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.
Phase:
Phase 3
Details
Lead Sponsor:
University of Pennsylvania
Collaborators:
Abbott 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)