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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00202163
First Posted: September 20, 2005
Last Update Posted: January 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Joe Downey, Queen's University
  Purpose
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.

Condition Intervention Phase
Erectile Dysfunction Drug: DHEA Drug: Testosterone Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Joe Downey, Queen's University:

Primary Outcome Measures:
  • Patient satisfaction

Secondary Outcome Measures:
  • Responder rates based upon questionnaires

Estimated Enrollment: 120
Study Start Date: December 2006
Study Completion Date: September 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Erectile dysfunction (ED)

Exclusion Criteria:

  • Prior use of DHEA or T
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202163


Locations
Canada, Ontario
Centre for Advanced Urological Research
Kingston, Ontario, Canada, K7L 3N6
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Alvaro Morales, MD FRCSC Queen's University
  More Information

Responsible Party: Joe Downey, Centre Administrator, Queen's University
ClinicalTrials.gov Identifier: NCT00202163     History of Changes
Other Study ID Numbers: DHEA-RCT
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: January 13, 2016
Last Verified: January 2016

Keywords provided by Joe Downey, Queen's University:
ED
DHEA
testosterone

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Dehydroepiandrosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Adjuvants, Immunologic
Immunologic Factors