Topical Alprostadil for Female Sexual Arousal Disorder

Sexual Dysfunction, Physiological Clinical Trial

Official title:

A Double-Blind, Randomized, 6-Month Evaluation of the Safety and Efficacy of Topical Alprostadil in Hysterectomized Women With Female Sexual Arousal Disorder (FSAD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00324948
• Other study ID #: Vivus-FSD-10
• Status: Completed
• Phase: Phase 2
• First received: May 9, 2006
• Last updated: March 9, 2009
• Start date: September 2004
• Est. completion date: November 2006

Study information

• Verified date: March 2009
• Source: VIVUS, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sexual Dysfunction, Physiological
• Sexual Dysfunctions, Psychological

Intervention

Drug:
• Topical alprostadil (PGE-1)

Locations

Country	Name	City	State
United States	Radiant Research	Cincinnati	Ohio
United States	Stanford University School of Medicine-Dept of OB/GYN	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
VIVUS, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FSEP
Secondary	FSFI
Secondary	Global assessment
Secondary	Adverse events