EVALUATION OF A 24 HOUR MICROBICIDE VAGINAL SUPPOSITORY

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BIOTEK developed under NICHD Contract N01-HD-l2829 and SBIR Grant No. 2R44HD28387-02, a bioerodible contraceptive suppository which delivers an immediate dose of the spermicide nonoxynol-9 within one minute after insertion, followed by a sustained dose of nonoxynol-9 for a period of 24 hours. The suppository has been extensively tested in vitro, ex vivo with both rabbit and human semen, in vivo in rabbits, and clinically on 14 women using postcoital tests (PCT) in which the suppository was inserted l2 hours before intercourse. The PCT tests were conducted at two clinical centers. None of the l4 women showed any live sperm in the vagina in the 12 hour PCT test. Details of the in vitro, ex vivo, in vivo and clinical tests are presented in the proposal. The data to date shows that the composite suppository is effective for a period of at least l2 hours. Evaluation of its performance beyond this period is currently underway in a PCT study in which the suppository is inserted 24 hours before intercourse. The results of this study will not become available for six to nine months. Given the fact that nonoxynol-9 is effective both as a spermicide and microbicide against sexually transmitted diseases (STD's), support is sought for a Phase I study to test the efficacy of the suppository as a microbicide. Specifically, we would like to test its ability to inactivate STD pathogens with the time of pretreatment extended over periods up to 12 hours following insertion into the vagina. These tests will be conducted in an animal model developed by Dr, Nigel Bourne and Dr. David Bernstein at the Children's Hospital Medical Center, Cincinnati, Ohio. The animal models are: the guinea pig model of genital herpes simplex virus (HSV-2) and the guinea pig chlamidyal infection model. PROPOSED COMMERCIAL APPLICATIONS: It is currently estimated that 10 million people have genital HSV-2 infections and 500,000 new cases are identified yearly. The most common STD in the U.S. is chlamydiosis which can lead to a number of serious complications. There is an urgent need for an unobtrusive method by which a woman can protect herself against STD's without active cooperation of her male partner. Thus, it is clear that the potential market for a product that will protect against STD's is very significant.