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

NCT02514629 | Completed Phase 3

• 1 other identifier: CMCS240281
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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

Conditions

Hypogonadism; Obesity

Keywords

Hypogonadism; Obesity; Erectile Dysfunction; Testosterone; Metformin; Weight Loss; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Change in Insulin Resistance

  Insulin resistance will be measured using Homeostasis Model of Assessment for Insulin Resistance index (HOMA-IR index) HOMA-IR=FINS\*FGLU/22.5

  Basal-52 weeks

Secondary Outcomes (8)

• Change in Body Weight

  Basal-52 weeks

• Change in Erectile Dysfunction

  Basal-52 weeks

• Change in the Aging Male Symptom (AMS) Scale

  Basal-52 weeks

• Change in the Androgen Deficiency in the Aging Male (ADAM) Questionnaire

  Basal-52 weeks

• Change in Testosterone Levels (Total and Free)

  Basal-52 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo for 52 weeks

Drug: Placebo

Metformin

EXPERIMENTAL

Metformin 850 mg tablets twice daily for 52 weeks

Drug: Metformin

Testosterone

EXPERIMENTAL

Testosterone Undecanoate 1000 mg/4ml im injection each 12 weeks for 52 weeks

Drug: Testosterone Undecanoate

Metformin + Testosterone

EXPERIMENTAL

Metformin 850 mg tablets twice daily + Testosterone Undecanoate 1000 mg/4ml im injection each 12 weeks for 52 weeks

Drug: Metformin + Testosterone Undecanoate

Interventions

Placebo DRUG

Placebo

Metformin DRUG

Also known as: Glucophage, Dianben

Metformin

Testosterone Undecanoate DRUG

Also known as: Nebido, Reandron

Testosterone

Metformin + Testosterone Undecanoate DRUG

Metformin + Testosterone

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Uncontrolled hypertension (SBP\> 160 mmHg or DBP\> 100 mmHg) despite adequate antihypertensive therapy.
• HIV infection or known active infection with HBV or HCV.
• Thrombotic or embolic disease.
• Heart disease, kidney or liver disease.
• Epilepsy or migraine not adequately controlled with treatment.

Sponsors & Collaborators

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

Study Sites (1)

Hospital Uiversitario Virgen de la Victoria

Málaga, Malaga, 29010, Spain

Location

MeSH Terms

Conditions

Hypogonadism; Obesity; Erectile Dysfunction; Weight Loss; Insulin Resistance

Interventions

Metformin; testosterone undecanoate

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Body Weight Changes; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Jose Carlos Fernandez-Garcia, MD

  Hospital Universitario Virgen de la Victoria. Malaga

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: August 4, 2015
• Study Start: July 4, 2013
• Primary Completion: July 12, 2016
• Study Completion: July 12, 2016
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

ES (1)