Completed
PHASE3
INTERVENTIONAL
NCT02514629
Testosterone, Metformin, or Both, for Hypogonadism in Obese Males
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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
Interventions
Name:
Placebo
Type:
DRUG
Description:
Name:
Metformin
Type:
DRUG
Description:
Name:
Testosterone Undecanoate
Type:
DRUG
Description:
Name:
Metformin + Testosterone Undecanoate
Type:
DRUG
Description:
Primary Outcomes
Measure:
Change in Insulin Resistance
TimeFrame:
Basal-52 weeks
Description:
Insulin resistance will be measured using Homeostasis Model of Assessment for Insulin Resistance index (HOMA-IR index)
HOMA-IR=FINS\*FGLU/22.5
Trial Information
NCT ID
NCT02514629
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Last Updated
December 15, 2025