Register for Positive phase 2 results reported for Alista in premenopausal women with FSAD
Women's HealthAugust 9, 2004
2004 AUG 9 - (NewsRx.com & NewsRx.net) -- VIVUS, Inc. (VVUS) announced that data from a recently completed phase 2 clinical trial demonstrated that Alista significantly increased the percentage of satisfying sexual events in premenopausal women with female sexual arousal disorder (FSAD) when compared with placebo.
Sixty-four percent of Alista doses resulted in satisfying sexual events (p<0.05). The study also showed patients experienced an increase in the total number of satisfying sexual encounters when compared to placebo (p=3D0.05).
This double-blind, randomized, placebo-controlled, crossover study evaluated the efficacy and safety of ALISTA for premenopausal women in the home setting. In this study, involving 6 different sites, 36 women received at least one dose each of the placebo and active drug.
Women rated ALISTA as providing an increase in their level of sexual arousal (p<0.01) and a decrease in level of distress (p<0.05) when compared to placebo. Sexual arousal was evaluated through the use of a daily diary and level of distress was evaluated through the use of an industry standard questionnaire.
VIVUS is entering phase 3 clinical development with ALISTA, a topical formulation of alprostadil, which is thought to increase blood flow to the genital tissues in females. ALISTA phase 2 clinical data in postmenopausal women using the product at home demonstrated improved arousal.
VIVUS is a specialty pharmaceutical company focused on research, development and commercialization of products to restore sexual function. This article was prepared by Clinical Trials Week editors from staff and other reports. Copyright 2004, Clinical Trials Week via NewsRx.com & NewsRx.net.
©Copyright 2004, OBGYN & Reproduction Week via NewsRx.com & NewsRx.net
