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

This study has been completed.
Sponsor:
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00202163
First received: September 13, 2005
Last updated: April 21, 2008
Last verified: April 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

Further study details as provided by 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Erectile dysfunction (ED)

Exclusion Criteria:

  • Prior use of DHEA or T
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Alvaro Morales, Queen's University
ClinicalTrials.gov Identifier: NCT00202163     History of Changes
Other Study ID Numbers: DHEA-RCT
Study First Received: September 13, 2005
Last Updated: April 21, 2008
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
ED
DHEA
testosterone

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

ClinicalTrials.gov processed this record on May 21, 2013