Indevus Pharmaceuticals today announced that it has initiated its Phase II proof of concept trial for pagoclone in premature ejaculation. The trial is designed to evaluate the efficacy of various doses of pagoclone versus placebo in delaying the ejaculatory response in male patients with primary premature ejaculation.
The trial is expected to enroll approximately 100 patients at multiple sites in the U.S. Patients will be evaluated for a total of nine weeks including a four-week screening phase and a five-week treatment phase. The company anticipates announcing results of the trial in early 2007.