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Phase II clinical trial data presented on topical alprostadil.
2004 NOV 22 - (NewsRx.com & NewsRx.net) -- Vivus Inc. (Nasdaq:VVUS) investigators presented positive results of a Phase II clinical study evaluating the safety and efficacy of the company's product Alista (topical alprostadil) for the treatment of female sexual arousal disorder (FSAD) in premenopausal women.
The data were reported at the Annual Meeting of the International Society for the Study of Women's Sexual Health (ISSWSH). Stephanie Kuffel, PhD, acting instructor, Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, presented the findings on October 30, 2004.
Kuffel provided a detailed analysis of previously announced results of a double-blind, placebo-controlled, crossover-design study that evaluated the response to Alista administered at home by 51 premenopausal women diagnosed with FSAD.
The study demonstrated that treatment with Alista significantly increased the number of successful and satisfactory sexual events by 48% over placebo (p
Additionally, and as reported earlier, the study showed that 64% of Alista doses resulted in satisfactory sexual events (p
"Female sexual arousal disorder is a common yet largely under treated condition," said Kuffel. "These results with Alista appear encouraging for the treatment of premenopausal women with FSAD. We are hopeful that this work, coupled with additional clinical studies, will lead to a greater understanding of FSAD and the availability of effective treatments for women who are impacted by this condition."
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Source: HighBeam Research, Phase II clinical trial data presented on topical alprostadil.