NCT00644631

A Multicenter, Randomized, Parallel Group, Double-Blind, Placebo Controlled, Flexible Dose Escalation Study To Evaluate Sexual And Relationship Satisfaction In The Female Partner Of Men With Erectile Dysfunction Treated With Sildenafil Citrate

A Multicenter, Randomized, Parallel Group, Double-Blind, Placebo Controlled, Flexible Dose Escalation Study To Evaluate Sexual And Relationship Satisfaction In The Female Partner Of Men With Erectile Dysfunction Treated With Viagra (Sildenafil Citrate) In The United States

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

To compare the effects of sildenafil versus placebo on the female partner's sexual satisfaction as assessed by Question 3 of Female Partner of Erectile Dysfunction (ED) Subject Questionnaire (FePEDS-Q): "Over the past 4 weeks, when you had sexual intercourse, how often was it satisfactory for you?" For ED subjects, determine difference in the Erectile Function domain of International Index of Erectile Function (IIEF) between sildenafil citrate and placebo at end of the treatment phase and determine the overall relationship between improved erectile function and increased ED subject and female partner satisfaction.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	sildenafil	sildenafil 50 mg (initial dose) tablet by mouth 30 to 60 minutes prior to sexual activity for 12 weeks; depending upon safety, efficacy and tolerability, the dose could be increased to 100 mg or reduced to 25 mg, if necessary.
DRUG	placebo	placebo tablet by mouth 30 to 60 minutes prior to sexual activity for 12 weeks

Timeline

• Start date: 2003-06-01
• Completion: 2004-04-01
• First posted: 2008-03-27
• Last updated: 2021-02-01

Locations

31 sites across 1 country: United States