Trial Condition(s):

Erectile Dysfunction

Assessment of Vardenafil in patients with erectile dysfunction in Asia

Bayer Identifier:

10657

ClinicalTrials.gov Identifier:

NCT00668135

EudraCT Number:

Not Available

Study Completed

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
348
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Manila Doctors Hospital

Manila, Philippines

Status
Completed
 
Locations

National University Hospital

Singapore, Singapore, 119074

Status
Completed
 
Locations

Normah Medical Specialist Centre

Kuching, Malaysia

Status
Completed
 
Locations

Singapore General Hospital

Singapore, Singapore, 169608

Status
Completed
 
Locations

Siriraj Hospital, Mahidol

Bangkok, Thailand, 10700

Status
Completed
 
Locations

Changi General Hospital

Singapore, Singapore, 529889

Status
Completed
 
Locations

Kwong Wah Hospital

Hong Kong, Hong Kong, China

Status
Completed
 
Locations

Cipto Mangunkusumo Hospital

Jakarta, Indonesia, 10430

Status
Completed
 
Locations

Megah Medical Specialist Group

Petlaing Jaya, Malaysia, 47500

Status
Completed
 
Locations

Chulalongkorn University Hospital

Bangkok, Thailand

Status
Completed
 
Locations

Cardinal Santos Medical Centre

Manila, Philippines, 150

Status
Completed
 
Locations

Ramathibodhi Hospital

Bangkok, Thailand

Status
Completed
 
Locations

University of Malaya

Kuala Lumpur, Malaysia

Status
Completed
 
Locations

Damai Service Hospital

Kuala Lumpur, Malaysia, 51200

Status
Completed
 

Trial Design