A pilot, randomized, double-blind, placebo-controlled, crossoverstudy evaluating the efficacy and safety of Vardenafil versusplacebo administered 12, 18 and 24 hours prior to initiation ofsexual intercourse in subjects with ED.
- Conditions
- MedDRA version: 6.1Level: PTClassification code 10061461ERECTILE DISFUNCTION
- Registration Number
- EUCTR2004-001549-13-IT
- Lead Sponsor
- GLAXO SMITHKLINE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 314
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method