Trial Condition(s):
Erectile Dysfunction
Assessment of Vardenafil in patients with erectile dysfunction in Asia
Bayer Identifier:
10657
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
To demonstrate the efficacy, safety and tolerability of 10 mg oral vardenafil (BAY 38-9456) compared to placebo for a period of 12 weeks in men with erectile dysfunction (ED)
Inclusion Criteria
- Age: 20 years and older- Males with erectile dysfunction - Stable heterosexual relationship
Exclusion Criteria
- Primary hypoactive sexual desire - History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months- Nitrate use - Other exclusion criteria apply according to the Summary of Product Characteristics
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Manila Doctors Hospital Manila, Philippines | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National University Hospital Singapore, Singapore, 119074 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Normah Medical Specialist Centre Kuching, Malaysia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Singapore General Hospital Singapore, Singapore, 169608 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Siriraj Hospital, Mahidol Bangkok, Thailand, 10700 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Changi General Hospital Singapore, Singapore, 529889 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kwong Wah Hospital Hong Kong, Hong Kong, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cipto Mangunkusumo Hospital Jakarta, Indonesia, 10430 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Megah Medical Specialist Group Petlaing Jaya, Malaysia, 47500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chulalongkorn University Hospital Bangkok, Thailand | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cardinal Santos Medical Centre Manila, Philippines, 150 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ramathibodhi Hospital Bangkok, Thailand | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Malaya Kuala Lumpur, Malaysia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Damai Service Hospital Kuala Lumpur, Malaysia, 51200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Randomised, double blind, placebo controlled, parallel group, multi-centre, multinational study to evaluate the efficacy and tolerability of Vardenafil (BAY 38-9456) in treatment of male erectile dysfunction in Asia
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- International Index of Erectile Function (IIEF) Questionnaire and Sexual Encounter Profile question 2 (SEP 2) and Sexual Encounter Profile question 3 (SEP 3)Timeframe: 12 weeks
Secondary Outcome
- Global Assessment QuestionTimeframe: 12 weeks
- Other diary responsesTimeframe: 12 weeks
- Safety and tolerabilityTimeframe: 12 weeks
Additional Information
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