NCT00202163

ANDRO 2002: Dehydroepiandrosterone (DHEA) or Testosterone Versus Placebo in Men With Sexual Dysfunction

A Randomized Double-Blind Placebo-Controlled Study Comparing the Safety and Efficacy of Dehydroepiandrosterone (DHEA) or Testosterone Versus Placebo in Men With Sexual Dysfunction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Queen's University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	DHEA
DRUG	Testosterone

Timeline

• Start date: 2006-12-01
• Primary completion: 2007-07-01
• Completion: 2007-09-01
• First posted: 2005-09-20
• Last updated: 2016-01-13

Locations

1 site across 1 country: Canada