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

January 28, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

267

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Pfizer Investigational Site
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Pfizer Investigational Site
      • Anchorage, Alaska, United States, 99502
        • Pfizer Investigational Site
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Pfizer Investigational Site
      • Tucson, Arizona, United States, 85719
        • Pfizer Investigational Site
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Pfizer Investigational Site
    • California
      • Albany, California, United States, 94706
        • Pfizer Investigational Site
      • Berkeley, California, United States, 94705
        • Pfizer Investigational Site
      • Beverly Hills, California, United States, 90212
        • Pfizer Investigational Site
      • Beverly Hills, California, United States, 90210
        • Pfizer Investigational Site
      • Burbank, California, United States, 91506
        • Pfizer Investigational Site
      • Fair Oaks, California, United States, 95628
        • Pfizer Investigational Site
      • Hermosa Beach, California, United States, 90254
        • Pfizer Investigational Site
      • Oakland, California, United States, 94612
        • Pfizer Investigational Site
      • San Diego, California, United States, 92108
        • Pfizer Investigational Site
      • San Diego, California, United States, 92103
        • Pfizer Investigational Site
      • Santa Monica, California, United States, 90404
        • Pfizer Investigational Site
      • Torrance, California, United States, 90505
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Pfizer Investigational Site
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Pfizer Investigational Site
      • New London, Connecticut, United States, 06320
        • Pfizer Investigational Site
      • Waterbury, Connecticut, United States, 06708
        • Pfizer Investigational Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Pfizer Investigational Site
      • Brooksville, Florida, United States, 34614
        • Pfizer Investigational Site
      • Jensen Beach, Florida, United States, 34957
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33186
        • Pfizer Investigational Site
      • New Port Richey, Florida, United States, 34652
        • Pfizer Investigational Site
      • Palm Harbor, Florida, United States, 34683
        • Pfizer Investigational Site
      • Pembroke Pines, Florida, United States, 33028
        • Pfizer Investigational Site
      • Plantation, Florida, United States, 33324
        • Pfizer Investigational Site
      • Saint Petersburg, Florida, United States, 33710
        • Pfizer Investigational Site
      • Stuart, Florida, United States, 34996
        • Pfizer Investigational Site
      • Stuart, Florida, United States, 34994
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States, 33409
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30309
        • Pfizer Investigational Site
      • Marietta, Georgia, United States, 30060
        • Pfizer Investigational Site
      • Savannah, Georgia, United States, 31405
        • Pfizer Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83702
        • Pfizer Investigational Site
      • Boise, Idaho, United States, 83712
        • Pfizer Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Pfizer Investigational Site
      • Fort Wayne, Indiana, United States, 46825
        • Pfizer Investigational Site
      • Newburgh, Indiana, United States, 47630
        • Pfizer Investigational Site
    • Kansas
      • Leawood, Kansas, United States, 66211
        • Pfizer Investigational Site
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Pfizer Investigational Site
      • Florence, Kentucky, United States, 41042
        • Pfizer Investigational Site
    • Louisiana
      • Metairie, Louisiana, United States, 70002
        • Pfizer Investigational Site
    • Maryland
      • Greenbelt, Maryland, United States, 20770
        • Pfizer Investigational Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Pfizer Investigational Site
      • Southfield, Michigan, United States, 48034
        • Pfizer Investigational Site
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Pfizer Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Pfizer Investigational Site
      • North Las Vegas, Nevada, United States, 89030
        • Pfizer Investigational Site
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10021
        • Pfizer Investigational Site
      • Poughkeepsie, New York, United States, 12601
        • Pfizer Investigational Site
      • Rochester, New York, United States, 14609
        • Pfizer Investigational Site
      • White Plains, New York, United States, 10603
        • Pfizer Investigational Site
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
    • Ohio
      • Beachwood, Ohio, United States, 44122-5402
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45267-0559
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19148
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19106
        • Pfizer Investigational Site
      • Reading, Pennsylvania, United States, 19606
        • Pfizer Investigational Site
      • Reading, Pennsylvania, United States, 19607-1649
        • Pfizer Investigational Site
      • Temple, Pennsylvania, United States, 19560
        • Pfizer Investigational Site
      • West Reading, Pennsylvania, United States, 19611-1499
        • Pfizer Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Pfizer Investigational Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Pfizer Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, United States, 78705
        • Pfizer Investigational Site
      • Austin, Texas, United States, 78758
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75231
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77024
        • Pfizer Investigational Site
    • Utah
      • Sandy, Utah, United States, 84070
        • Pfizer Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23294
        • Pfizer Investigational Site
    • Washington
      • Renton, Washington, United States, 98055
        • Pfizer Investigational Site
      • Seattle, Washington, United States, 98105
        • Pfizer Investigational Site
      • Seattle, Washington, United States, 98115
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Pfizer Investigational Site
    • Wyoming
      • Cheyenne, Wyoming, United States, 82001
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 1
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety/toleration of oral sildenafil.
Time Frame: Continuous
Continuous

Secondary Outcome Measures

Outcome Measure
Time Frame
The score for each of the individual questions 3,5 and 9 on the SQoL-F
Time Frame: Week 14 and Week 26
Week 14 and Week 26
The total satisfaction score on the Inventory of Treatment Satisfaction (ITS-modified EDITS)
Time Frame: Week 14 and Week 26
Week 14 and Week 26
The score for each of the individual questions 3,5,6 and 7 on the ITS-modified EDITS
Time Frame: Week 14 and Week 26
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
Time Frame: Week 14 and Week 26
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.
Time Frame: Week 14 and Week 26
Week 14 and Week 26
The total Quality of Life score on the Sexual Quality of Life (SQoL-F)
Time Frame: Week 14 and Week 26
Week 14 and Week 26
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).
Time Frame: Week 14 and Week 26
Week 14 and Week 26
Question 16 from the SFQ at Weeks 14 and 26 (enjoyment of penetration and intercourse).
Time Frame: Week 14 and Week 26
Week 14 and Week 26
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).
Time Frame: Week 14 and Week 26
Week 14 and Week 26
The individual questions of the Orgasm domain.
Time Frame: Week 14 and Week 26
Week 14 and Week 26
SFQ Question 27 (confidence as sexual partner).
Time Frame: Week 14 and Week 26
Week 14 and Week 26
SFQ Question 29 (disappointment with response).
Time Frame: Week 14 and Week 26
Week 14 and Week 26
Global Efficacy Question (SFQ Question 34, satisfaction with whole of sexual life)
Time Frame: Week 14 and Week 26
Week 14 and Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

March 31, 2008

First Submitted That Met QC Criteria

September 3, 2008

First Posted (Estimate)

September 4, 2008

Study Record Updates

Last Update Posted (Actual)

February 1, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1481133

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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