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

Sponsor

Leonard S. Marks, M.D. (Other)

Overall Status

Completed

CT.gov ID

NCT00161304

Collaborator

Solvay Pharmaceuticals (Industry), Watson Pharmaceuticals (Industry)

Enrollment

Location

Arms

19.1

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Men With Low Testosterone Levels	Drug: Testosterone Enanthate Other: Placebo	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2003

Actual Primary Completion Date :

Aug 1, 2004

Actual Study Completion Date :

Nov 1, 2004

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Testosterone Enanthate

Testosterone

Drug: Testosterone Enanthate

Testosterone Enanthate

Other Names:

testosterone

Placebo Comparator: Placebo

Placebo

Other: Placebo

placebo

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.