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Alprostadil Phase 3 Study Initiated
MOUNTAIN VIEW, Calif., Sept. 7 /PRNewswire-FirstCall/ -- VIVUS Inc. , today announced that the Company has initiated sites to begin enrollment for its Phase 3 clinical study of ALISTA™ for the treatment of Female Sexual Arousal Disorder (FSAD). The study aims to enroll patients at approximately 40 sites in the U.S.
"Although FSAD was once thought to be a completely psychological condition, a large number of women experience significant changes in sexual response following a hysterectomy. We know now that FSAD is often a physical problem that may require medical treatment in order to restore a woman's ability to become aroused during an intimate relationship with her partner," said Marc Gittelman, MD, FACS, Executive Director of the South Florida Medical Research Center in Aventura, FL, and an investigator on the ALISTA Phase 3 study.
Female Sexual Arousal Disorder (FSAD) is one of the most common sexual problems experienced by women. Up to 75 percent of women with FSAD are postmenopausal or have undergone a hysterectomy. FSAD is characterized by diminished blood flow to the genital tissues resulting in a lack of genital engorgement and a reduction in pleasure and sensation during sexual stimulation.
Women who believe that they may be candidates for the ALISTA clinical study are encouraged to call the ALISTA Clinical Study Hotline at 650-934-5245 to receive additional information. To be considered for the study, candidates must be between the ages of 21 and 60, have undergone a hysterectomy, and are currently in a stable, monogamous relationship.
ALISTA is a proprietary formulation of alprostadil applied locally to the female genitalia. Alprostadil is a synthetic version of prostaglandin E1 (PGE1), a naturally occurring vasodilating agent. It is the same active ingredient found in VIVUS' product MUSE®, which is used to treat male erectile dysfunction. ALISTA is believed to increase blood flow to the female genitalia, thereby promoting engorgement and other natural processes that occur during sexual stimulation. With both issued and pending patents, the Company believes it has the dominant patent position for the local delivery of prostaglandins, such as alprostadil, for the treatment of women with FSD.
Source: Vivus, Inc.