Topical Alprostadil for Female Sexual Arousal Disorder

Phase 2

Completed

• Conditions: Sexual Dysfunction, Physiological

• Registration Number: NCT00324948
• Lead Sponsor: VIVUS LLC

Brief Summary

Approximately 300 patients with female sexual arousal disorder who meet eligibility criteria will be enrolled and randomized to receive either active drug or matching placebo. After a two-month, non-treatment period, patients will receive study drug for 6 months and will record information about sexual encounters in a daily diary. Study drug will be applied directly to the genital area 30-60 minutes before initiation of sexual activity. The endpoint of the study is based on the use of a standard measure of sexual function (FSEP).

Detailed Description

This is a multicenter, double-blind, randomized, placebo-controlled, parallel-design study involving about 300 women who are 21-60 years of age inclusive, who have undergone a hysterectomy (with or without oophorectomy), and who have a primary diagnosis of FSAD. The diagnosis of FSAD will be made based on a medical and sexual history and confirmed using a structured interview by trained personnel. Study subjects will undergo a 2-month non-treatment run-in period followed by a 6-month period of blinded study therapy. Study drug is applied topically to the genitalia 30-60 minutes prior to initiation of sexual activity. Study subjects will complete several questionnaires at various times during the study and will complete a daily diary. The study endpoint is based on the FSEP and other standard questionnaires, as well as safety and tolerability of study drug.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2006-05-09
• Study First Submitted QC: 2006-05-09
• Study First Posted: 2006-05-11
• Primary Completion: 2006-08
• Study Completion: 2006-11
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-09
• Last Update Posted: 2009-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Women aged 21-60 who have undergone a hysterectomy
• Have a primary diagnosis of female sexual arousal disorder
• Be willing to comply with all study requirements and visit schedules

Exclusion Criteria

• Known allergy to alprostadil or product excipients
• Have a genital inflammatory or infectious condition or STD
• Have a significant medical condition that would interfere with the study
• Have received an investigational drug within the prior 30 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
FSEP

Secondary Outcome Measures

Name	Time	Method
Global assessment
Adverse events
FSFI

Trial Locations

Locations (2)

Stanford University School of Medicine-Dept of OB/GYN; 🇺🇸 Stanford, California, United States

Radiant Research; 🇺🇸 Cincinnati, Ohio, United States