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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
352
Unnamed facility
Bruxelles - Brussel, Belgium
Unnamed facility
Genk, Belgium
Unnamed facility
Leuven, Belgium
Unnamed facility
Liège, Belgium
Unnamed facility
Roeselare, Belgium
Unnamed facility
La Rochelle, France
Maintenance of erection in men with ED, Improvement of their female partners sexual quality of life
Time frame: 12 weeks
SEP3 at weeks 4, 12, 18, and 24 of treatment compared to placebo
Time frame: 24 weeks
Additional Subject Diary questions at weeks 4, 12, 18, and 24, LOCF, and over entire treatment period compared to placebo
Time frame: 24 weeks
Global confidence question (GCQ) at weeks 12, and 24 of treatment compared to placebo. IIEF, TSS, mSLQQ-QOL, Partnership questionnaire (PFB20)
Time frame: 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Lille, France
Unnamed facility
Lyon, France
Unnamed facility
Marseille, France
Unnamed facility
Marseille, France
...and 37 more locations