Progesterone receptor modulator for emergency contraception: A randomized controlled trial

Mitchell D Creinin, William Schlaff, David F. Archer, Livia Wan, Ron Frezieres, Michael Thomas, Michael Rosenberg, James Higgins

Research output: Contribution to journalArticle

187 Citations (Scopus)

Abstract

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 β-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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00271583.

Original languageEnglish (US)
Pages (from-to)1089-1097
Number of pages9
JournalObstetrics and Gynecology
Volume108
Issue number5
DOIs
StatePublished - Nov 2006
Externally publishedYes

Fingerprint

Postcoital Contraception
Levonorgestrel
Progesterone Receptors
Randomized Controlled Trials
Pregnancy
Confidence Intervals
Menstruation
Menstrual Cycle
Sexual Behavior
Nausea
Placebos
ulipristal
Clinical Trials
Urine
Serum

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Progesterone receptor modulator for emergency contraception : A randomized controlled trial. / Creinin, Mitchell D; Schlaff, William; Archer, David F.; Wan, Livia; Frezieres, Ron; Thomas, Michael; Rosenberg, Michael; Higgins, James.

In: Obstetrics and Gynecology, Vol. 108, No. 5, 11.2006, p. 1089-1097.

Research output: Contribution to journalArticle

Creinin, MD, Schlaff, W, Archer, DF, Wan, L, Frezieres, R, Thomas, M, Rosenberg, M & Higgins, J 2006, 'Progesterone receptor modulator for emergency contraception: A randomized controlled trial', Obstetrics and Gynecology, vol. 108, no. 5, pp. 1089-1097. https://doi.org/10.1097/01.AOG.0000239440.02284.45
Creinin, Mitchell D ; Schlaff, William ; Archer, David F. ; Wan, Livia ; Frezieres, Ron ; Thomas, Michael ; Rosenberg, Michael ; Higgins, James. / Progesterone receptor modulator for emergency contraception : A randomized controlled trial. In: Obstetrics and Gynecology. 2006 ; Vol. 108, No. 5. pp. 1089-1097.
@article{7202d5c42b6743548bd54c94e95e4359,
title = "Progesterone receptor modulator for emergency contraception: A randomized controlled trial",
abstract = "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 β-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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00271583.",
author = "Creinin, {Mitchell D} and William Schlaff and Archer, {David F.} and Livia Wan and Ron Frezieres and Michael Thomas and Michael Rosenberg and James Higgins",
year = "2006",
month = "11",
doi = "10.1097/01.AOG.0000239440.02284.45",
language = "English (US)",
volume = "108",
pages = "1089--1097",
journal = "Obstetrics and Gynecology",
issn = "0029-7844",
publisher = "Lippincott Williams and Wilkins",
number = "5",

}

TY - JOUR

T1 - Progesterone receptor modulator for emergency contraception

T2 - A randomized controlled trial

AU - Creinin, Mitchell D

AU - Schlaff, William

AU - Archer, David F.

AU - Wan, Livia

AU - Frezieres, Ron

AU - Thomas, Michael

AU - Rosenberg, Michael

AU - Higgins, James

PY - 2006/11

Y1 - 2006/11

N2 - 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 β-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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00271583.

AB - 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 β-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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00271583.

UR - http://www.scopus.com/inward/record.url?scp=33750512155&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33750512155&partnerID=8YFLogxK

U2 - 10.1097/01.AOG.0000239440.02284.45

DO - 10.1097/01.AOG.0000239440.02284.45

M3 - Article

C2 - 17077229

AN - SCOPUS:33750512155

VL - 108

SP - 1089

EP - 1097

JO - Obstetrics and Gynecology

JF - Obstetrics and Gynecology

SN - 0029-7844

IS - 5

ER -