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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00309855
First received: March 31, 2006
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Aging
Drug: Placebo
Drug: Testosterone
Drug: Anastrazole
Drug: Dutasteride
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Mechanisms of Testosterone-Driven Growth-Hormone (GH) Secretion in Aging Men: Modulation of GHRH, GHRP and Somatostatin Action by Estrogenic Versus Androgenic Steroids

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Growth Hormone concentration after injections [ Time Frame: 24 days ] [ Designated as safety issue: No ]
    GH will be measured 4 different times mornings within 16-21 days following the first testosterone injection (day 1).


Enrollment: 80
Study Start Date: December 2005
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Double Placebo
(i.m. vehicle 0.5 mL weekly x three injections and oral placebo once daily x 21 days)
Drug: Placebo
im and orally
Testosterone IM and oral placebo
IM injections weekly x three injections and oral placebo once daily x 21 days
Drug: Testosterone
injections
Testosterone and Oral Anastrozole
IM injections weekly x 3 injections and oral daily x 21 days
Drug: Testosterone
injections
Drug: Anastrazole
orally x 21 days
Testosterone and Dutasteride
IM injections weekly x 3 injections and oral once daily x 21 days
Drug: Testosterone
injections
Drug: Dutasteride
orally x 21 days

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309855

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
GlaxoSmithKline
Investigators
Principal Investigator: Johannes D. Veldhuis, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Johannes D. Veldhuis, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00309855     History of Changes
Other Study ID Numbers: 319-03
Study First Received: March 31, 2006
Last Updated: July 27, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dutasteride
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
5-alpha Reductase Inhibitors
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on October 30, 2014