Dataset Information

Progesterone receptor modulator for emergency contraception: a randomized controlled trial.

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

SUBMITTER: Creinin MD

PROVIDER: S-EPMC2853373 | biostudies-literature | 2006 Nov

REPOSITORIES: biostudies-literature

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Progesterone receptor modulator for emergency contraception: a randomized controlled trial.

Creinin Mitchell D MD Schlaff William W Archer David F DF Wan Livia L Frezieres Ron R Thomas Michael M Rosenberg Michael M Higgins James J

Obstetrics and gynecology 20061101 5

<h4>Objective</h4>Compare the efficacy and adverse effects of CDB-2914, a new progesterone receptor modulator, to levonorgestrel for emergency contraception.<h4>Methods</h4>We performed a randomized, double-blinded noninferiority trial, enrolling healthy women seeking emergency contraception within 72 hours of unprotected intercourse. Participants were randomly assigned to receive a single dose of 50 mg of CDB-2914, plus a placebo 12 hours later or two doses of 0.75 mg of levonorgestrel taken 12 ...[more]

PMID: 17077229

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Project description:INTRODUCTION:Adolescents who seek care in the emergency department (ED) are a cohort at increased risk of unintended pregnancy. Although adolescents are interested in learning about pregnancy prevention in the ED, there is a lack of effective educational interventions in this setting. Long-acting reversible contraceptives (LARC) are highly effective and safe in teens, yet are underutilized. This study assessed contraception use among adolescents in the ED and evaluated the impact of an educational video on their interest in and uptake of LARCs. METHODS:We conducted a two-arm randomized controlled trial on a convenience sample of sexually active females 14 to 21 years old in an urban pediatric ED. Participants were randomized to an educational video or standard care. All participants completed a survey and were given an informational card about affiliated teen clinics with the option to schedule an appointment. We assessed pre-post mean differences between control and intervention participants and pre-post differences among intervention participants. Participants were followed three months after their ED visit to examine use of contraception. RESULTS:A total of 79 females were enrolled (42 control and 37 intervention). The mean age was 17 years, and most were youth of color. The proportion of participants with a prior pregnancy was 18%. Almost all participants reported wanting to avoid pregnancy, yet 18% reported not using contraception at last intercourse. At baseline, 17.7% of participants were somewhat or very interested in the intrauterine device (IUD) or implant. After watching the video, 42.3% were somewhat or very interested in the IUD and 35.7% in the implant. Among those who watched the video, there were significant increases in interest in using an IUD or implant (p<.001). Compared to controls, adolescents who watched the video were also significantly more likely to report wanting an IUD (p<0.001) or implant (p=0.002). A total of 46% were reached for follow-up. Of these, 16% had initiated a LARC method after their ED visit (p=NS). CONCLUSION:Most adolescent females in the ED want to avoid pregnancy, but are using ineffective methods of contraception. A brief educational video on LARCs was acceptable to adolescents and feasible to implement in a busy urban ED setting. Adolescents who watched the video had significantly greater interest in using LARCs, but no demonstrated change in actual adoption of contraception.

Dataset Information

Progesterone receptor modulator for emergency contraception: a randomized controlled trial.

Publications

Progesterone receptor modulator for emergency contraception: a randomized controlled trial.

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