drugset / Trial / 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

NCT00644631

Phase 4 Completed 300 enrolled Viatris Inc.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2003-06
Primary completion
Completion
2004-04

Drugs

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

Indications