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5-Alpha Reductase and Anabolic Effects of Testosterone

NCT00475501 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-10-11

Study results available
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Summary

The purpose of this study is to determine whether a higher-than-replacement dose of testosterone and finasteride can be combined to safely increase muscle strength in older men who have a low blood concentration of testosterone.

Conditions

  • Male Hypogonadism
  • Muscle Atrophy
  • Sarcopenia
  • Benign Prostate Hypertrophy

Interventions

DRUG

Testosterone Enanthate

125 mg, i.m. injection, once/week, for 52 weeks

DRUG

Finasteride

5 mg, oral, once/day, for 52 weeks

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Endo Pharmaceuticals

    collaborator INDUSTRY

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Stephen Borst, PhD · North Florida/South Georgia Veterans Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2012-03-31
Completion
2014-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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 NCT00475501 on ClinicalTrials.gov