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Testosterone, Metformin, or Both, for Hypogonadism in Obese Males | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

Randomized, Double-blind, Parallel, Placebo-controlled, Clinical Trial to Assess the Efficacy of Testosterone, Metformin, or Both, for the Treatment of Obesity-induced Male Hypogonadism

NCT02514629•Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 50 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Men aged 18 to 50 years.
•BMI \> or = 30 kg/m2.
•Total testosterone levels \<2.3 ng/ml (\<8 nmol/l) or testosterone levels 2.3-3.49 ng/ml (8-12 nmol/l) and free testosterone levels \<70 pg/ml.
•LH levels \<7.7 mIU / ml.
•No evidence of any other pituitary hormone disruption in morning blood sample (normal concentrations of TSH, FT4, Prolactin, ACTH, cortisol and IGF-1
•Being able to provide informed consent before randomization and agree to comply with all the procedures included in the protocol.

Exclusion Criteria

•Intolerance/allergy to metformin or testosterone undecanoate.
•Previous diagnosis of diabetes mellitus (HbA1c\> 6.5% or fasting glucose\> 126 mg/dl or glucose\> 200 mg/dl after an oral glucose tolerance test)
•Treatment with oral hypoglycemic agents, insulin or GLP-1 analogs.
•Poor kidney function: serum creatinine\> 2.0 mg / dl.
•Previous history of prostate cancer or breast cancer.
•Active cancer of any kind.
•History of liver tumor or acute or chronic liver disease with impaired liver function: total bilirubin\> 2.0 mg / dl or GOT levels three times the upper limit of normal.
•Central hypogonadism of organic cause
•Use in the past 12 months of any drug that affects the pituitary-gonadal axis.
•Use of oral testosterone, oral or transdermal within 2 weeks prior to study entry, or any testosterone ester in the last 6 weeks or testosterone undecanoate injection in the 6 months prior to study entry.
+15 more criteria

Locations (1)

Hospital Uiversitario Virgen de la Victoria

Málaga, Malaga, Spain

Key Dates

Start Date

July 4, 2013

Primary Completion Date

July 12, 2016

Completion Date

July 12, 2016

Last Updated

December 13, 2024

Enrollment

107

ACTUAL participants

Conditions

HypogonadismObesity

Interventions

Placebo

DRUG

Metformin

DRUG

Testosterone Undecanoate

DRUG

Metformin + Testosterone Undecanoate

DRUG

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 13, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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