Overview

Testosterone-Driven Growth-Hormone (GH) Secretion in Aging Men

Status:
Completed
Trial end date:
2008-08-01
Target enrollment:
0
Participant gender:
Male
Summary
This study is being done to understand how testosterone, the major male sex hormone, controls the pituitary gland's secretion of growth hormone (GH). GH is an important metabolic hormone, which controls sugar; fat and protein use in the body and maintains muscle strength and bone calcium content. Both testosterone and GH decline in older men. The age-related fall in these hormones probably contributes to relative frailty, reduced quality of life, bone loss, muscle wasting and impaired sexual function.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Mayo Clinic
Collaborator:
GlaxoSmithKline
Treatments:
Anastrozole
Dutasteride
Hormones
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Criteria
Inclusion Criteria:

- healthy men between the ages of 50 and 80;

- normal weight (within 30% of ideal body weight defined by New York Metropolitan Life
tables); and

- normal hematocrit (greater than 38%);

- community dwelling; and

- voluntarily consenting

Exclusion Criteria:

- recent use of psychotropic or neuroactive drugs (within five biological half-live);

- obesity (outside weight range above);

- anemia (hematocrit < 38%);

- drug or alcohol abuse, psychosis, depression, mania or severe anxiety;

- acute or chronic organ-system disease;

- endocrinopathy, other than primary thyroidal failure receiving replacement;

- nightshift work or recent transmeridian travel (exceeding 3 time zones within 7 days
of admission);

- acute weight change (loss or gain of > 2 kg in 6 weeks);

- allergy to administered compounds; and

- unwillingness to provide written informed consent.