Evidence map›Paper›PMID 17077229›Full record

Trial reportObstetrics and gynecology2006

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

Registry-linked trialOpen access · greenAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Obstetrics and gynecology, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00271583 (A Prospective, Randomized, Double Blind, Multicenter Study to Compare the Efficacy, Safety and Tolerance of CDB-2914 With Levonorgestrel as Emergency Contraception), which is not on this map. Cited by 51 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 6 pooled it
7.7field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00271583 phase2 / phase3completednot on this map

A Prospective, Randomized, Double Blind, Multicenter Study to Compare the Efficacy, Safety and Tolerance of CDB-2914 With Levonorgestrel as Emergency Contraception

TypeinterventionalSponsorUniversity of PittsburghRan1999 to 2001Enrolled1,672ConditionsEmergency ContraceptionArmsCDB-2914, levonorgestrel
3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 6 syntheses or guidelines pooled it, 231 citations in OpenAlex.

  1. U.S. Selected Practice Recommendations for Contraceptive Use, 2024.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2024
    Guideline
  2. Pooled it
  3. Interventions for emergency contraception.The Cochrane database of systematic reviews · 2019
    Pooled it
  4. Interventions for emergency contraception.The Cochrane database of systematic reviews · 2017
    Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Trial
  10. Observational
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. Article
  20. Development of a Novel Computerized Clinical Decision Support System to Improve Adolescent Sexual Health Care Provision.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2019
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Mitchell D CreininDepartment of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh and Magee-Womens Research Institute, Pittsburgh, Pennsylvania 15213, USA. creinin@upmc.edu
William Schlaff
David F Archer
Livia Wan
Ron Frezieres
Michael Thomas
Michael Rosenberg
James Higgins
Magee-Womens Research Institute · US

Funding

ZOPOLRESTAT IN SUBJECTS W/ PERIPHERAL SYMMETRICAL DIABETIC POLYNEUROPATHYM01RR000096 · NCRR · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI NOVIK, YELENA · 1985 to 2008
$34.8M
WITHIN SUBJ VARIABILITY IN MEASUREMENTS DRUG METABOL ENZYMES IN HLTY SUBJM01RR000056 · NCRR · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI LEVINE, ARTHUR S · 1985 to 2006
$29.2M
PHASE II STUDY TO COMPARE CDB-2914 AND LEVONORGESTREL-275993297N01HD093297 · NICHD · UNIVERSITY OF CINCINNATI · 1999 to 2003
$40k
STATISTICAL AND CLINICAL COORDINATING CENTER-275963261N01HD063261 · NICHD · HEALTH DECISIONS, INC. · 1996 to 2003
–
NCRR NIH HHS M01 RR000056NCRR NIH HHS M01 RR000096NCRR NIH HHS M01RR00096NCRR NIH HHS MO1RR000056NICHD NIH HHS N01-HD-6-3261NICHD NIH HHS N01-HD-9-3297
6 · The paper itself

Abstract

objectiveCompare the efficacy and adverse effects of CDB-2914, a new progesterone receptor modulator, to levonorgestrel for emergency contraception.

methodsWe 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.

resultsProduct 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.

conclusionCDB-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.

Indexed as

AdolescentAdultContraceptives, PostcoitalDouble-Blind MethodFemaleHumansLevonorgestrelNorpregnadienesPregnancyPregnancy RateContraceptives, PostcoitalLevonorgestrelNorpregnadienesulipristal

Identifiers

PMID17077229
PMCPMC2853373
OpenAlexW2148686723

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.