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

Leonard S. Marks, M.D.

Status and phase: Completed; Phase 3; Phase 2

Conditions: Men With Low Testosterone Levels

Treatments: Other: Placebo; Drug: Testosterone Enanthate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00161304

T-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: Male

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups, including a placebo group

Testosterone Enanthate

Active Comparator group

Description:

Testosterone

Treatment:

Drug: Testosterone Enanthate

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo