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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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.
Repletion of testosterone in older men drives pulsatile GH secretion via conjoint facilitation of feedforward by the primary secretagogues GHRH and GHRP and repression of feedback by the dominant inhibitor, somatostatin; and, in corollary, testosterone acts via aromatization to estradiol and/or reduction to 5 alpha-dihydrotestosterone
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double Placebo | Placebo Comparator | (i.m. vehicle 0.5 mL weekly x three injections and oral placebo once daily x 21 days) |
|
| Testosterone IM and oral placebo | Other | IM injections weekly x three injections and oral placebo once daily x 21 days |
|
| Testosterone and Oral Anastrozole | Other | IM injections weekly x 3 injections and oral daily x 21 days |
|
| Testosterone and Dutasteride | Other | IM injections weekly x 3 injections and oral once daily x 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | im and orally |
| |
| Testosterone |
| Measure | Description | Time Frame |
|---|---|---|
| Growth Hormone concentration after injections | GH will be measured 4 different times mornings within 16-21 days following the first testosterone injection (day 1). | 24 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johannes D. Veldhuis, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| D000077384 | Anastrozole |
| D000068538 | Dutasteride |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Drug |
injections |
|
| Anastrazole | Drug | orally x 21 days |
|
| Dutasteride | Drug | orally x 21 days |
|
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001378 | Azasteroids |
| D013260 | Steroids, Heterocyclic |