Trial Condition(s):
Erectile Dysfunction
Evaluating the efficacy Vardenafil 10 mg vs Tadalafil 10 mg in in subjects with erectile dysfunction (ED)
Bayer Identifier:
11333
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
Evaluating the efficacy of 10mg vardenafil versus 10mg tadalafil in the first 45 minutes post-dosing, in an as-required regimen for 4 weeks in subjects with mild/moderate to severe ED
Inclusion Criteria
- Age between 18 and 64 years - Heterosexual males - Erectile dysfunction for more than 6 months
Exclusion Criteria
- Penile anatomical abnormalities - Spinal cord injury - History of surgical prostatectomy
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations |
|---|
Trial Design
A randomised, double-blind, double-dummy, parallel-group, active-controlled study evaluating the efficacy of vardenafil versus tadalafil when intercourse is attempted within 45 minutes of administration in subjects 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
- Sexual Encounter Profile Question 3 (SEP-3)Timeframe: 4 weeks
Secondary Outcome
- Sexual Encounter Profile Question 2 (SEP-2)Timeframe: 4 weeks
- International Index of Erectile FunctionTimeframe: 4 weeks
- Global Confidence Question (GCQ)Timeframe: 4 weeks
- Erection Quality Scale (EQS)Timeframe: 4 weeks
- General SafetyTimeframe: 4 weeks
Additional Information
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