To Investigate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction.

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00661115

Collaborator

(none)

173

Enrollment

Locations

Arms

9.1

Duration (Months)

28.8

Patients Per Site

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To investigate the efficacy and safety of vardenafil in men with erectile dysfunction.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

173 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomised, Double Blind, Placebo Controlled, Multi-center, Fixed Dose, Parallel Group Study to Investigate the Efficacy and Safety of Vardenafil (BAY 38-9456) in Men With Erectile Dysfunction .

Study Start Date :

May 1, 2003

Actual Primary Completion Date :

Feb 1, 2004

Actual Study Completion Date :

Feb 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Levitra (Vardenafil, BAY38-9456) Vardenafil 10 mg. After a 4 week run-in period, subjects were randomized in order to enroll 3 times more subjects in the vardenafil group than in the placebo group. The duration of the active treatment phase was 12 weeks
Placebo Comparator: Arm 2	Drug: Placebo Placebo. After a 4 week run-in period, subjects were randomized in order to enroll 3 times more subjects in the vardenafil group than in the placebo group. The duration of the active treatment phase was 12 weeks

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: Levitra (Vardenafil, BAY38-9456)

Vardenafil 10 mg. After a 4 week run-in period, subjects were randomized in order to enroll 3 times more subjects in the vardenafil group than in the placebo group. The duration of the active treatment phase was 12 weeks

Placebo Comparator: Arm 2

Drug: Placebo

Placebo. After a 4 week run-in period, subjects were randomized in order to enroll 3 times more subjects in the vardenafil group than in the placebo group. The duration of the active treatment phase was 12 weeks

Outcome Measures

Primary Outcome Measures

Erectile function (EF) domain score of the International Index of Erectile Function (IIEF)calculated as the sum of scores from Questions 1 to 5 and 15 [At Week 12 using the Last Observation Carried Forward (LOCF) method to account for dropouts.]

Secondary Outcome Measures

Success in penetration and maintenance as recorded in subject diaries [At Weeks 4, 8 and 12 (as observed and at LOCF)]
Scores for questions 3 and 4 of the IIEF [At Weeks 4, 8 and 12 (as observed and at LOCF)]
Other IIEF domain scores [At Week 12 (observed and at LOCF)]
Global Assessment Question (GAQ) responses [At Weeks 4, 8 and 12 (as observed and at LOCF)]
Rates of premature termination, adverse events, laboratory abnormalities, ECG abnormalities, and concomitant medication use. [At Weeks 4, 8 and 12 (as observed and at LOCF)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Men 21 years or above with ED for more than 6 months with normal libido and stable heterosexual relationship of at least 6 months
having at least a 50% failure rate of sexual intercourse attempts during the run-in phase

Exclusion Criteria:

Subjects with penile abnormalities, hypogonadism, history of unstable angina pectoris for 6 months or less, myocardial infarction, life threatening arrhythmia and history of unresponsiveness to sildenafil were excluded.
Diabetic subjects with hemoglobin A1c (HbA1c) more than 12% were also excluded.
Subjects could not be on androgens/anti-androgens or alpha blockers.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Bangalore	Karnataka	India	560010
2	Bangalore	Karnataka	India	560054
3	Belagum	Karnataka	India	590010
4	Mumbai	Maharashtra	India	400007
5	Mumbai	Maharashtra	India	400022
6	Madurai	Tamilnadu	India	625107

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:

NCT00661115

Other Study ID Numbers:

10695

First Posted:

Apr 18, 2008

Last Update Posted:

Dec 16, 2014

Last Verified:

Dec 1, 2014

Keywords provided by Bayer

Erectile dysfunction

Sexual Dysfunction

Additional relevant MeSH terms:

Erectile Dysfunction

Vardenafil Dihydrochloride

Study Results

No Results Posted as of Dec 16, 2014