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news.Indevus Pharmaceuticals has initiated an international phase III clinical trial of PRO 2000, the company's topical, vaginal microbicide under development for the prevention of sexually transmitted infections.
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It is hoped PRO 2000 will prove effective in tackling infections such as HIV, herpes, chlamydia and gonorrhea. The trial, which is sponsored by the Medical Research Council (UK), has opened for enrollment at clinics in Johannesburg, South Africa and the Masaka district of Uganda, and is expected to expand to additional sites in South Africa, Tanzania and Zambia.
Approximately 10,000 women will be enrolled in the trial, which is expected to last approximately three to four years and include interim analyses of safety and efficacy data conducted by an independent data safety monitoring committee.
“We believe, upon successful completion of the trials, we would be in position to file marketing applications with regulatory authorities, including a New Drug Application with the FDA. In addition to the work being done on the two trials, we have begun discussions with potential public and private sector partners for the commercialization and distribution of PRO 2000,” said Dr Cooper chairman, president and CEO of Indevus.
Each woman enrolled in this double-blind, placebo-controlled trial will be assigned at random to receive one of two PRO 2000 strengths (0.5% or 2%) or a placebo. The women will be asked to apply the study product prior to sexual intercourse. In addition, all participants will receive condoms and risk-reduction counseling. Researchers will evaluate the effectiveness of PRO 2000 relative to placebo in preventing sexually transmitted infections.