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

L

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

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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