Conditions: Pregnancy
Keywords: contraception
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1565
Healthy volunteers: yes

Brief 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.

Detailed description:
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.

Arms:
arm 1: C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel arm 2: Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.

Interventions: intervention 1: C31G intervention 2: nonoxynol-9 (N-9)
Intervention descriptions: intervention 1: The subject will insert one applicator of C31G prior to each episode of vaginal intercourse during her participation in the study. intervention 2: 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.

Protocol document: