Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Bayer |
---|---|
Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00377793 |
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.
Condition | Intervention | Phase |
---|---|---|
Sexual Dysfunction Male Erectile Dysfunction |
Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Enrollment: | 353 |
Study Start Date: | July 2006 |
Study Completion Date: | August 2007 |
Arms | Assigned Interventions |
---|---|
Arm 1: Experimental | Drug: Levitra (Vardenafil, BAY38-9456) |
Arm 2: Placebo Comparator | Drug: Placebo |
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion Criteria: Partner
Exclusion Criteria:
Exclusion criteria: Partner
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer Schering Pharma AG ( Medical Affairs Therapeutic Area Head ) |
Study ID Numbers: | 12146, EudraCT 2006-001228-37 |
Study First Received: | September 8, 2006 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00377793 |
Health Authority: | Spain: Spanish Agency of Medicines; Germany: Federal Institute for Drugs and Medical Devices |
Sexual Dysfunctions, Psychological Vardenafil Sexual Dysfunction, Physiological Mental Disorders |
Quality of Life Genital Diseases, Male Erectile Dysfunction |
Phosphodiesterase Inhibitors Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Sexual and Gender Disorders Pharmacologic Actions |