Trial | NCT00161304  Report issue

Title

Study to Determine the Effects of Testosterone Replacement Therapy in Aging Men With Androgen Deficiency
Effects of Testosterone Administration on Tissues of Men With A.D.A.M. (Androgen Deficiency of Aging Men)

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    testosterone ...

  • Study Participants

    44
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 Started
Apr 30
2003
Primary Completion
Aug 31
2004
Study Completion
Nov 30
2004
Last Update
Apr 28
2021

Drug Testosterone Enanthate

Testosterone Enanthate

  • Other names: testosterone

Other Placebo

placebo

Testosterone Enanthate Active Comparator

Testosterone

Placebo Placebo Comparator

Placebo

Criteria 

The screening evaluation consisted of:

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

Exclusion criteria included:

use in the past 6 months of any drug potentially affecting the pituitary-gonadal axis
serum PSA level greater than 10.0 ng/mL
refusal or inability to undergo prostate biopsies
presence of prostate cancer on initial biopsy results.
No Results Posted