Levitra (Vardenafil, BAY38-9456) Partner Satisfaction Study II
Completed
Bayer
Phase 4
2006-07-01
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.
A Study Evaluating Vardenafil Compared to Placebo in Subjects With Erectile Dysfunction (ED) and Dyslipidemia
Completed
GlaxoSmithKline
Phase 4
2006-05-22
This is a study consisting of four periods (screening, run-in, treatment, follow-up). A
four-week treatment-free, run-in period where the subject will make at least four attempts at
intercourse on four separate days with at least 50% of the attempts must be unsuccessful.
During run-in the subjects will be using a stopwatch to measure the time from erection
perceived hard enough for penetration until withdrawal from the partner's vagina. Next there
are 12 weeks of treatment with either placebo or LEVITRA. Each subject will be required to
visit the clinic on 5 occasions over a period of 4 months.
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