NCT00377793

Levitra (Vardenafil, BAY38-9456) Partner Satisfaction Study II

A Randomized, Double Blind, Parallel Group Study of Vardenafil Flexible Dose Versus Placebo in Males With Erectile Dysfunction and Their Female Partners Sexual Quality of Life. PARTNER II

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 352 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This trial is to provide additional important information on the impact of the treatment of the man its ED with vardenafil on partnership. This study is being run at up to 50 study centers in Europe and South Africa to evaluate the use of vardenafil in adult men with erectile dysfunction (often called impotence), and their female partner's sexual quality of life. Many men experience occasional erectile problems during their lives. However, when this becomes a continued problem, it can affect both the man and his female partner. The causes of erectile dysfunction are varied and may be due to physiological or emotional reasons. This study is designed to 1) study the effectiveness and safety of vardenafil, and 2) show whether treating a man its erectile dysfunction with vardenafil will improve his female partner its sexual quality of life. The second part (week 12) of the study (Educational program) a subgroup of subjects/couples, approximately 50% of the randomized subjects, will receive an educational program concerning ED in the from of a DVD.

Conditions

• Sexual Dysfunction
• Male Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	Levitra (Vardenafil, BAY38-9456)
DRUG	Placebo

Timeline

• Start date: 2006-07-01
• Completion: 2007-08-01
• First posted: 2006-09-18
• Last updated: 2014-12-24

Locations

47 sites across 7 countries: Belgium, France, Germany, Italy, Netherlands, South Africa, Spain