CompletedPhase 3

The Testosterone Trials in Older Men

United States790 participantsStarted 2009-11

Plain-language 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 testosterone treatment of elderly men whose serum testosterone concentrations are unequivocally low - and who have symptoms and objectively measured abnormalities in at least one of five areas that could be due to low testosterone (physical or sexual function, vitality, cognition, and anemia) - will result in more favorable changes in those abnormalities than placebo treatment. Two additional trials have been incorporated into the T Trial. Only men enrolled in the T Trial are eligible to participate in these trials. * The Cardiovascular Trial will examine if testosterone treatment results in more favorable changes in cardiovascular risk factors, compared to placebo. * The Bone Trial will test the hypothesis that testosterone treatment will increase volumetric trabecular bone mineral density (vBMD) of the lumbar spine as measured by quantitative computed tomography (QCT), compared with placebo treatment. A Pharmacokinetic (PK) Study is also being conducted within the context of the interventional T Trial. It will examine the variability of the serum testosterone (T) concentration after application of testosterone gel or placebo, four months after the start of treatment.

Who can participate

Age range65 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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 t…

What they're measuring

Sexual Function Trial - Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Month 12

Timeframe: 1 year (change from baseline to month 3, 6, 9 and 12)

Physical Function Trial - The 6-Minute Walk Test - no./Total no. (%)

Timeframe: 1 year (Number of participants who increased walk distance > or = 50 meters, change from baseline to month 3, 6, 9 and 12)

Vitality Trial - Increase in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score Greater Than or Equal to 4 - no./Total no. (%)

Timeframe: 1 year (Number of participants who increased FACIT-Fatigue score > or = to 4, change from baseline to month 3, 6, 9 and 12)

Cardiovascular Trial - Assess Impact of Testosterone Treatment in Older Men on Noncalcified Plaque Volume

Timeframe: 1 year (change in plaque volume measurement from baseline to month 12)

Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Trabecular Bone by Quantitative Computed Tomography (QCT) in Older Men With Low Testosterone

Timeframe: 1 year (QCT measurement of BMD change between baseline and month 12)

Cognitive Function Trial - Delayed Paragraph Recall Wechsler Memory Scale Revised Logical Memory II (WMS-R LMII)

Timeframe: 1 year (change from baseline to month 6 and month 12)

Trial details

NCT IDNCT00799617

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-07

Results submitted2017-01-03

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