Trial Condition(s):
Erectile Dysfunction
To investigate the efficacy and safety of vardenafil in men with erectile dysfunction.
Bayer Identifier:
10695
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
To investigate the efficacy and safety of vardenafil in men with erectile dysfunction.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Mumbai, India, 400007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Belagum, India, 590010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madurai, India, 625107 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mumbai, India, 400022 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bangalore, India, 560010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bangalore, India, 560054 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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 .
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- 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 15Timeframe: At Week 12 using the Last Observation Carried Forward (LOCF) method to account for dropouts.
Secondary Outcome
- Success in penetration and maintenance as recorded in subject diariesTimeframe: At Weeks 4, 8 and 12 (as observed and at LOCF)
- Scores for questions 3 and 4 of the IIEFTimeframe: At Weeks 4, 8 and 12 (as observed and at LOCF)
- Other IIEF domain scoresTimeframe: At Week 12 (observed and at LOCF)
- Global Assessment Question (GAQ) responsesTimeframe: 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.Timeframe: At Weeks 4, 8 and 12 (as observed and at LOCF)
Additional Information
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