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

Leonard S. Marks, M.D.44 enrolled

Overview

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 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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Men With Low Testosterone Levels

Interventions

Testosterone EnanthateDRUG

Testosterone Enanthate

PlaceboOTHER

placebo

Eligibility

Sex: MALEMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Urological Sciences Research Foundation

Culver City, California, United States

Data from ClinicalTrials.gov

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