Trial Condition(s):
Erectile Dysfunction
BAY38-9456 (Vardenafil HCL tablet) in ED treatment for China registration.
Bayer Identifier:
10690
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
This study was to compare the efficacy of 3 doses of vardenafil, 5 mg, 10 mg and 20 mg, with matching placebo in Chinese male ED patients, treated for a maximum of 12 weeks.
Inclusion Criteria
- Men with ED for more than 6 months. ED defined according to the National Institute of Health, USA Department of Health and Human Services, consensus statement, as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance. - Stable heterosexual relationship
Exclusion Criteria
- Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the 6-month period prior to Visit 1 (Week -4) - Nitrate use - Other exclusion criteria apply
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Beijing, China, 100191 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 200001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site HangZhou, China, 310003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100044 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100853 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 200040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Randomized, Double-blind, Multi-centre, Parallel-goup Study to Investigate the Efficacy and Safety of Three Doses of BAY38-9456 (5 mg, 10 mg and 20 mg) Versus Placebo in the Treatment of Patients with Erectile Dysfunction
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
6
Primary Outcome
- Erectile Function domain score of the International Index of Erectile Function, questions 1-5 and 15Timeframe: 12 weeks
Secondary Outcome
- Global Assessment QuestionnaireTimeframe: 12 weeks
- Erectile Function domain score of the International Index of Erectile FunctionTimeframe: 12 weeks
- Safety and tolerabilityTimeframe: 12 weeks
Additional Information
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