Assessment of Vardenafil in Patients With Erectile Dysfunction in Asia

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00668135
• Collaborator: (none)
• Enrollment: 348
• Locations: 13
• Arms: 2
• Duration (Months): 13
• Patients Per Site: 26.8
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

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)

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: Vardenafil (Levitra, BAY38-9456); Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 348 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Mar 1, 2003
• Actual Primary Completion Date: Apr 1, 2004
• Actual Study Completion Date: Apr 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Vardenafil (Levitra, BAY38-9456); Vardenafil 10 mg orally on demand prior to intercourse
Placebo Comparator: Arm 2	Drug: Placebo; Matching placebo

Outcome Measures

Primary Outcome Measures

1. International Index of Erectile Function (IIEF) Questionnaire and Sexual Encounter Profile question 2 (SEP 2) and Sexual Encounter Profile question 3 (SEP 3) [12 weeks]

Secondary Outcome Measures

1. Global Assessment Question [12 weeks]

2. Other diary responses [12 weeks]

3. Safety and tolerability [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Hong Kong		Hong Kong
2		Jakarta		Indonesia	10430
3		Petlaing Jaya	Salangor	Malaysia	47500
4		Kuching	Sarawak	Malaysia
5		Kuala Lumpur		Malaysia	51200
6		Kuala Lumpur		Malaysia
7		Manila		Philippines	150
8		Manila		Philippines
9		Singapore		Singapore	119074
10		Singapore		Singapore	169608
11		Singapore		Singapore	529889
12		Bangkok		Thailand	10700
13		Bangkok		Thailand

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00668135
• Other Study ID Numbers: 10657
• First Posted: Apr 29, 2008
• Last Update Posted: Dec 17, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by Bayer: Erectile Dysfunction; Vardenafil
• Additional relevant MeSH terms: Erectile Dysfunction; Vardenafil Dihydrochloride

Study Results

No Results Posted as of Dec 17, 2014