Topical Alprostadil for Female Sexual Arousal Disorder

This study has been completed.
Sponsor:
Information provided by:
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT00324948
First received: May 9, 2006
Last updated: March 9, 2009
Last verified: March 2009
  Purpose

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).


Condition Intervention Phase
Sexual Dysfunction, Physiological
Drug: Topical alprostadil (PGE-1)
Phase 2

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

Resource links provided by NLM:


Further study details as provided by VIVUS, Inc.:

Primary Outcome Measures:
  • FSEP

Secondary Outcome Measures:
  • FSFI
  • Global assessment
  • Adverse events

Estimated Enrollment: 300
Study Start Date: September 2004
Study Completion Date: November 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00324948

Locations
United States, California
Stanford University School of Medicine-Dept of OB/GYN
Stanford, California, United States, 94305
United States, Ohio
Radiant Research
Cincinnati, Ohio, United States, 95249
Sponsors and Collaborators
VIVUS, Inc.
Investigators
Study Director: Sam Teichman, MD Vivus Clinical Research Department
  More Information

No publications provided

Responsible Party: Wesley Day, VP Clinical, Vivus, Inc.
ClinicalTrials.gov Identifier: NCT00324948     History of Changes
Other Study ID Numbers: Vivus-FSD-10
Study First Received: May 9, 2006
Last Updated: March 9, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by VIVUS, Inc.:
Female sexual arousal disorder
Female sexual dysfunction

Additional relevant MeSH terms:
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Genital Diseases, Male
Genital Diseases, Female
Sexual and Gender Disorders
Mental Disorders
Alprostadil
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014