CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,565 enrolled
Drug / intervention
C31G +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00274261
NCT00274261Phase 3Completed
CompareCT.gov

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

Premier Research·interventional·Posted Jan 10, 2006·Updated May 1, 2018

In Brief

A Phase 3 clinical trial evaluating C31G and nonoxynol-9 (N-9) for Pregnancy. Completed, enrolled 1,565 participants across 15 sites.

Detailed Summary

This is a multicenter, randomized, double-masked, controlled, phase III study of repeated use of C31G vaginal gel compared to Conceptrol® Vaginal Gel as the primary method of contraception over six months (183 days) and at least six cycles of use. In addition, there is an opportunity for subjects to continue with study treatment for up to twelve months (365 days) and twelve cycles of treatment upon completion of the first six months of treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPregnancy
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 10, 2006
Enrollment StartJun 1, 2004
Primary CompletionJul 1, 2008
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 20.5 years ago

Interventions

C31Gdrug

The subject will insert one applicator of C31G prior to each episode of vaginal intercourse during her participation in the study.

nonoxynol-9 (N-9)drug

The subject will insert one applicator of Conceptrol® vaginal gel (nonoxynol-9) prior to each episode of vaginal intercourse during her participation in the study.