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

Overview[ - collapse ][ - ]

Purpose 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.
ConditionMen With Low Testosterone Levels
InterventionDrug: Testosterone Enanthate
PhasePhase 2/Phase 3
SponsorUrological Sciences Research Foundation
Responsible PartyUrological Sciences Research Foundation
ClinicalTrials.gov IdentifierNCT00161304
First ReceivedSeptember 8, 2005
Last UpdatedSeptember 11, 2005
Last verifiedNovember 2004

Tracking Information[ + expand ][ + ]

First Received DateSeptember 8, 2005
Last Updated DateSeptember 11, 2005
Start DateApril 2003
Estimated Primary Completion DateNovember 2004
Current Primary Outcome MeasuresNot Provided
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleStudy to Determine the Effects of Testosterone Replacement Therapy in Aging Men With Androgen Deficiency
Official TitleEffects of Testosterone Administration on Tissues of Men With A.D.A.M. (Androgen Deficiency of Aging Men)
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. The primary objectives of the study are to measure the changes in tissue hormones
and other biomarkers in the prostate tissue specimens.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 2/Phase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
ConditionMen With Low Testosterone Levels
InterventionDrug: Testosterone Enanthate
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment44
Estimated Completion DateNovember 2004
Estimated Primary Completion DateNot Provided
Eligibility Criteria
Inclusion Criteria:Inclusion Criteria

1. Male aged 50-80 years of age, ambulatory, and in good general physical and mental
health.

2. Clinical diagnosis of hypogonadism defined as a serum testosterone level less than
300 ng/dl on a morning serum sample during the screening period.

3. Answering yes to question 1 or 7 or to any three questions total on the Morley index
at baseline.

4. PSA <10 ng/ml

5. Subject is able to give informed consent.

Exclusion Criteria

1. Failure to meet the criteria for inclusion

2. History of allergy to testosterone or any components of the delivery system.

3. Significant abnormalities on pre-study clinical examination or laboratory
measurements.

4. Treatment with any investigational drug during the previous month.

5. Drug or alcohol abuse or dependence.

6. Concurrent use of testosterone and or any hormonal therapy, including health food
supplements and herbal products, that could alter serum testosterone levels or affect
the prostate (e.g. gonadotropic releasing hormone agonists, testosterone antagonists,
anabolic steroids, DHEA, androstenedione, PC-SPES, chrysin and tribulus terrestris,).
Use of alpha-reductase inhibitors or prostate phytotherapy within the past 3 months.

7. Use of antidepressant medications, oral glucocorticoids, or opioids.

8. PSA > 10 ng/ml and/or prostate biopsy positive for cancer at screening. Any patient
in whom there is a suspicion of prostate cancer must undergo appropriate testing to
rule out cancer prior to entry into the study.

9. IPSS score  20.

10. History of malignancy of any type (except basal cell carcinoma).

11. Patients with uncontrolled diabetes.

12. Patients with known or suspected bleeding disorder. Concurrent use of Coumadin and
other anticoagulants at the time of biopsy or if discontinuation of such therapy
prior to biopsy poses a risk to the patient.

13. Inability of the patient to provide written informed consent for any reason,
including legal incompetence, language or comprehension difficulty, and
psychological, psychiatric or emotional factors.

14. Inability of the patient to have transrectal ultrasonography with biopsy (for any
reason).

15. A history of any illness or condition that, in the opinion of the investigator, might
confound the results of the study or pose additional risk to the patient.
GenderMale
Ages50 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00161304
Other Study ID NumbersT-001
Has Data Monitoring CommitteeNot Provided
Information Provided ByUrological Sciences Research Foundation
Study SponsorUrological Sciences Research Foundation
CollaboratorsSolvay Pharmaceuticals
Watson Pharmaceuticals
Investigators Principal Investigator: Leonard S Marks, M.D. Urological Sciences Research Foundation
Verification DateNovember 2004

Locations[ + expand ][ + ]

Urological Sciences Research Foundation
Culver City, California, United States, 90232