Andropause Clinical Trial
Official title:
Randomized, Placebo-controlled, Double-blind Study of Seven Coordinated Testosterone Treatment Trials in Older Men
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.
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 independence. These conditions include mobility disability and low vitality.
Elderly men also experience increased anemia, metabolic syndrome, decreased sexual function
and memory impairment. These conditions likely have multiple causes, but one cause that could
contribute to all of them is a low serum testosterone concentration. When young hypogonadal
men are treated with testosterone, they experience improvements in sexual function, muscle
mass and strength, bone mineral density, sense of well being, and anemia. However, the
benefits of testosterone therapy in older men with age-related decline in testosterone
concentration are not known and are the subject of this investigation.
Participants will be treated with testosterone or placebo gel for 1 year. The dose will be
adjusted in a blinded fashion to achieve a target T level range. Participants will be
followed for one additional year following the treatment phase to assess adverse events.
- Men participating in the Cardiovascular Trial will be assessed for changes in
atherosclerotic plaque burden from 0 to 12 months.
- Men participating in the Bone Trial will be assessed by QCT of the spine and hip, DXA of
the spine and hip and clinical fractures at 0 and 12 months.
- Men participating in the PK Study will attend 3 additional study visits for blood draws
at the time of the 4-month assessment.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02943356 -
Effect of Tadalafil on Erectile Dysfunction Treatment and QOL Improvement Effect (by SF-12) in Andropause Patients With Erectile Dysfunction
|
Phase 4 |