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Sponsored by: |
Queen's University |
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Information provided by: | Queen's University |
ClinicalTrials.gov Identifier: | NCT00202163 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
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) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
Centre for Advanced Urological Research | |
Kingston, Ontario, Canada, K7L 3N6 |
Principal Investigator: | Alvaro Morales, MD FRCSC | Queen's University |
Responsible Party: | Queen's University ( Dr. Alvaro Morales ) |
Study ID Numbers: | DHEA-RCT |
Study First Received: | September 13, 2005 |
Last Updated: | April 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00202163 History of Changes |
Health Authority: | Canada: Health Canada |
ED DHEA testosterone |
Sexual Dysfunctions, Psychological Immunologic Factors Antineoplastic Agents, Hormonal Hormone Antagonists Adjuvants, Immunologic Hormones, Hormone Substitutes, and Hormone Antagonists Dehydroepiandrosterone Methyltestosterone Genital Diseases, Male |
Hormones Testosterone 17 beta-cypionate Anabolic Agents Testosterone Sexual Dysfunction, Physiological Mental Disorders Erectile Dysfunction Androgens |
Sexual Dysfunctions, Psychological Immunologic Factors Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Adjuvants, Immunologic Hormones, Hormone Substitutes, and Hormone Antagonists Dehydroepiandrosterone Methyltestosterone Genital Diseases, Male Sexual and Gender Disorders |
Hormones Pharmacologic Actions Testosterone 17 beta-cypionate Anabolic Agents Testosterone Sexual Dysfunction, Physiological Mental Disorders Therapeutic Uses Erectile Dysfunction Androgens |