Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol®
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||A Phase II/III Multicenter, Randomized, Double-masked, Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol®|
- The Cumulative Probability of Typical-use 6 Month (183 Days) Pregnancy. [ Time Frame: 6 months ] [ Designated as safety issue: No ]Number of pregnancies in women using C31G gel for 6 months (183 days) compared to women using Conceptrol gel for the same time frame.
- Incidence of Adverse Events. [ Time Frame: The DSMB will review safety data at 3 months following 200 subjects enrolled, 3 months following 400 subject enrolled, as well as additional meetings as needed. ] [ Designated as safety issue: Yes ]Evaluated by comparing the incidence of Adverse Events (AEs) among subjects using their assigned treatment for at least one day.
|Study Start Date:||June 2004|
|Study Completion Date:||September 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel
The subject will insert one applicator of C31G prior to each episode of vaginal intercourse during her participation in the study.
Active Comparator: B
Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.
Drug: nonoxynol-9 (N-9)
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.
Approximately 85% of American women (52 million) between the ages of 15 and 44 are sexually active . Approximately two-thirds or 38 million women use some form of birth control and/or STD prevention. With growing awareness of the risk of STDs, increasing numbers of women will require contraceptive methods that provide protection against STDs in addition to providing the basic contraceptive function. Currently there is no single, reasonably effective method to achieve both ends. Condoms, both male and female, present problems of acceptability for the partners of many at-risk women and, thus, cannot be considered an effective contraceptive and STD preventive for many people. A spermicide that also has the ability to prevent transmission of STDs would be a major advance, and of tremendous value to women worldwide.
C31G is an effective spermicide with in vitro activity equal to that of N-9 . C31G has been found to be a broad-spectrum antibacterial agent in vitro or in animals, active against both gram-positive and gram-negative organisms, including chlamydia, and a range of antibiotic resistant strains. It is also active against enveloped viruses including HIV and HSV. Thus, the primary objective of the study is to determine the contraceptive efficacy of C31G vaginal gel compared to Conceptrol® Vaginal Gel. The secondary objectives are to determine the safety and acceptability of the compounds with use over a period of six months or twelve months. Additional evaluations include the incidence of urinary tract infections (UTI), bacterial vaginosis (BV) and yeast vaginitis following the use of C31G vaginal gel compared to Conceptrol® Vaginal Gel.
|United States, California|
|California Family Health Council|
|Berkeley, California, United States, 94710|
|California Family Health Council|
|Los Angeles, California, United States, 90010|
|United States, Colorado|
|University of Colorado - Advanced reproductive Medicine|
|Aurora, Colorado, United States, 80010|
|United States, Maryland|
|Johns Hopkins Bayview Medical Center|
|Baltimore, Maryland, United States, 21224|
|United States, Massachusetts|
|Bay State Medical Center|
|Springfield, Massachusetts, United States, 01199|
|United States, New York|
|New York University|
|New York, New York, United States, 10016|
|New York, New York, United States, 10032|
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45267|
|University Hospitals of Cleveland MacDonald Women's Hospital|
|Cleveland, Ohio, United States, 44106|
|The Ohio State University College of Medicine|
|Columbus, Ohio, United States, 43210|
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|United States, Pennsylvania|
|University of Pennsylvania Medical Center|
|Philadelphia, Pennsylvania, United States, 19104|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Texas|
|U.T. Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|United States, Virginia|
|Jones Institute of Reproductive Medicine, EVMS|
|Norfolk, Virginia, United States, 23507|
|Study Director:||Diana L Blithe, Ph.D.||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|