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

NCT00746967 | Completed Phase 2

• 1 other identifier: A1481133
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 82

Brief 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.

Conditions

Sexual Dysfunctions, Psychological; Sexual Arousal Disorder

Outcome Measures

Primary Outcomes (1)

• Safety/toleration of oral sildenafil.

  Continuous

Secondary Outcomes (13)

• The score for each of the individual questions 3,5 and 9 on the SQoL-F

  Week 14 and Week 26

• The total satisfaction score on the Inventory of Treatment Satisfaction (ITS-modified EDITS)

  Week 14 and Week 26

• The score for each of the individual questions 3,5,6 and 7 on the ITS-modified EDITS

  Week 14 and Week 26

• 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

• 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

Study Arms (1)

Arm 1

OTHER

Drug: sildenafil

Interventions

sildenafil 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

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (82)

Pfizer Investigational Site

Huntsville, Alabama, 35801, United States

Location

Pfizer Investigational Site

Anchorage, Alaska, 99502, United States

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Anchorage, Alaska, 99508, United States

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Tucson, Arizona, 85712, United States

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Tucson, Arizona, 85719, United States

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Jonesboro, Arkansas, 72401, United States

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Albany, California, 94706, United States

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Berkeley, California, 94705, United States

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Beverly Hills, California, 90210, United States

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Beverly Hills, California, 90212, United States

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Burbank, California, 91506, United States

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Fair Oaks, California, 95628, United States

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Hermosa Beach, California, 90254, United States

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Oakland, California, 94612, United States

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San Diego, California, 92103, United States

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San Diego, California, 92108, United States

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Santa Monica, California, 90404, United States

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Torrance, California, 90505, United States

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Aurora, Colorado, 80012, United States

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Hamden, Connecticut, 06518, United States

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New London, Connecticut, 06320, United States

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Waterbury, Connecticut, 06708, United States

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Aventura, Florida, 33180, United States

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Brooksville, Florida, 34614, United States

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Jensen Beach, Florida, 34957, United States

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Miami, Florida, 33186, United States

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New Port Richey, Florida, 34652, United States

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Palm Harbor, Florida, 34683, United States

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Pembroke Pines, Florida, 33028, United States

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Plantation, Florida, 33324, United States

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St. Petersburg, Florida, 33710, United States

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Stuart, Florida, 34994, United States

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Stuart, Florida, 34996, United States

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West Palm Beach, Florida, 33409, United States

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Atlanta, Georgia, 30309, United States

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Atlanta, Georgia, 30342, United States

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Marietta, Georgia, 30060, United States

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Savannah, Georgia, 31405, United States

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Boise, Idaho, 83702, United States

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Boise, Idaho, 83712, United States

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Evansville, Indiana, 47714, United States

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Fort Wayne, Indiana, 46825, United States

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Newburgh, Indiana, 47630, United States

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Leawood, Kansas, 66211, United States

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Crestview Hills, Kentucky, 41017, United States

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Florence, Kentucky, 41042, United States

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Metairie, Louisiana, 70002, United States

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Greenbelt, Maryland, 20770, United States

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Kalamazoo, Michigan, 49009, United States

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Southfield, Michigan, 48034, United States

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Creve Coeur, Missouri, 63141, United States

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Henderson, Nevada, 89014, United States

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North Las Vegas, Nevada, 89030, United States

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New Brunswick, New Jersey, 08903, United States

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New York, New York, 10021, United States

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Poughkeepsie, New York, 12601, United States

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Rochester, New York, 14609, United States

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White Plains, New York, 10603, United States

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Winston-Salem, North Carolina, 27103, United States

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Beachwood, Ohio, 44122-5402, United States

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Cincinnati, Ohio, 45267-0559, United States

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Philadelphia, Pennsylvania, 19106, United States

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Philadelphia, Pennsylvania, 19148, United States

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Reading, Pennsylvania, 19606, United States

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Reading, Pennsylvania, 19607-1649, United States

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Temple, Pennsylvania, 19560, United States

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West Reading, Pennsylvania, 19611-1499, United States

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Providence, Rhode Island, 02904, United States

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Anderson, South Carolina, 29621, United States

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Memphis, Tennessee, 38119, United States

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Austin, Texas, 78705, United States

Location

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Austin, Texas, 78758, United States

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Dallas, Texas, 75231, United States

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Houston, Texas, 77024, United States

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Sandy City, Utah, 84070, United States

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Charlottesville, Virginia, 22903, United States

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Richmond, Virginia, 23294, United States

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Renton, Washington, 98055, United States

Location

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Seattle, Washington, 98105, United States

Location

Pfizer Investigational Site

Seattle, Washington, 98115, United States

Location

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Milwaukee, Wisconsin, 53209, United States

Location

Pfizer Investigational Site

Cheyenne, Wyoming, 82001, United States

Location

Related Links

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

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: September 4, 2008
• Study Start: January 1, 2003
• Study Completion: February 1, 2004
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

US (82)