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

NCT ID: NCT00202163

Last Updated: 2016-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-09-30

Brief Summary

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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

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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.

Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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DHEA

Intervention Type DRUG

Testosterone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Erectile dysfunction (ED)

Exclusion Criteria

* Prior use of DHEA or T
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen's University

OTHER

Sponsor Role lead

Responsible Party

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Joe Downey

Centre Administrator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alvaro Morales, MD FRCSC

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

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Centre for Advanced Urological Research

Kingston, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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DHEA-RCT

Identifier Type: -

Identifier Source: org_study_id

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