drugset / Trial / NCT00746967

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

NCT00746967

Phase 2 Completed 267 enrolled Viatris Inc.
Non-randomizedSingle-groupOpen-labelTreatment

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 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.

Timeline

Start
2003-01
Primary completion
Completion
2004-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Sildenafil Unknown 25 mg Oral
Subject Sildenafil Unknown 50 mg Oral
Subject Sildenafil Unknown 100 mg Oral

Indications