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Testosterone Replacement in Metabolic Syndrome and Inflammation

NCT01123278 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2014-10-28

No results posted yet for this study

Summary

Hypogonadism (HG) frequently complicates the Metabolic Syndrome (MetS), whether testosterone replacement (TRT) is beneficial has not been clearly ascertained. This study was designed to address the effects of TRT on insulin resistance, body composition and pro-inflammatory status in naïve patients with MetS and HG.

Conditions

Interventions

DRUG

Testosterone

Testosterone transdermal gel 50 mg/day (5 gr)

DRUG

Placebo

Placebo transdermal gel (5 gr)

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Principal Investigators

  • Vincenzo Bonifacio, MD, PhD · University of Roma La Sapienza

  • Andrea M Isidori, MD, PhD · University of Roma La Sapienza

  • Andrea Lenzi, MD, PhD · University of Roma La Sapienza

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Italy

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 NCT01123278 on ClinicalTrials.gov