NCT00202163

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.2 years until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

January 13, 2016

Status Verified

January 1, 2016

Enrollment Period

7 months

First QC Date

September 13, 2005

Last Update Submit

January 12, 2016

Conditions

Erectile Dysfunction

Keywords

EDDHEAtestosterone

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction

Secondary Outcomes (1)

  • Responder rates based upon questionnaires

Interventions

DHEADRUG
TestosteroneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Erectile dysfunction (ED)

You may not qualify if:

  • Prior use of DHEA or T

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Advanced Urological Research

Kingston, Ontario, K7L 3N6, Canada

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

DehydroepiandrosteroneTestosterone

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds17-KetosteroidsKetosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsTestosterone CongenersGonadal Steroid HormonesGonadal Hormones

Study Officials

  • Alvaro Morales, MD FRCSC

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Centre Administrator

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

December 1, 2006

Primary Completion

July 1, 2007

Study Completion

September 1, 2007

Last Updated

January 13, 2016

Record last verified: 2016-01

Locations

CA(1)