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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.267 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

267

Conditions

Sexual Dysfunctions, Psychological Sexual Arousal Disorder

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (82)

Pfizer Investigational Site

Huntsville, Alabama, United States

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

Outcomes

Primary Outcomes

Safety/toleration of oral sildenafil.

Time frame: Continuous