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Phase 3CompletedAge-related condition

The Testosterone Trials in Older Men

Randomized, Placebo-controlled, Double-blind Study of Seven Coordinated Testosterone Treatment Trials in Older Men

Sponsor
University of Pennsylvania (Academic or other)
Enrollment
790 enrolled
Conditions
Andropause
Interventions
AndroGel® (testosterone gel); Placebo
Ages
older adults
Registry
NCT00799617

Full record on ClinicalTrials.gov

From the registry

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…

Primary outcomes

  • Sexual Function Trial - Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Month 12
  • Physical Function Trial - The 6-Minute Walk Test - no./Total no. (%)
  • Vitality Trial - Increase in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score Greater Than or Equal to 4 - no./Total no. (%)
  • Cardiovascular Trial - Assess Impact of Testosterone Treatment in Older Men on Noncalcified Plaque Volume

History

  1. Last registry update

  2. Study completion

  3. Results first posted

  4. Primary completion

  5. Started

  6. Registered

Papers citing this trial