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

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

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

OBJECTIVE: Compare the efficacy and adverse effects of CDB-2914, a new progesterone receptor modulator, to levonorgestrel for emergency contraception. METHODS: 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. RESULTS: 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. CONCLUSION: CDB-2914 is at least as effective as levonorgestrel in preventing pregnancies after unprotected intercourse and has a similar side effect profile. LEVEL OF EVIDENCE: I.

Progesterone receptor modulator for emergency contraception: a randomized controlled trial. Publishing Authors By Initials

For similar investigative techniques: epidemiologic methods: data collection: vital statistics: pregnancy rate research abstracts see: investigative techniques: epidemiologic methods: data collection: vital statistics: pregnancy rate research

PUBMED ID PMID:

MEDLINE DATE:

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

PUBLICATION TYPE: Research Support, N.I.H., Extr

Journal: Obstetrics and gynecology

VOLUME: 108

Page Numbers: 1089-97

Journal Abbreviation:

ISSN: 0029-7844

DAY: 3

MONTH: Nov

YEAR: 2006

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

Number of References:

LANGUAGE: eng

NlmUniqueID: 401101

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

KEYWORDS: Pregnancy Rate

MESH TERMS: therapeutic use

Chemical & Substance for Abstract: Progesterone receptor modulator for emergency contraception: a randomized controlled trial. Information

Substance Name: Levonorgestrel

Registry Number: 797-63-7

Grant and Affiliation Information for Progesterone receptor modulator for emergency contraception: a randomized controlled trial.

AFFILIATION: Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh and Magee-Womens Research Institute, Pittsburgh, Pennsylvania 15213, USA. creinin@upmc.edu

Country: United States

AGENCY: United States NICHD

GRANT: N01-HD-9–3297

ACRONYM: HD

MEDLINETA: Obstet Gynecol

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