Evidence map›Paper›PMID 21099590›Full record

Trial reportObstetrics and gynecology2010

Contraceptive efficacy, acceptability, and safety of C31G and nonoxynol-9 spermicidal gels: a randomized controlled trial.

Anne E Burke, Kurt Barnhart, Jeffrey T Jensen, Mitchell D Creinin, Terri L Walsh, Livia S Wan, Carolyn Westhoff, Michael Thomas, David Archer, Hongsheng Wu and 4 more

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in Obstetrics and gynecology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00274261 (A Phase II/III Multicenter, Randomized, Double-masked, Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol®), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT00274261 phase3completednot on this map

A Phase II/III Multicenter, Randomized, Double-masked, Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol®

TypeinterventionalSponsorPremier ResearchRan2004 to 2008Enrolled1,565ConditionsPregnancyArmsC31G, nonoxynol-9 (N-9)
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Spermicide used alone for contraception.The Cochrane database of systematic reviews · 2013
    Pooled it
  3. Article
  4. Article
  5. Vaginally-delivered fast-dissolving antibody tablets (FDAT) for on-demand non-hormonal contraception and multi-purpose protection.Journal of controlled release : official journal of the Controlled Release Society · 2025
    Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Review
  14. Review
  15. Review
  16. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Anne E BurkeFrom The Johns Hopkins University School of Medicine, Baltimore, Maryland; the University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania; Oregon Health Sciences University, Portland, Oregon; California Family Health Council, Los Angeles, California; New York University, New York, NY, the University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; Columbia University College of Physicians and Surgeons, New York, NY; the University of Cincinnati School of Medicine, Cincinnati, Ohio; Eastern Virginia Medical School, Norfolk, Virginia; Health Decisions Incorporated, Chapel Hill, North Carolina; University Hospitals, MacDonald Women's Hospital, Cleveland, Ohio; the University of Colorado Health Sciences Center, Denver, Colorado; the University of Texas, Southwestern Medical School, Dallas, Texas; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.
Kurt Barnhart
Jeffrey T Jensen
Mitchell D Creinin
Terri L Walsh
Livia S Wan
Carolyn Westhoff
Michael Thomas
David Archer
Hongsheng Wu
James Liu
William Schlaff
Bruce R Carr
Diana Blithe

Funding

University of Pittsburgh Clinical and Translational Science InstituteUL1TR000005 · NCATS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2012 to 2015
$50.8M
FEMALE CONTRACEPTIVE CLINICAL TRIAL: A RANDOMIZED CONTROLLED STUDY OF-2753373IN01HD003373 · NICHD · CASE WESTERN RESERVE UNIVERSITY · PI LIU, JAMES · 2004 to 2006
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FEMALE CONTRACEPTIVE CLINICAL TRIAL: A RANDOMIZED CONTROLLED STUDY OF -2753374IN01HD003374 · NICHD · THE TRUSTEES OF COLUMBIA UNIVERSITY · PI WESTHOFF, CAROLYN · 2004 to 2006
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FEMALE CONTRACEPTIVE CLINICAL TRIAL: A RONDOMIZED CONTROLLED STUDY OF -2753375IN01HD003375 · NICHD · JOHNS HOPKINS UNIVERSITY · PI BLUMENTHAL, PAUL · 2004 to 2006
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FEMALE CONTRACEPTIVE CLINICAL TRIAL: A RANDOMIZED CONTROLLED STUDY OF -2753376IN01HD003376 · NICHD · TRUSTEES OF THE UNIVERSITY OF PENNSYLVAN · PI BARNHART, KURT T · 2004 to 2006
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FEMALE CONTRACEPTIVE CLINICAL TRIAL: A RANDOMIZED CONTROLLED STUDY OF -2753377IN01HD003377 · NICHD · UNIVERSITY OF CINCINNATI · PI THOMAS, MICHAEL · 2004 to 2006
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NICHD CONTRACEPTIVE CLINICAL TRIALS NETWORK /FEMALE CONTRACEPTIVE TRIA-2753372IN01HD003372 · NICHD · MAGEE-WOMENS HEALTH CORPORATION · PI CREININ, MITCHELL D · 2004 to 2006
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FEMALE CONTRACEPTIVE CLINICAL TRIAL: A RANDOMIZED CONTROLLED STUDY OF -2753379IN01HD003379 · NICHD · NEW YORK UNIVERSITY · PI WAN, LIVIA B · 2004 to 2006
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FEMALE CONTRACEPTIVE CLINICAL TRIAL: A RANDOMIZED CONTROLLED STUDY OF -2753380IN01HD003380 · NICHD · THE UNIVERSITY OF TEXAS SOUTHWESTERN MED · PI STUART, GRETCHEN · 2004 to 2006
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FEMALE CONTRACEPTIVE CLINICAL TRIAL: A RANDOMIZED CONTROLLED STUDY OF -2753381IN01HD003381 · NICHD · CALIFORNIA FAMILY HEALTH COUNCIL. INC. · PI NELSON, ANITA · 2004 to 2006
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FEMALE CONTRACEPTIVE CLINICAL TRIAL: A RANDOMIZED CONTROLLED STUDY OF -2753382IN01HD003382 · NICHD · EASTERN VIRGINIA MEDICAL SCHOOL · PI ARCHER, DAVID · 2004 to 2006
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CORE TASK /FEMALE TOPIC AREA/: PROTOCOL REVIEW. PROTOCOL DEVELOPMENT. -2753378IN01HD003378 · NICHD · OREGON HEALTH AND SCIENCE UNIVERSITY · PI JENSEN, JEFFREY · 2004 to 2006
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NCATS NIH HHS UL1 TR000005NICHD NIH HHS N01 HD003372NICHD NIH HHS N01 HD003373NICHD NIH HHS N01 HD003374NICHD NIH HHS N01 HD003375NICHD NIH HHS N01 HD003376NICHD NIH HHS N01 HD003377NICHD NIH HHS N01 HD003378NICHD NIH HHS N01 HD003379NICHD NIH HHS N01 HD003380NICHD NIH HHS N01 HD003381NICHD NIH HHS N01 HD003382
6 · The paper itself

Abstract

objectiveTo estimate whether a gel containing the spermicide C31G was noninferior to a commercially available product containing nonoxynol-9.

methodsParticipants were healthy, sexually active women aged 18-40 years. Measured outcomes included pregnancy rates, continuation rates, adverse events, and acceptability. The primary study outcome was contraceptive efficacy. Sample size was calculated at a 2.5% significance level using a one-sided test based on assumed 6-month pregnancy probability of 15% in the nonoxynol-9 group. Sample size was sufficient to reject, with 80% power, the null hypothesis that pregnancy probability in the C31G arm would be more than 5% higher.

resultsNine hundred thirty-two women were randomized in the C31G group and 633 in the nonoxynol-9 group. For randomized patients with at least one episode of coitus (modified intent-to-treat group), 6-month pregnancy probabilities were 12.0% (95% confidence interval [CI] 9.3-14.7%) and 12.0% (95% CI 8.7-15.3%) for C31G and nonoxynol-9,respectively. Twelve-month pregnancy probabilities were 13.8% (95% CI 7.6-20%) for C31G and 19.8% (95% CI 10.9-28.7%) for nonoxynol-9. Two serious adverse events were deemed possibly related to study product and neither occurred in the C31G group. Three fourths of users in either group reported that they liked their assigned study product. Approximately 40% of patients discontinued prematurely for reasons other than pregnancy with 11% lost to follow-up.

conclusionC31G demonstrated noninferior contraceptive efficacy compared with nonoxynol-9. C31G may provide another marketable option for women seeking spermicidal contraception. CLINICAL

trial registrationClinicalTrials.gov, www.ClinicalTrials.gov, NCT00274261.

Indexed as

Fatty Acids, UnsaturatedNonoxynolSpermatocidal AgentsAdolescentAdultBetaineDouble-Blind MethodFemaleGelsHumansPregnancyYoung AdultBetaineC 31GFatty Acids, UnsaturatedGelsNonoxynolSpermatocidal Agents

Identifiers

PMID21099590
PMCPMC3332092

What OpenQuestion holds

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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.