The Testosterone Trial in Older Men
What is the purpose of this trial?
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.
- 65 Years and older
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Aging (NIA)
University of Pennsylvania
- November 2009
- Last Updated:
- January 10, 2012
- Study HIC#:
Clinicaltrials.gov ID: NCT00799617