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

Completed · Phase 2

Conditions studied: Sexual Dysfunctions, Psychological, Sexual Arousal Disorder

In brief

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.

Key facts

Study ID

NCT00746967

Run by

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

People needed

267

Starts

2003-01-01

Expected to finish

2004-02-01

Last updated by the study team

2021-02-01

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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).

Where it is running

• Pfizer Investigational Site — Anchorage, Alaska, United States
• Pfizer Investigational Site — Anchorage, Alaska, United States
• Pfizer Investigational Site — Tucson, Arizona, United States
• Pfizer Investigational Site — Tucson, Arizona, United States
• Pfizer Investigational Site — Jonesboro, Arkansas, United States
• Pfizer Investigational Site — Albany, California, 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 — Burbank, California, United States
• Pfizer Investigational Site — Fair Oaks, California, United States
• Pfizer Investigational Site — Hermosa Beach, California, United States
• Pfizer Investigational Site — Oakland, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Santa Monica, California, United States
• Pfizer Investigational Site — Torrance, California, United States
• Pfizer Investigational Site — Aurora, Colorado, United States
• Pfizer Investigational Site — Hamden, Connecticut, United States
• Pfizer Investigational Site — New London, Connecticut, United States
• Pfizer Investigational Site — Waterbury, Connecticut, United States
• Pfizer Investigational Site — Aventura, Florida, United States
• Pfizer Investigational Site — Brooksville, Florida, United States
• Pfizer Investigational Site — Jensen Beach, Florida, United States
• Pfizer Investigational Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.