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Testosterone, Metformin, or Both, for Hypogonadism in Obese Males

NCT02514629 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2024-12-13

No results posted yet for this study

Summary

The purpose of this study is to examine the effects of metformin, testosterone, or both, in males with obesity-related hypogonadism. This study will evaluate changes in insulin resistance, weight loss, body composition, testosterone levels,quality of life and erectile dysfunction.

Obese men will receive diet and physical activity counselling, and be randomised to either testosterone, metformin, a combination of both or placebo

Conditions

Interventions

DRUG

Placebo

DRUG

Metformin

DRUG

Testosterone Undecanoate

DRUG

Metformin + Testosterone Undecanoate

Sponsors & Collaborators

  • Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

    lead OTHER

Principal Investigators

  • Jose Carlos Fernandez-Garcia, MD · Hospital Universitario Virgen de la Victoria. Malaga

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-07-04
Primary Completion
2016-07-12
Completion
2016-07-12

Countries

  • Spain

Study Locations

More Related Trials

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 NCT02514629 on ClinicalTrials.gov