NCT00648596

A Study to Evaluate Self-esteem and Relationships in Males With Erectile Dysfuntion

An International, Multicentre, Randomized, Parallel Group, Double Blind, Placebo Controlled, Flexible Dose Study to Evaluate Self-esteem and Relationships in Males With Erectile Dysfunction Treated With Sildenafil Citrate

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 780 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the improvement in the self-esteem domain score of the Self-Esteem/Overall Relationship (SEAR) questionnaire and the improvement in erectile function (obtained from the Erectile Function \[EF\] domain of the International Index of Erectile Function \[IIEF\]). Furthermore, to determine if the improvement obtained in self-esteem was related to the main erectile dysfunction (ED) co-morbidities type and/or number.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	sildenafil	sildenafil 50 mg tablet by mouth 1 hour before sexual activity for 12 weeks; the dose could be increased to 100 mg or decreased to 25 mg.
DRUG	placebo	placebo tablet by mouth 1 hour before sexual activity for 12 weeks

Timeline

• Start date: 2003-05-01
• Completion: 2004-05-01
• First posted: 2008-04-01
• Last updated: 2021-02-01

Locations

66 sites across 8 countries: Finland, France, Italy, Poland, Russia, Spain, Sweden, United Kingdom