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

Last updated on March 15, 2019

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Study Location
Pfizer Investigational Site
Huntsville, Alabama, 35801 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psychological Sexual Dysfunctions, Sexual Arousal Disorder
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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).

NCT00746967
Pfizer
Completed
An Open-Label, Extension Study Evaluating the Safety, Toleration, and Efficacy of Sildenafil in Women With Sexual Arousal Disorder

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