0.001). This points to the value of this new non-invasive breakthrough line of treatment for DUB with contraception. However, a bigger no. and longer follow up periods are mandatory for fair evaluation. P726 Post partum IUCD – A new method in post partum contraception H.A. Khatun. Ad-din Womens Medical College and Hospital, Dhaka University, Bangladesh Objectives: To meet the unmet need with a safe, convenient and cost effective postpartum contraceptive method. Materials and Methods: PostPartum Intrauterine Contraceptive Device (PPIUCD) is inserted within 10 minutes after Normal Vaginal Delivery (NVD)and during Caesarean Section (CS) just after removal of placenta, before closing of uterus and between 10 minutes and 48 houres after NVD by a Kelly Forcep. A client delivered in a hospital irrespective of her para with informed choice is eligible for a PPIUCD. Practical training is needed for doctors and nurses on PPIUCD along with infection prevention and counseling. Besides orientation on PPIUCD is needed for family planning workers and counselors. Cu-T 380A and Kelly Forceps are needed for PPIUCD along with other instruments and supplies. Results: During March, 08–February, 2009, 24 clients received IUCD after NVD and 62 received during CS at AD-DIN Hospital, Dhaka. No major difficulties for insertion. Follow up: We followed up the clients during PNC visits by history taking, physical examination and ultrasonoghaphy. There was one case on the process of expulsion, one client complained of slight irregular bleeding and another one complained of abdominal pain. Number of clients needed removal was 3. Conclusion: PPIUCD is a long term, reversible, not affecting breast feeding and suitable method for a woman delivered in a hospital. For its sustainability, conselling to women on PPIUCD during ANC and availability of round the clock trained personnel with required equipment are necessary.
P727 A pooled analysis of two randomized, placebo-controlled studies investigating an oral contraceptive containing ethinylestradiol 20 mcg/drospirenone 3 mg in a 24/4 regimen in the treatment of acne: lesion counts and investigator & subject assessments W. Koltun1 , J. Maloney2 , J. Marr3 , M. Kunz3 . 1 Medical Center for Clinical Research, 2 Cherry Creek Research Inc, 3 Bayer Schering Pharma AG Objective: To investigate the efficacy of a combined oral contraceptive (COC) comprising ethinylestradiol (EE) 20 mcg/drospirenone (drsp) 3 mg, administered in a 24/4 regimen (24 active tablets and 4 inert tablets per cycle; YAZ® ), in the treatment of moderate acne vulgaris. Methods: We pooled two identically-designed studies involving a total of 893 healthy women (aged 14–45 years) with moderate acne, randomized to receive the EE 20 mcg/drsp 3 mg COC (n = 451) or placebo (n = 442) for 6 cycles. Efficacy variables assessed included the change from baseline in papules, pustules, nodules, open comedones, and closed comedones counts, and the percentage of women showing improvement according to the Investigator’s Overall Improvement Rating and Subject’s Overall Self-assessment Rating. Results: The EE 20 mcg/drsp 3 mg 24/4 COC was associated with a significantly greater reduction in individual lesion counts from baseline to endpoint, compared with placebo (p < 0.05). There was a significantly higher odds that a woman was rated as ‘improved’ on the Investigator’s Overall Improvement Rating (odds ratio [OR] 3.84; 95% CI: 2.58, 5.80; p < 0.0001) or that she rated herself as ‘improved’ on the Subject’s Self-Assessment Rating (OR 4.14; 95% CI: 2.75, 6.37; p < 0.0001) in the EE 20 mcg/drsp 3 mg 24/4 COC group than in the placebo group. Conclusion: The EE 20 mcg/drsp 3 mg 24/4 COC is a suitable option for women with moderate acne vulgaris who require contraception. P728 Ethinylestradiol 20 mcg/drospirenone 3 mg oral contraceptive administered in 24/4 regimen in the treatment of moderate acne vulgaris: a pooled analysis of two randomized, double-blind, placebo-controlled studies W. Koltun1 , J. Maloney2 , J. Marr3 , M. Kunz3 . 1 Medical Center for Clinical Research, 2 Cherry Creek Research Inc, 3 Bayer Schering Pharma AG Objective: To investigate the effects of ethinylestradiol (EE) 20 mcg/drospirenone (drsp) 3 mg combined oral contraceptive (COC) administered in a 24/4 regimen (24 active tablets and 4 inert tablets per cycle; YAZ® ) for the treatment of moderate acne vulgaris, based on a pooled analysis of two identically-designed studies. Materials and Methods: A total of 893 healthy females (aged 14– 45 years) with moderate facial acne were randomized to receive either the EE 20 mcg/drsp 3 mg COC (n = 451) or placebo (n = 442) for six cycles, in two US-based studies. The primary outcome measures were mean percent change in acne lesion counts and the investigators’ assessment of acne (Investigator Static Global Assessment scale ratings) from baseline to end point. Results: There were significantly greater reductions in the mean percent change from baseline to end point in inflammatory, noninflammatory and total lesion counts in the EE 20 mcg/drsp 3 mg 24/4 regimen group compared with the placebo group (p < 0.0001). The odds of women in the EE 20 mcg/drsp 3 mg 24/4 regimen COC group having ‘clear’ or ‘almost clear’ skin as rated by the investigators at end point was more than three fold greater than that in the placebo group (odds ratio 3.41; 95% CI: 2.15–5.43; p < 0.0001). Conclusion: A low-dose COC containing EE 20 mcg/drsp 3 mg administered in a 24/4 regimen more effectively reduced acne
Poster presentations / International Journal of Gynecology & Obstetrics 107S2 (2009) S413–S729
of Implanon® by the physician. Insertion of the implant was evaluated as very easy or easy by 96.4%. Removal of Implanon® was very easy or easy for 71.9% and not very difficult for 17.4%.of the participating physicians. The majority of women expressed satisfaction or neutral attitude to her Implanon® use, 1/5 of the group was dissatisfied (21.1%). The dissatisfaction among the physicians was even lower (13%). Conclusion: Implanon® was proven to be a good long term contraceptive method for the majority of its users in the Czech Republic. P725 A novel non-invasive management of contraception with dysfunctional uterine bleeding (DUB): indomethacin releasing copper device (IR Cu IUD) M. Khairy1 , N. Al-Oraby2 , M. Abdhady2 , M. Ramadan2 , M. Rizk2 , M. Farag2 . 1 Benha Faculty of Medicine, Benha University, 2 Benha Faculty of Medicine, Benha University DUB is a common distressing complaint during the childbearing period. Medical systemic treatment is usually the first line of treatment. If this fails, surgical intervention is the only left solution. “IR Cu IUD” is a noval relatively non-invasive innovation for management of this problem before resorting to surgery. This study included 40 women attending Benha University Hospital and suffering from DUB after exclusion of any organic lesion. HB% and the mean blood loss (MBL) were properly assessed before the easy outpatient insertion of “Yuangong 220 IR Cu IUD”. A follow up study after 3, 6, 9 months showed significant reduction in the menstrual blood flow after each follow up period (p < 0.001). Comparative HB% assessment showed significant increase in each follow up period (p < 0.001). This points to the value of this new non-invasive breakthrough line of treatment for DUB with contraception. However, a bigger no. and longer follow up periods are mandatory for fair evaluation. P726 Post partum IUCD – A new method in post partum contraception H.A. Khatun. Ad-din Womens Medical College and Hospital, Dhaka University, Bangladesh Objectives: To meet the unmet need with a safe, convenient and cost effective postpartum contraceptive method. Materials and Methods: PostPartum Intrauterine Contraceptive Device (PPIUCD) is inserted within 10 minutes after Normal Vaginal Delivery (NVD)and during Caesarean Section (CS) just after removal of placenta, before closing of uterus and between 10 minutes and 48 houres after NVD by a Kelly Forcep. A client delivered in a hospital irrespective of her para with informed choice is eligible for a PPIUCD. Practical training is needed for doctors and nurses on PPIUCD along with infection prevention and counseling. Besides orientation on PPIUCD is needed for family planning workers and counselors. Cu-T 380A and Kelly Forceps are needed for PPIUCD along with other instruments and supplies. Results: During March, 08–February, 2009, 24 clients received IUCD after NVD and 62 received during CS at AD-DIN Hospital, Dhaka. No major difficulties for insertion. Follow up: We followed up the clients during PNC visits by history taking, physical examination and ultrasonoghaphy. There was one case on the process of expulsion, one client complained of slight irregular bleeding and another one complained of abdominal pain. Number of clients needed removal was 3. Conclusion: PPIUCD is a long term, reversible, not affecting breast feeding and suitable method for a woman delivered in a hospital. For its sustainability, conselling to women on PPIUCD during ANC and availability of round the clock trained personnel with required equipment are necessary.
P727 A pooled analysis of two randomized, placebo-controlled studies investigating an oral contraceptive containing ethinylestradiol 20 mcg/drospirenone 3 mg in a 24/4 regimen in the treatment of acne: lesion counts and investigator & subject assessments W. Koltun1 , J. Maloney2 , J. Marr3 , M. Kunz3 . 1 Medical Center for Clinical Research, 2 Cherry Creek Research Inc, 3 Bayer Schering Pharma AG Objective: To investigate the efficacy of a combined oral contraceptive (COC) comprising ethinylestradiol (EE) 20 mcg/drospirenone (drsp) 3 mg, administered in a 24/4 regimen (24 active tablets and 4 inert tablets per cycle; YAZ® ), in the treatment of moderate acne vulgaris. Methods: We pooled two identically-designed studies involving a total of 893 healthy women (aged 14–45 years) with moderate acne, randomized to receive the EE 20 mcg/drsp 3 mg COC (n = 451) or placebo (n = 442) for 6 cycles. Efficacy variables assessed included the change from baseline in papules, pustules, nodules, open comedones, and closed comedones counts, and the percentage of women showing improvement according to the Investigator’s Overall Improvement Rating and Subject’s Overall Self-assessment Rating. Results: The EE 20 mcg/drsp 3 mg 24/4 COC was associated with a significantly greater reduction in individual lesion counts from baseline to endpoint, compared with placebo (p < 0.05). There was a significantly higher odds that a woman was rated as ‘improved’ on the Investigator’s Overall Improvement Rating (odds ratio [OR] 3.84; 95% CI: 2.58, 5.80; p < 0.0001) or that she rated herself as ‘improved’ on the Subject’s Self-Assessment Rating (OR 4.14; 95% CI: 2.75, 6.37; p < 0.0001) in the EE 20 mcg/drsp 3 mg 24/4 COC group than in the placebo group. Conclusion: The EE 20 mcg/drsp 3 mg 24/4 COC is a suitable option for women with moderate acne vulgaris who require contraception. P728 Ethinylestradiol 20 mcg/drospirenone 3 mg oral contraceptive administered in 24/4 regimen in the treatment of moderate acne vulgaris: a pooled analysis of two randomized, double-blind, placebo-controlled studies W. Koltun1 , J. Maloney2 , J. Marr3 , M. Kunz3 . 1 Medical Center for Clinical Research, 2 Cherry Creek Research Inc, 3 Bayer Schering Pharma AG Objective: To investigate the effects of ethinylestradiol (EE) 20 mcg/drospirenone (drsp) 3 mg combined oral contraceptive (COC) administered in a 24/4 regimen (24 active tablets and 4 inert tablets per cycle; YAZ® ) for the treatment of moderate acne vulgaris, based on a pooled analysis of two identically-designed studies. Materials and Methods: A total of 893 healthy females (aged 14– 45 years) with moderate facial acne were randomized to receive either the EE 20 mcg/drsp 3 mg COC (n = 451) or placebo (n = 442) for six cycles, in two US-based studies. The primary outcome measures were mean percent change in acne lesion counts and the investigators’ assessment of acne (Investigator Static Global Assessment scale ratings) from baseline to end point. Results: There were significantly greater reductions in the mean percent change from baseline to end point in inflammatory, noninflammatory and total lesion counts in the EE 20 mcg/drsp 3 mg 24/4 regimen group compared with the placebo group (p < 0.0001). The odds of women in the EE 20 mcg/drsp 3 mg 24/4 regimen COC group having ‘clear’ or ‘almost clear’ skin as rated by the investigators at end point was more than three fold greater than that in the placebo group (odds ratio 3.41; 95% CI: 2.15–5.43; p < 0.0001). Conclusion: A low-dose COC containing EE 20 mcg/drsp 3 mg administered in a 24/4 regimen more effectively reduced acne