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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00324948
Other study ID # Vivus-FSD-10
Secondary ID
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
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