Back to resultsANDRO 2002: Dehydroepiandrosterone (DHEA) or Testosterone Versus Placebo in Men With Sexual Dysfunction
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
DHEA
Testosterone
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring ED, DHEA, testosterone
Eligibility Criteria
Inclusion Criteria: Erectile dysfunction (ED) Exclusion Criteria: Prior use of DHEA or T
Sites / Locations
- Centre for Advanced Urological Research
Outcomes
Primary Outcome Measures
Patient satisfaction
Secondary Outcome Measures
Responder rates based upon questionnaires
Full Information
NCT ID
NCT00202163
First Posted
September 13, 2005
Last Updated
January 12, 2016
Sponsor
Queen's University
1. Study Identification
Unique Protocol Identification Number
NCT00202163
Brief Title
ANDRO 2002: Dehydroepiandrosterone (DHEA) or Testosterone Versus Placebo in Men With Sexual Dysfunction
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 Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
ED, DHEA, testosterone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
DHEA
Intervention Type
Drug
Intervention Name(s)
Testosterone
Primary Outcome Measure Information:
Title
Patient satisfaction
Secondary Outcome Measure Information:
Title
Responder rates based upon questionnaires
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Erectile dysfunction (ED)
Exclusion Criteria:
Prior use of DHEA or T
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alvaro Morales, MD FRCSC
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Advanced Urological Research
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
ANDRO 2002: Dehydroepiandrosterone (DHEA) or Testosterone Versus Placebo in Men With Sexual Dysfunction
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