Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol®

Phase 3 Completed 1565 enrolled Premier Research Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab

RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start: 2004-06
Primary completion: 2008-07
Completion: 2008-09

Outcome

Met primary endpoint

paper C31G demonstrated noninferior contraceptive efficacy compared with nonoxynol-9. PMID 21099590 ↗

Publications

Burke AE, Barnhart K, Jensen JT, Creinin MD, Walsh TL, Wan LS, Westhoff C, Thomas M, Archer D, Wu H, Liu J, Schlaff W, Carr BR, Blithe D. Contraceptive efficacy, acceptability, and safety of C31G and nonoxynol-9 spermicidal gels: a randomized controlled trial. Obstet Gynecol. 2010 Dec;116(6):1265-1273. doi: 10.1097/AOG.0b013e3181fc3b1a.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	C31G	Unknown	35 mg	Other
Comparator	nonoxynol-9 (N-9)	Unknown	100 mg	Other