NCT00746967

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

An Open-Label, Multi-Center Extension Study To Evaluate The Safety, Toleration And Sustained Efficacy Of Oral Sildenafil Administered To Women Who Have Been Diagnosed With Female Sexual Arousal Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 267 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sexual Dysfunctions, Psychological
• Sexual Arousal Disorder

Interventions

Type	Name	Description
DRUG	sildenafil	sildenafil 50 mg (starting dose) tablet by mouth taken as needed 1 hour before anticipated sexual activity; the dose could be increased to 100 mg or decreased to 25 mg; the duration of therapy in this open-label study was 52 weeks

Timeline

• Start date: 2003-01-01
• Completion: 2004-02-01
• First posted: 2008-09-04
• Last updated: 2021-02-01

Locations

82 sites across 1 country: United States