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Effect of Testosterone Replacement on Insulin Resistance

NCT00487734 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2012-10-23

No results posted yet for this study

Summary

This study aims to determine whether testosterone replacement improves insulin sensitivity in non-obese men with low testosterone and the metabolic syndrome. The metabolic syndrome includes three of the following five conditions, 1) an elevated blood pressure (greater than 130/85), 2) a triglyceride level greater than 150 mg/dl, 3) an HDL-cholesterol less than 40 mg/dl, 4) glucose levels greater than 100 mg/dl, and 5) a waist measurement greater than 40 inches.

Conditions

  • Metabolic Syndrome
  • Hypogonadism

Interventions

RADIATION

Testosterone gel

testosterone gel, applied daily. Dosed to achieve testosterone level \<500 ng/dL. Possible doses include 2.5g, 5g, 7.5g or 10g gel packets.

DRUG

Placebo for testosterone gel

Placebo gel, 2.5g for each gel packet

Sponsors & Collaborators

  • Solvay Pharmaceuticals

    collaborator INDUSTRY

  • McGuire Research Institute

    lead OTHER

Principal Investigators

  • Sonja K Fredrickson, MD · Hunter Holmes McGuire VA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States

Study Locations

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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 NCT00487734 on ClinicalTrials.gov