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NCT00746967 Clinical Trial

An Open-Label, Extension Study Evaluating the Safety, Toleration, and Efficacy of Sildenafil in Women With Sexual Arousal Disorder

Sexual Dysfunctions, Psychological Clinical Trial

Official title:
An Open-Label, Multi-Center Extension Study To Evaluate The Safety, Toleration And Sustained Efficacy Of Oral Sildenafil Administered To Women Who Have Been Diagnosed With Female Sexual Arousal Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00746967
Other study ID # A1481133
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 2003
Est. completion date February 2004

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and toleration of oral sildenafil administered as required by women with Female Sexual Arousal Disorder (FSAD) who successfully complete one of the following Pfizer-sponsored, 12-week, double-blinded clinical trials: A1481082 or A1481123. Addition of this 52-week open-label extension will increase the total duration of sildenafil exposure to 64 weeks. Sustained efficacy will also be evaluated after 3 and 6 months of open-label therapy.

Recruitment information / eligibility
Status Completed
Enrollment 267
Est. completion date February 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Included were subjects who completed Pfizer study A1481082 or A1481123 without a major protocol violation and with all treatment-related adverse events resolved prior to crossover into the open-label study. - For subjects receiving hormone replacement therapy and/or selective serotonin reuptake inhibitor treatment, dosage of these must be stable at the start of this extension study and remain stable throughout. - Subjects should continue to maintain a stable sexual relationship throughout the study. Exclusion Criteria: - Excluded were subjects who experienced either treatment-related serious adverse events or significant treatment-related laboratory abnormalities in the previous study, and subjects who misused study medication and/or failed to adequately account for study medication in the previous study, or who were non-compliant with visits. - Also excluded were subjects who were currently prescribed and/or taking nitrates or nitric oxide donors in any form (oral, sublingual, buccal, transdermal, inhalational or aerosols).

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• sildenafil
sildenafil 50 mg (starting dose) tablet by mouth taken as needed 1 hour before anticipated sexual activity; the dose could be increased to 100 mg or decreased to 25 mg; the duration of therapy in this open-label study was 52 weeks

Locations
Country Name City State
United States Pfizer Investigational Site Albany California
United States Pfizer Investigational Site Anchorage Alaska
United States Pfizer Investigational Site Anchorage Alaska
United States Pfizer Investigational Site Anderson South Carolina
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Aurora Colorado
United States Pfizer Investigational Site Austin Texas
United States Pfizer Investigational Site Austin Texas
United States Pfizer Investigational Site Aventura Florida
United States Pfizer Investigational Site Beachwood Ohio
United States Pfizer Investigational Site Berkeley California
United States Pfizer Investigational Site Beverly Hills California
United States Pfizer Investigational Site Beverly Hills California
United States Pfizer Investigational Site Boise Idaho
United States Pfizer Investigational Site Boise Idaho
United States Pfizer Investigational Site Brooksville Florida
United States Pfizer Investigational Site Burbank California
United States Pfizer Investigational Site Charlottesville Virginia
United States Pfizer Investigational Site Cheyenne Wyoming
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Crestview Hills Kentucky
United States Pfizer Investigational Site Creve Coeur Missouri
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Evansville Indiana
United States Pfizer Investigational Site Fair Oaks California
United States Pfizer Investigational Site Florence Kentucky
United States Pfizer Investigational Site Fort Wayne Indiana
United States Pfizer Investigational Site Greenbelt Maryland
United States Pfizer Investigational Site Hamden Connecticut
United States Pfizer Investigational Site Henderson Nevada
United States Pfizer Investigational Site Hermosa Beach California
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Huntsville Alabama
United States Pfizer Investigational Site Jensen Beach Florida
United States Pfizer Investigational Site Jonesboro Arkansas
United States Pfizer Investigational Site Kalamazoo Michigan
United States Pfizer Investigational Site Leawood Kansas
United States Pfizer Investigational Site Marietta Georgia
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site Metairie Louisiana
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Milwaukee Wisconsin
United States Pfizer Investigational Site New Brunswick New Jersey
United States Pfizer Investigational Site New London Connecticut
United States Pfizer Investigational Site New Port Richey Florida
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Newburgh Indiana
United States Pfizer Investigational Site North Las Vegas Nevada
United States Pfizer Investigational Site Oakland California
United States Pfizer Investigational Site Palm Harbor Florida
United States Pfizer Investigational Site Pembroke Pines Florida
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Plantation Florida
United States Pfizer Investigational Site Poughkeepsie New York
United States Pfizer Investigational Site Providence Rhode Island
United States Pfizer Investigational Site Reading Pennsylvania
United States Pfizer Investigational Site Reading Pennsylvania
United States Pfizer Investigational Site Renton Washington
United States Pfizer Investigational Site Richmond Virginia
United States Pfizer Investigational Site Rochester New York
United States Pfizer Investigational Site Saint Petersburg Florida
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Sandy Utah
United States Pfizer Investigational Site Santa Monica California
United States Pfizer Investigational Site Savannah Georgia
United States Pfizer Investigational Site Seattle Washington
United States Pfizer Investigational Site Seattle Washington
United States Pfizer Investigational Site Southfield Michigan
United States Pfizer Investigational Site Stuart Florida
United States Pfizer Investigational Site Stuart Florida
United States Pfizer Investigational Site Temple Pennsylvania
United States Pfizer Investigational Site Torrance California
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site Waterbury Connecticut
United States Pfizer Investigational Site West Palm Beach Florida
United States Pfizer Investigational Site West Reading Pennsylvania
United States Pfizer Investigational Site White Plains New York
United States Pfizer Investigational Site Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety/toleration of oral sildenafil. Continuous
Secondary The score for each of the individual questions 3,5 and 9 on the SQoL-F Week 14 and Week 26
Secondary The total satisfaction score on the Inventory of Treatment Satisfaction (ITS-modified EDITS) Week 14 and Week 26
Secondary The score for each of the individual questions 3,5,6 and 7 on the ITS-modified EDITS Week 14 and Week 26
Secondary The Arousal-lubrication Domain from the SFQ. The score for this domain is the sum of scores from Questions 11 and 12 from the SFQ Week 14 and Week 26
Secondary The Arousal-sensation Domain from the SFQ. The score for this domain is sum of scores from Questions 7,8,9 and 10 from the SFQ. Week 14 and Week 26
Secondary The total Quality of Life score on the Sexual Quality of Life (SQoL-F) Week 14 and Week 26
Secondary The Desire domain from the SFQ. Specifically, the sum of scores from questions 1,2,3,4,15 and 28 (frequency of pleasurable thoughts, wanted to be touched, wanted sex, initiated sex, had sex with penetration, looked forward to sex, respectively). Week 14 and Week 26
Secondary Question 16 from the SFQ at Weeks 14 and 26 (enjoyment of penetration and intercourse). Week 14 and Week 26
Secondary The Orgasm domain from the SFQ. The score for this domain is the sum of scores from questions 24,25 and 26 (orgasm frequency, level of pleasure and ease in achieving, respectively). Week 14 and Week 26
Secondary The individual questions of the Orgasm domain. Week 14 and Week 26
Secondary SFQ Question 27 (confidence as sexual partner). Week 14 and Week 26
Secondary SFQ Question 29 (disappointment with response). Week 14 and Week 26
Secondary Global Efficacy Question (SFQ Question 34, satisfaction with whole of sexual life) Week 14 and Week 26
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Completed NCT00360555 - A Twenty Four Uptitration Trial of Flibanserin Versus Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder Phase 3
Completed NCT00360529 - 24-Week Placebo-Controlled Trial of Flibanserin Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder Phase 3
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