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Dose-Response of Gonadal Steroids and Bone Turnover in Older Men

NCT00114114 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2019-10-08

Study results available
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Summary

The purpose of this study is to determine the levels of testosterone and/or estradiol at which changes in bone turnover, body composition, strength, sexual function etc. begin to occur in older men. This information may help determine when to intervene with hormone replacement therapy in aging men.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Testosterone

Androgel placebo or 1.25, 2.5, 5. or 10\* gms topically each day

DRUG

Goserelin acetate

3.6 gms sc every 4 weeks

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Solvay Pharmaceuticals

    collaborator INDUSTRY

  • AstraZeneca

    collaborator INDUSTRY

  • AbbVie

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Ben Z Leder, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2017-11-01
Completion
2017-11-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00114114 on ClinicalTrials.gov