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

This study has been completed.
Sponsor:
Collaborators:
Solvay Pharmaceuticals
Watson Pharmaceuticals
Information provided by:
Urological Sciences Research Foundation
ClinicalTrials.gov Identifier:
NCT00161304
First received: September 8, 2005
Last updated: September 11, 2005
Last verified: November 2004
  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.


Condition Intervention Phase
Men With Low Testosterone Levels
Drug: Testosterone Enanthate
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effects of Testosterone Administration on Tissues of Men With A.D.A.M. (Androgen Deficiency of Aging Men)

Resource links provided by NLM:


Further study details as provided by Urological Sciences Research Foundation:

Estimated Enrollment: 44
Study Start Date: April 2003
Estimated Study Completion Date: November 2004
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161304

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

Additional Information:
No publications provided by Urological Sciences Research Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00161304     History of Changes
Other Study ID Numbers: T-001
Study First Received: September 8, 2005
Last Updated: September 11, 2005
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 27, 2014