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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00161304
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : September 12, 2005
Solvay Pharmaceuticals
Watson Pharmaceuticals
Information provided by:
Urological Sciences Research Foundation

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.

Condition or disease Intervention/treatment Phase
Men With Low Testosterone Levels Drug: Testosterone Enanthate Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effects of Testosterone Administration on Tissues of Men With A.D.A.M. (Androgen Deficiency of Aging Men)
Study Start Date : April 2003
Study Completion Date : November 2004

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00161304

United States, California
Urological Sciences Research Foundation
Culver City, California, United States, 90232
Sponsors and Collaborators
Urological Sciences Research Foundation
Solvay Pharmaceuticals
Watson Pharmaceuticals
Principal Investigator: Leonard S Marks, M.D. Urological Sciences Research Foundation

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00161304     History of Changes
Other Study ID Numbers: T-001
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: September 12, 2005
Last Verified: November 2004

Additional relevant MeSH terms:
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents