Document Detail


Contraceptive efficacy, acceptability, and safety of C31G and nonoxynol-9 spermicidal gels: a randomized controlled trial.
MedLine Citation:
PMID:  21099590     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To estimate whether a gel containing the spermicide C31G was noninferior to a commercially available product containing nonoxynol-9.
METHODS: Participants 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.
RESULTS: Nine 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.
CONCLUSION: C31G demonstrated noninferior contraceptive efficacy compared with nonoxynol-9. C31G may provide another marketable option for women seeking spermicidal contraception.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.ClinicalTrials.gov, NCT00274261.
Authors:
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; James Liu; William Schlaff; Bruce R Carr; Diana Blithe
Publication Detail:
Type:  Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Obstetrics and gynecology     Volume:  116     ISSN:  1873-233X     ISO Abbreviation:  Obstet Gynecol     Publication Date:  2010 Dec 
Date Detail:
Created Date:  2010-11-24     Completed Date:  2011-01-04     Revised Date:  2013-07-03    
Medline Journal Info:
Nlm Unique ID:  0401101     Medline TA:  Obstet Gynecol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1265-73     Citation Subset:  AIM; IM    
Affiliation:
The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00274261
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Betaine / adverse effects,  analogs & derivatives*
Double-Blind Method
Fatty Acids, Unsaturated* / adverse effects
Female
Gels
Humans
Nonoxynol* / adverse effects
Pregnancy
Spermatocidal Agents* / adverse effects
Young Adult
Grant Support
ID/Acronym/Agency:
N01 HD003372/HD/NICHD NIH HHS; N01 HD003373/HD/NICHD NIH HHS; N01 HD003374/HD/NICHD NIH HHS; N01 HD003375/HD/NICHD NIH HHS; N01 HD003376/HD/NICHD NIH HHS; N01 HD003377/HD/NICHD NIH HHS; N01 HD003378/HD/NICHD NIH HHS; N01 HD003379/HD/NICHD NIH HHS; N01 HD003380/HD/NICHD NIH HHS; N01 HD003381/HD/NICHD NIH HHS; N01 HD003382/HD/NICHD NIH HHS
Chemical
Reg. No./Substance:
0/Fatty Acids, Unsaturated; 0/Gels; 0/Spermatocidal Agents; 107-43-7/Betaine; 26027-38-3/Nonoxynol; 86903-77-7/C 31G
Comments/Corrections

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