Study to Determine the Effects of Testosterone Replacement Therapy in Aging Men With Androgen Deficiency

April 26, 2021 updated by: Leonard S. Marks, M.D.

Effects of Testosterone Administration on Tissues of Men With A.D.A.M. (Androgen Deficiency of Aging Men)

The T-001 study is a placebo-controlled investigation of the effects of injectable testosterone replacement therapy on prostate tissues of aging men with low testosterone levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The T-001 study is a placebo-controlled investigation of the effects of injectable testosterone replacement therapy on prostate tissues of aging men with low testosterone levels. The primary objectives of the study are to measure the changes in tissue hormones and other biomarkers in the prostate tissue specimens.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Culver City, California, United States, 90232
        • Urological Sciences Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

The screening evaluation consisted of:

  1. medical history, which included the androgen deficiency of the aging male questionnaire
  2. physical examination
  3. multiphasic serum panel
  4. measurement of total serum testosterone and PSA levels

Exclusion criteria included:

  1. use in the past 6 months of any drug potentially affecting the pituitary-gonadal axis
  2. serum PSA level greater than 10.0 ng/mL
  3. refusal or inability to undergo prostate biopsies
  4. presence of prostate cancer on initial biopsy results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
placebo
Active Comparator: Testosterone Enanthate
Testosterone
Drug: Testosterone Enanthate
Testosterone Enanthate
Other Names:
  • testosterone

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leonard S. Marks, M.D.

Collaborators

Watson Pharmaceuticals
Solvay Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2003

Primary Completion (Actual)

August 1, 2004

Study Completion (Actual)

November 1, 2004

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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