Evaluation of the Safety and Efficacy of Vardenafil in Subjects With Erectile Dysfunction
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction
Intervention: Levitra (Vardenafil, BAY38-9456) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
Summary
Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection
sufficient for satisfactory sexual performance. An ideal treatment option should be
effective and reliable, have minimal side effects, be simple to use and affordable. The aim
of this study was to investigate safety, tolerability and efficacy of vardenafil following a
flexible dose treatment schedule in subjects with varying aetiology.
Clinical Details
Official title: Open-label, Multi-centre, Study to Investigate the Safety, Tolerability and Efficacy of Flexible Doses of Vardenafil Given on Demand in Males With Erectile Dysfunction
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: International Index of Erectile Function - Erectile Function Domain
Secondary outcome: Sexual Encounter Profile Question 2 and 3Global Assessment Question Other diary based variables Safety and tolerability
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Men >/= 18 years of age,
- ED 6 months or longer
- Stable sexual relationship for > 6 month.
Exclusion Criteria:
- Primary hypoactive sexual desire
- History of myocardial infarction, stroke or life-threatening arrhythmia within prior
6 month
- Nitrate therapy
- Other exclusion criteria apply according to the Summary of Product Characteristics
Locations and Contacts
Additional Information
Click here and search for drug information provided by the FDA. Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. Click here to find results for studies related to Bayer Healthcare products.
Starting date: March 2003
Last updated: December 10, 2014
|