Status:
COMPLETED
An Open-Label, Extension Study Evaluating the Safety, Toleration, and Efficacy of Sildenafil in Women With Sexual Arousal Disorder
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Sexual Dysfunctions, Psychological
Sexual Arousal Disorder
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2004
Estimated Enrollment :
267 Patients enrolled
Trial Details
Trial ID
NCT00746967
Start Date
January 1 2003
End Date
February 1 2004
Last Update
February 1 2021
Active Locations (82)
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1
Pfizer Investigational Site
Huntsville, Alabama, United States, 35801
2
Pfizer Investigational Site
Anchorage, Alaska, United States, 99502
3
Pfizer Investigational Site
Anchorage, Alaska, United States, 99508
4
Pfizer Investigational Site
Tucson, Arizona, United States, 85712