Progesterone Receptor Modulator for Emergency Contraception A Randomized Controlled Trial

摘要: OBJECTIVE: Compare the efficacy and adverse effects of CDB-2914, a new progesterone receptor modulator, to levonorgestrel for emergency contraception. METHODS: We performed randomized, doubleblinded noninferiority trial, enrolling healthy women seeking contraception within 72 hours unprotected intercourse. Participants were randomly assigned receive single dose 50 mg plus placebo 12 later or two doses 0.75 taken apart. Follow-up was scheduled 5 7 days after expected onset next menstrual period. Posttreatment pregnancy established by positive urine test at follow-up confirmed quantitative serum -hCG. Daily diaries used from time use until menses record sexual activity. RESULTS: Product evaluable in 775 CDB2914 users 774 users. Pregnancies occurred (0.9%, 95% confidence interval 0.2–1.6%) 13 (1.7%, 0.8–2.6%) women, respectively. Based on estimated cycle day intercourse, 85% 69% anticipated pregnancies, respectively, averted. Nausea reported somewhat greater percentage CDB-2914 than (29% compared with 24%, P.03), but distribution other similar both groups. Women groups experienced considerable variation length as their individual normal lengths. CONCLUSION: is least effective preventing pregnancies intercourse has side effect profile. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www. clinicaltrials.gov, NCT00271583 (Obstet Gynecol 2006;108:1089–97) LEVEL OF EVIDENCE: I