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The Effects of Long Term Cyclic Testosterone Administration on Muscle Function and Bone in Older Men

NCT01417364 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2015-10-02

No results posted yet for this study

Summary

The general hypothesis is that administration of testosterone to healthy, older men for 52 weeks (1 year) following a cycle of 4 weeks of testosterone administration and 4 weeks without testosterone (i.e., monthly cycled regimen) will provide the same gains in muscle strength, muscle mass, and bone density as standard of care (SOC), continuous administration of testosterone for 52 weeks.

Conditions

Interventions

DRUG

Testosterone enanthate

100 mg. IM weekly throughout study

DRUG

Testosterone enanthate

100 mg IM weekly for one month alternating with placebo injections for one month throughout the study

DRUG

Placebo

Injected IM weekly throughout study

Sponsors & Collaborators

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-12-31
Completion
2017-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT01417364 on ClinicalTrials.gov