Back to resultsTopical Alprostadil for Female Sexual Arousal Disorder
Primary Purpose
Sexual Dysfunction, Physiological
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Topical alprostadil (PGE-1)
Sponsored by
About this trial
This is an interventional treatment trial for Sexual Dysfunction, Physiological focused on measuring Female sexual arousal disorder, Female sexual dysfunction
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
Sites / Locations
- Stanford University School of Medicine-Dept of OB/GYN
- Radiant Research
Outcomes
Primary Outcome Measures
FSEP
Secondary Outcome Measures
FSFI
Global assessment
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00324948
Brief Title
Topical Alprostadil for Female Sexual Arousal Disorder
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
VIVUS LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunction, Physiological
Keywords
Female sexual arousal disorder, Female sexual dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Topical alprostadil (PGE-1)
Primary Outcome Measure Information:
Title
FSEP
Secondary Outcome Measure Information:
Title
FSFI
Title
Global assessment
Title
Adverse events
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam Teichman, MD
Organizational Affiliation
Vivus Clinical Research Department
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University School of Medicine-Dept of OB/GYN
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Radiant Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
95249
Country
United States
12. IPD Sharing Statement
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Topical Alprostadil for Female Sexual Arousal Disorder
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