Status:
COMPLETED
The Testosterone Trials in Older Men
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute on Aging (NIA)
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Andropause
Eligibility:
MALE
65+ years
Phase:
PHASE3
Brief Summary
The Testosterone Trials are a multi-center set of trials involving 12 clinical sites geographically distributed across the United States. The primary specific aims are to test the hypotheses that tes...
Detailed Description
As men get older, they experience many conditions, often together, that eventually result in the inability to perform many activities of daily living, an increased propensity to fall, and decreased in...
Eligibility Criteria
Inclusion
- Men greater than or equal to 65 years old
- Total serum testosterone concentration \< 275 and \< 300 ng/dL at 7 -10 AM at each of two screening visits
Exclusion
- Diagnosed prostate cancer, prostatic intraepithelial neoplasia (PIN), prostate nodule or, by the Prostate Cancer Risk Calculator, a \>35% risk of having overall prostate cancer or \>7% risk of having high grade prostate cancer
- Severe lower urinary tract symptoms (score of \> 19) by the International Prostate Symptom Score questionnaire
- Hemoglobin \<10 g/dL or \>16.0 g/dL
- Sleep apnea, diagnosed but untreated
- Alcohol or substance abuse within the past year (based on self report)
- Angina not controlled by treatment
- NYHA class III or IV congestive heart failure
- Myocardial infarction within the previous 3 months before entry
- Stroke within the previous 3 months before entry
- Severe pulmonary disease that precludes physical function tests
- Serum creatinine \>2.2 mg/dL; ALT 3x upper limit of normal; hemoglobin A1c \>8.5%, TSH \> 7.5mIU/L
- Diagnosis or treatment for cancer within the past 3 years, with the exception of nonmelanotic skin cancer
- Body mass index (BMI) \>37 kg/m2
- Mini Mental State Exam (MMSE) Score \<24
- Major psychiatric disorders, including major depression (PHQ-9 score \> 14), mania, hypomania, psychosis, schizophrenia or schizoaffective disorders, that are untreated, unstable, have resulted in hospitalization or medication change within the previous three months, or would result in inability to complete the trial efficacy instruments. Subjects whose disorders have been stable while being treated for more than three months are eligible.
- Use of the following medications within the previous three months:
- drugs that affect serum testosterone concentration
- rhGH or megestrol acetate
- introduction of anti-depressant medication
- daily use of prednisone for more than two weeks
- Opiate use within the past three months
- Skin conditions at the testosterone gel application site, such as ulcer, erosion, lichenification, inflammation, or crust, or generalized skin conditions such as psoriasis or eczema that might affect testosterone absorption or tolerability of the testosterone gel
- Known skin intolerance to alcohol or allergy to any of the ingredients of testosterone gel
- Participants in the T Trial may also enroll in the Cardiovascular and Bone Trials if it is determined that they are eligible based on the specific exclusion criteria.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
790 Patients enrolled
Trial Details
Trial ID
NCT00799617
Start Date
November 1 2009
End Date
December 1 2018
Last Update
February 21 2019
Active Locations (12)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of California San Diego
La Jolla, California, United States, 92093
3
Center for Men's Health LA BioMed at Harbor-UCLA Medical Center
Torrance, California, United States, 90501
4
Yale University
New Haven, Connecticut, United States, 06520