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

NCT ID: NCT00746967

Last Updated: 2021-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

267 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2004-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Sexual Dysfunctions, Psychological Sexual Arousal Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type OTHER

sildenafil

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Huntsville, Alabama, United States

Site Status

Pfizer Investigational Site

Anchorage, Alaska, United States

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Anchorage, Alaska, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Jonesboro, Arkansas, United States

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Albany, California, United States

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Berkeley, California, United States

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Beverly Hills, California, United States

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Beverly Hills, California, United States

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Burbank, California, United States

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Fair Oaks, California, United States

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Hermosa Beach, California, United States

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Oakland, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Santa Monica, California, United States

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Torrance, California, United States

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Aurora, Colorado, United States

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Hamden, Connecticut, United States

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New London, Connecticut, United States

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Waterbury, Connecticut, United States

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Aventura, Florida, United States

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Brooksville, Florida, United States

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Jensen Beach, Florida, United States

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Miami, Florida, United States

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New Port Richey, Florida, United States

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Palm Harbor, Florida, United States

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Pembroke Pines, Florida, United States

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Plantation, Florida, United States

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St. Petersburg, Florida, United States

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Stuart, Florida, United States

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Stuart, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Marietta, Georgia, United States

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Savannah, Georgia, United States

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Boise, Idaho, United States

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Boise, Idaho, United States

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Evansville, Indiana, United States

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Fort Wayne, Indiana, United States

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Newburgh, Indiana, United States

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Leawood, Kansas, United States

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Crestview Hills, Kentucky, United States

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Florence, Kentucky, United States

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Metairie, Louisiana, United States

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Greenbelt, Maryland, United States

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Kalamazoo, Michigan, United States

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Southfield, Michigan, United States

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Creve Coeur, Missouri, United States

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Henderson, Nevada, United States

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North Las Vegas, Nevada, United States

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New Brunswick, New Jersey, United States

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New York, New York, United States

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Poughkeepsie, New York, United States

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Rochester, New York, United States

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White Plains, New York, United States

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Winston-Salem, North Carolina, United States

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Beachwood, Ohio, United States

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Cincinnati, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Reading, Pennsylvania, United States

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Reading, Pennsylvania, United States

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Temple, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Providence, Rhode Island, United States

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Anderson, South Carolina, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Sandy City, Utah, United States

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Charlottesville, Virginia, United States

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Richmond, Virginia, United States

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Renton, Washington, United States

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Seattle, Washington, United States

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Seattle, Washington, United States

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Milwaukee, Wisconsin, United States

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Cheyenne, Wyoming, United States

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Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481133&StudyName=An%20Open-Label%2C%20Extension%20Study%20Evaluating%20the%20Safety%2C%20Toleration%2C%20and%20Efficacy%20of%20Sildenafil%20in%20Women%20With%20Sexual%20Arousal%20Disorder.%0A

To obtain contact information for a study center near you, click here.

Other Identifiers

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A1481133

Identifier Type: -

Identifier Source: org_study_id

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