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

Phase 3CompletedNCT00661115

Bayer173 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

173

Conditions

Erectile Dysfunction

Interventions

Levitra (Vardenafil, BAY38-9456)DRUG

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

PlaceboDRUG

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

Eligibility

Sex: MALEMin age: 21 Years

Medical Language ↔ Plain English

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.

Locations (6)

Unnamed facility

Bangalore, Karnataka, India

Unnamed facility

Bangalore, Karnataka, India

Unnamed facility

Belagum, Karnataka, India

Unnamed facility

Mumbai, Maharashtra, India

Unnamed facility

Outcomes

Primary Outcomes

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

Time frame: At Week 12 using the Last Observation Carried Forward (LOCF) method to account for dropouts.

Secondary Outcomes

Success in penetration and maintenance as recorded in subject diaries

Time frame: At Weeks 4, 8 and 12 (as observed and at LOCF)

Scores for questions 3 and 4 of the IIEF

Time frame: At Weeks 4, 8 and 12 (as observed and at LOCF)

Other IIEF domain scores

Time frame: At Week 12 (observed and at LOCF)

Global Assessment Question (GAQ) responses

Time frame: 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.

Time frame: At Weeks 4, 8 and 12 (as observed and at LOCF)

Data from ClinicalTrials.gov

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