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

NCT ID: NCT00309855

Last Updated: 2012-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Double Placebo

(i.m. vehicle 0.5 mL weekly x three injections and oral placebo once daily x 21 days)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

im and orally

Testosterone IM and oral placebo

IM injections weekly x three injections and oral placebo once daily x 21 days

Group Type OTHER

Testosterone

Intervention Type DRUG

injections

Testosterone and Oral Anastrozole

IM injections weekly x 3 injections and oral daily x 21 days

Group Type OTHER

Testosterone

Intervention Type DRUG

injections

Anastrazole

Intervention Type DRUG

orally x 21 days

Testosterone and Dutasteride

IM injections weekly x 3 injections and oral once daily x 21 days

Group Type OTHER

Testosterone

Intervention Type DRUG

injections

Dutasteride

Intervention Type DRUG

orally x 21 days

Interventions

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Placebo

im and orally

Intervention Type DRUG

Testosterone

injections

Intervention Type DRUG

Anastrazole

orally x 21 days

Intervention Type DRUG

Dutasteride

orally x 21 days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic

Principal Investigators

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Johannes D. Veldhuis, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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319-03

Identifier Type: -

Identifier Source: org_study_id