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DMPA-SC 104 has significantly less impact on bone mineral density than leuprolide acetate in patients with endometriosis
Abstracts / Contraception 72 (2005) 229 –245
26 DECISION ANALYSIS OF IMMEDIATE VS. DELAYED INSERTION OF INTRAUTERINE DEVICES AFTER ABORTION TO PREVENT PREGNANCY Reeves MF, Smith KJ, Creinin MD. Introduction: Immediate postabortal intrauterine device (IUD) insertion has been shown to be safe and effective, yet it is not commonly available. Materials and Methods: We performed a decision analysis to examine pregnancy rates at 1 year following abortion with immediate or delayed IUD insertion. The base case assumed an 80% 1-year continuation rate for both groups, an additional 10% expulsion risk with immediate insertion, a 30% risk for not returning for delayed insertion, and pregnancy rates of 8% without an IUD and 0.5% with an IUD. Pregnancy between abortion and delayed IUD insertion was not considered. One-way, two-way and Monte Carlo sensitivity analyses were performed. Results: In the decision model, the 12-month pregnancy rate was 20 per 1000 women in the immediate-insertion group and 33 per 1000 women in the delayed-insertion group. Sensitivity analyses show the model to be dependent on the expulsion rate in the immediate-insertion group (varied up to 30%) and the rate of not returning in the delayed-insertion group. Analysis of multiple scenarios showed that immediate insertion results in fewer pregnancies 83% of the time, with an absolute difference in pregnancy rate of 1%. If the expulsion rate is less than 10%, immediate insertion is favored in 99.5% of scenarios. Conclusion: Despite assumptions in the model heavily favoring delayed insertion, immediate postabortal IUD insertion is predicted to result in 13 fewer pregnancies per 1000 women in the following year than delayed insertion. Future research should examine costeffectiveness and nonpregnancy outcomes. 27 DMPA-SC 104 HAS SIGNIFICANTLY LESS IMPACT ON BONE MINERAL DENSITY THAN LEUPROLIDE ACETATE IN PATIENTS WITH ENDOMETRIOSIS Archer DF, Gallagher JC. Introduction: Bone mineral density (BMD) loss is a clinical problem following hypoestrogenic therapy for endometriosisassociated pain. Materials and Methods: An evaluator-blinded, comparatorcontrolled, North American trial evaluated 6 months’ treatment with depot medroxyprogesterone acetate subcutaneous injection 104 mg/0.65 ml (DMPA-SC 104) or intramuscular leuprolide 11.25 mg administered every 3 months, with 12 months’ post-treatment follow-up. Subjects were premenopausal women aged 18 to 49 years with recently diagnosed, persistent or recurrent endometriosis. Results: Lumbar spine BMD decreased significantly less after treatment with DMPA-SC 104 (n = 77) compared with leuprolide (n = 98) at month 6 (median percent change, 1.10% vs. 3.95%; p b .001) and at month 18 [+0.20% (n = 31) vs. 1.70% (n = 42); p = .021]. At month 6, losses of 2.5% to 4.9% occurred in 21% of DMPA-SC 104 vs. 42% of leuprolide patients. Losses larger than 5.0% occurred in only 4% of DMPA-SC 104 vs. 35% of leuprolide patients. Total hip also decreased significantly less after treatment with DMPA-SC 104 (n = 77) compared with leuprolide (n = 98) at month 6 (median percent change, 0.30% vs. 1.65%;
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p b .001) and at month 18 [0% (n = 32) vs. 1.30% (n = 42); p = .004]. At month 6, losses of 2.5% to 4.9% occurred in 9% of DMPA-SC 104 vs. 25% of leuprolide patients. Losses larger than 5.0% occurred in zero DMPA-SC 104 patients vs. 10% of leuprolide patients. Conclusion: Treatment with DMPA -SC 104 is associated with less impact on BMD vs. leuprolide treatment. On average, patients receiving DMPA-SC 104 returned to baseline BMD values at both the lumbar spine and hip 12 months after completing therapy. 28 HYSTEROSCOPIC STERILIZATION: LONG-TERM SAFETY AND EFFICACY Valle RF. Introduction: The goal of the study was to assess the long-term safety and efficacy of hysteroscopic sterilization. Materials and Methods: The Essure micro-insert (Conceptus Inc., San Carlos, CA) was placed into the proximal segment of at least one fallopian tube lumen of 682 women in the prospective, multicenter, international Phase II and Pivotal clinical trials. Successful bilateral device placement was achieved in 643 (94%) women. After confirmation of tubal occlusion by hysterosalpingogram, they began relying on the micro-inserts for contraception. These women continue to be assessed at 1-, 2-, 3-, 4 - and 5-year intervals. Results: As of December 16, 2004, 643 women contributed effectiveness time, 194 in the Phase II study and 449 in the Pivotal trial. In total, the 643 trial participants contributed 29 357 months of follow-up time without pregnancy. The average duration of reliance on this method for permanent contraception was 52.9 months for Phase II subjects and 42.5 months for women in the Pivotal trial. To date, there have been no long-term adverse events found by the investigators to be directly related to the microinsert or placement procedure. Conclusion: These findings indicate that this nonincisional method of hysteroscopic sterilization can be performed without general anesthesia and has acceptable long-term safety and contraceptive efficacy. 29 INCREASING WOMEN’S CHOICE AND ACCESS TO SAFE ABORTION SERVICES IN TURKEY: A STUDY OF THE EFFICACY AND ACCEPTABILITY OF MEDICAL ABORTION IN FOUR SITES Akin A, Dabash R, Dilbaz B, Dursun P, Aktun H, Gokkurt S, Dogan B, Winikoff B. Introduction: Integrating the choice of medical abortion can increase women’s access to and satisfaction with safe abortion services. Materials and Methods: From November 2004 through March 2005, women seeking an abortion with gestations less than 56 days LMP were given the choice of a medical abortion as an alternative to surgical evacuation at four health facilities in Ankara, Turkey. A total of 200 eligible consenting women were given 200 mg oral Mifepristone at the clinic followed by 400 Ag oral misoprostol. All women were given the choice of route (oral or sublingual) and location (home or clinic) of misoprostol administration.
26 DECISION ANALYSIS OF IMMEDIATE VS. DELAYED INSERTION OF INTRAUTERINE DEVICES AFTER ABORTION TO PREVENT PREGNANCY Reeves MF, Smith KJ, Creinin MD. Introduction: Immediate postabortal intrauterine device (IUD) insertion has been shown to be safe and effective, yet it is not commonly available. Materials and Methods: We performed a decision analysis to examine pregnancy rates at 1 year following abortion with immediate or delayed IUD insertion. The base case assumed an 80% 1-year continuation rate for both groups, an additional 10% expulsion risk with immediate insertion, a 30% risk for not returning for delayed insertion, and pregnancy rates of 8% without an IUD and 0.5% with an IUD. Pregnancy between abortion and delayed IUD insertion was not considered. One-way, two-way and Monte Carlo sensitivity analyses were performed. Results: In the decision model, the 12-month pregnancy rate was 20 per 1000 women in the immediate-insertion group and 33 per 1000 women in the delayed-insertion group. Sensitivity analyses show the model to be dependent on the expulsion rate in the immediate-insertion group (varied up to 30%) and the rate of not returning in the delayed-insertion group. Analysis of multiple scenarios showed that immediate insertion results in fewer pregnancies 83% of the time, with an absolute difference in pregnancy rate of 1%. If the expulsion rate is less than 10%, immediate insertion is favored in 99.5% of scenarios. Conclusion: Despite assumptions in the model heavily favoring delayed insertion, immediate postabortal IUD insertion is predicted to result in 13 fewer pregnancies per 1000 women in the following year than delayed insertion. Future research should examine costeffectiveness and nonpregnancy outcomes. 27 DMPA-SC 104 HAS SIGNIFICANTLY LESS IMPACT ON BONE MINERAL DENSITY THAN LEUPROLIDE ACETATE IN PATIENTS WITH ENDOMETRIOSIS Archer DF, Gallagher JC. Introduction: Bone mineral density (BMD) loss is a clinical problem following hypoestrogenic therapy for endometriosisassociated pain. Materials and Methods: An evaluator-blinded, comparatorcontrolled, North American trial evaluated 6 months’ treatment with depot medroxyprogesterone acetate subcutaneous injection 104 mg/0.65 ml (DMPA-SC 104) or intramuscular leuprolide 11.25 mg administered every 3 months, with 12 months’ post-treatment follow-up. Subjects were premenopausal women aged 18 to 49 years with recently diagnosed, persistent or recurrent endometriosis. Results: Lumbar spine BMD decreased significantly less after treatment with DMPA-SC 104 (n = 77) compared with leuprolide (n = 98) at month 6 (median percent change, 1.10% vs. 3.95%; p b .001) and at month 18 [+0.20% (n = 31) vs. 1.70% (n = 42); p = .021]. At month 6, losses of 2.5% to 4.9% occurred in 21% of DMPA-SC 104 vs. 42% of leuprolide patients. Losses larger than 5.0% occurred in only 4% of DMPA-SC 104 vs. 35% of leuprolide patients. Total hip also decreased significantly less after treatment with DMPA-SC 104 (n = 77) compared with leuprolide (n = 98) at month 6 (median percent change, 0.30% vs. 1.65%;
237
p b .001) and at month 18 [0% (n = 32) vs. 1.30% (n = 42); p = .004]. At month 6, losses of 2.5% to 4.9% occurred in 9% of DMPA-SC 104 vs. 25% of leuprolide patients. Losses larger than 5.0% occurred in zero DMPA-SC 104 patients vs. 10% of leuprolide patients. Conclusion: Treatment with DMPA -SC 104 is associated with less impact on BMD vs. leuprolide treatment. On average, patients receiving DMPA-SC 104 returned to baseline BMD values at both the lumbar spine and hip 12 months after completing therapy. 28 HYSTEROSCOPIC STERILIZATION: LONG-TERM SAFETY AND EFFICACY Valle RF. Introduction: The goal of the study was to assess the long-term safety and efficacy of hysteroscopic sterilization. Materials and Methods: The Essure micro-insert (Conceptus Inc., San Carlos, CA) was placed into the proximal segment of at least one fallopian tube lumen of 682 women in the prospective, multicenter, international Phase II and Pivotal clinical trials. Successful bilateral device placement was achieved in 643 (94%) women. After confirmation of tubal occlusion by hysterosalpingogram, they began relying on the micro-inserts for contraception. These women continue to be assessed at 1-, 2-, 3-, 4 - and 5-year intervals. Results: As of December 16, 2004, 643 women contributed effectiveness time, 194 in the Phase II study and 449 in the Pivotal trial. In total, the 643 trial participants contributed 29 357 months of follow-up time without pregnancy. The average duration of reliance on this method for permanent contraception was 52.9 months for Phase II subjects and 42.5 months for women in the Pivotal trial. To date, there have been no long-term adverse events found by the investigators to be directly related to the microinsert or placement procedure. Conclusion: These findings indicate that this nonincisional method of hysteroscopic sterilization can be performed without general anesthesia and has acceptable long-term safety and contraceptive efficacy. 29 INCREASING WOMEN’S CHOICE AND ACCESS TO SAFE ABORTION SERVICES IN TURKEY: A STUDY OF THE EFFICACY AND ACCEPTABILITY OF MEDICAL ABORTION IN FOUR SITES Akin A, Dabash R, Dilbaz B, Dursun P, Aktun H, Gokkurt S, Dogan B, Winikoff B. Introduction: Integrating the choice of medical abortion can increase women’s access to and satisfaction with safe abortion services. Materials and Methods: From November 2004 through March 2005, women seeking an abortion with gestations less than 56 days LMP were given the choice of a medical abortion as an alternative to surgical evacuation at four health facilities in Ankara, Turkey. A total of 200 eligible consenting women were given 200 mg oral Mifepristone at the clinic followed by 400 Ag oral misoprostol. All women were given the choice of route (oral or sublingual) and location (home or clinic) of misoprostol administration.