ANDRO 2002: Dehydroepiandrosterone (DHEA) or Testosterone Versus Placebo in Men With Sexual Dysfunction
Information source: Queen's University
Information obtained from ClinicalTrials.gov on August 06, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction
Intervention: DHEA (Drug); Testosterone (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Queen's University Official(s) and/or principal investigator(s):
Alvaro Morales, MD FRCSC, Principal Investigator, Affiliation: Queen's University
Overall contact:
Alvaro Morales, MD FRCSC, Phone: 613 548-2424, Email: moralesa@post.queenu.ca
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.
Clinical Details
Official title:
A Randomized Double Blind Placebo-Controlled Study Comparing the Safety and Efficacy of Dehydroepiandrosterone (DHEA) or Testosterone Versus Placebo in Men With Sexual Dysfunction
Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Patient satisfaction
Secondary outcome: Responder rates based upon questionnaires
Detailed description:
120 men with a diagnosis of 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.
Eligibility
Minimum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Erectile dysfunction (ED)
Exclusion Criteria:
- Prior use of DHEA or T
Locations and Contacts
Alvaro Morales, MD FRCSC, Phone: 613 548-2424, Email: moralesa@post.queenu.ca
Centre for Advanced Urological Research, Kingston, Ontario K7L 3N6, Canada; Recruiting
Alvaro Morales, MD FRCSC, Phone: 613 548-2424, Email: moralesa@post.queensu.ca
Additional Information
Starting date:
July 2002
Ending date: September 2006
Last updated: September 12, 2006
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