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Trial record 67 of 235 for:    PRASTERONE

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

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. Identifier: NCT00202163
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : January 13, 2016
Information provided by (Responsible Party):
Joe Downey, Queen's University

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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: DHEA Drug: Testosterone Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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
Study Start Date : December 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Patient satisfaction

Secondary Outcome Measures :
  1. Responder rates based upon questionnaires

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Erectile dysfunction (ED)

Exclusion Criteria:

  • Prior use of DHEA or T

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 identifier (NCT number): NCT00202163

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

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Responsible Party: Joe Downey, Centre Administrator, Queen's University Identifier: NCT00202163     History of Changes
Other Study ID Numbers: DHEA-RCT
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016
Keywords provided by Joe Downey, Queen's University:
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Adjuvants, Immunologic
Immunologic Factors