ANDRO 2002: Dehydroepiandrosterone (DHEA) or Testosterone Versus Placebo in Men With Sexual Dysfunction
Phase 2
Completed
- Conditions
- Erectile Dysfunction
- Registration Number
- NCT00202163
- Lead Sponsor
- Queen's University
- Brief Summary
Androgen deficiency in the aging male is poorly understood. The objective of this study will be to determine the role of testosterone and DHEA in enhancing sexual interest and sexual performance.
- Detailed Description
120 men with a diagnosis of Erectile dysfunction (ED) will be randomized to one of three arms in the study, DHEA (50 mg), testosterone \[T\] (80 mg) or placebo. Patients will be evaluated after starting blinded medication at 30 day intervals for a total of 90 days. Response will be evaluated with blood parameters, physical examination including rectal examination, validated questionnaires and global assessment scales.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- Erectile dysfunction (ED)
Exclusion Criteria
- Prior use of DHEA or T
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Patient satisfaction
- Secondary Outcome Measures
Name Time Method Responder rates based upon questionnaires
Trial Locations
- Locations (1)
Centre for Advanced Urological Research
🇨🇦Kingston, Ontario, Canada