Assessment of Efficacy of Vardenafil, Influence on Self-esteem and Self-confidence in Subjects With Erectile Dysfunction

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00661596
• Collaborator: (none)
• Enrollment: 129
• Locations: 13
• Arms: 2
• Duration (Months): 8
• Patients Per Site: 9.9
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

Erectile problems may lead to anxiety, loss of self-esteem and depression and/or stress. The purpose of this national study was to determine if vardenafil is effective in treating impotent men (erectile dysfunction) and evaluate its influence in self-esteem and self-confidence. During the visits the patients was asked some questions about erections, and he fill different questionnaires about sexuality, mood, feelings, self-esteem and sexual activity.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: Levitra (Vardenafil, BAY38-9456); Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 129 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Multi-centre, Randomised, Double-blind, Parallel, Placebo-controlled Clinical Study to Assess the Efficacy of Vardenafil and Its Influence on Self-esteem and Self-confidence in Patients With Erectile Dysfunction
• Study Start Date: May 1, 2003
• Actual Primary Completion Date: Jan 1, 2004
• Actual Study Completion Date: Jan 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Levitra (Vardenafil, BAY38-9456); 5 mg, 10 mg and 20 mg one hour prior to sexual intercourse
Placebo Comparator: Arm 2	Drug: Placebo; Matching placebo

Outcome Measures

Primary Outcome Measures

1. International Index of Erectile Function - Erectile Function Domain [12 weeks]

Secondary Outcome Measures

1. Global Assessment Questionnaire [12 weeks]

2. IIEF-EF domain score [12 weeks]

3. Other diary based variables [12 weeks]

4. Safety and tolerability [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age: 18 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 acc. to Summary of Product Characteristics

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Oviedo	Asturias	Spain	33006
2		Sabadell	Barcelona	Spain	08208
3		Barcelona	Cataluña	Spain	08025
4		Hondarribia	Guipuzcoa	Spain	28280
5		Leganés	Madrid	Spain	28911
6		Móstoles	Madrid	Spain	28935
7		Vigo	Pontevedra	Spain	36211
8		Alicante		Spain	03010
9		Granada		Spain	18003
10		Málaga		Spain	29010
11		Sevilla		Spain	41071
12		Valencia		Spain	46014
13		Valladolid		Spain	47011

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: NCT00661596
• Other Study ID Numbers: 11139
• First Posted: Apr 18, 2008
• Last Update Posted: Dec 30, 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 30, 2014