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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00274261 |
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.
Condition | Intervention | Phase |
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Pregnancy |
Drug: C31G Drug: nonoxynol-9 (N-9) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II/III Multicenter, Randomized, Double-Masked, Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol® |
Estimated Enrollment: | 1680 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel
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Drug: C31G
The subject will insert one applicator of C31G prior to each episode of vaginal intercourse during her participation in the study.
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B: Active Comparator
Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
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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.
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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.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Potential subjects must:
Exclusion Criteria:
Potential subjects must not:
United States, California | |
California Family Health Council | |
Los Angeles, California, United States, 90010 | |
California Family Health Council | |
Berkeley, California, United States, 94710 | |
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 | |
Columbia University | |
New York, New York, United States, 10032 | |
United States, Ohio | |
University of Cincinnati | |
Cincinnati, Ohio, United States, 45267 | |
The Ohio State University College of Medicine | |
Columbus, Ohio, United States, 43210 | |
University Hospitals of Cleveland MacDonald Women's Hospital | |
Cleveland, Ohio, United States, 44106 | |
United States, Oregon | |
Oregon Health & Science University | |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 | |
University of Pennsylvania Medical Center | |
Philadelphia, Pennsylvania, United States, 19104 | |
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) |
Responsible Party: | National Institute of Child Health and Human Development ( Diana L Blithe, Ph.D., Study Director ) |
Study ID Numbers: | HHSN27500002, HHSN2752004033661 |
Study First Received: | January 6, 2006 |
Last Updated: | June 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00274261 History of Changes |
Health Authority: | United States: Food and Drug Administration |
contraception |
Nonoxynol Octoxynol Contraceptive Agents Contraceptive Agents, Female Contraceptive Agents, Male |
Nonoxynol Octoxynol Contraceptive Agents Therapeutic Uses Physiological Effects of Drugs Contraceptive Agents, Female |
Antispermatogenic Agents Reproductive Control Agents Contraceptive Agents, Male Spermatocidal Agents Pharmacologic Actions |