Pregnancy Clinical Trial
Official title:
A Phase II/III Multicenter, Randomized, Double-masked, 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.
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.
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