Topical Alprostadil for Female Sexual Arousal Disorder

NCT ID: NCT00324948

Last Updated: 2009-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2006-11-30

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.

Conditions

Sexual Dysfunction, Physiological

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Topical alprostadil (PGE-1)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

VIVUS LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Vivus, Inc.

Principal Investigators

Sam Teichman, MD

Role: STUDY_DIRECTOR

Vivus Clinical Research Department

Locations

Stanford University School of Medicine-Dept of OB/GYN

Stanford, California, United States

Radiant Research

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

Vivus-FSD-10

Identifier Type: -

Identifier Source: org_study_id