Skip to main content
OpenTrials
Completed

NCT Number: NCT00324948

Topical Alprostadil for Female Sexual Arousal Disorder

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sexual Dysfunction, Physiological Genital Diseases Urogenital Diseases

Age range

21 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

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

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topical alprostadil (PGE-1)

Drug

Primary outcomes

  1. FSEP

Secondary outcomes

  1. FSFI

  2. Global assessment

  3. Adverse events

Sponsors and collaborators

Lead sponsor

VIVUS LLC

Industry

Registry information

Official study 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)

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
May 11, 2006
Registry last updated
Mar 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.