This trial is active, not recruiting.

Conditions hypogonadism, obesity
Treatments placebo, metformin, testosterone undecanoate, metformin + testosterone undecanoate
Phase phase 3
Sponsor Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Start date July 2013
End date September 2016
Trial size 107 participants
Trial identifier NCT02514629, CMCS240281


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
(Placebo Comparator)
Placebo for 52 weeks
Metformin 850 mg tablets twice daily for 52 weeks
metformin Glucophage
Testosterone Undecanoate 1000 mg/4ml im injection each 12 weeks for 52 weeks
testosterone undecanoate Nebido
Metformin 850 mg tablets twice daily + Testosterone Undecanoate 1000 mg/4ml im injection each 12 weeks for 52 weeks
metformin + testosterone undecanoate

Primary Outcomes

Change in Insulin Resistance
time frame: Basal-52 weeks

Secondary Outcomes

Change in Body Weight
time frame: Basal-52 weeks
Change in Erectile Dysfunction
time frame: Basal-52 weeks
Change in the Aging Male Symptom (AMS) Scale
time frame: Basal-52 weeks
Change in the Androgen Deficiency in the Aging Male (ADAM) Questionnaire
time frame: Basal-52 weeks
Change in Testosterone Levels (Total and Free)
time frame: Basal-52 weeks
Change in Body Composition (Fat and Lean Mass)
time frame: Basal-52 weeks
Change in Biochemical Markers of Bone Turnover
time frame: Basal-52 weeks
Change in Metabolic Hormones
time frame: Basal-52 weeks

Eligibility Criteria

Male participants from 18 years up to 50 years old.

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. - 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. - Hematocrit> 50% in the screening. - PSA> 4 ng / ml. - Severe benign prostatic hypertrophy with an IPSS scale score over 19. - Evidence of drug or alcohol abuse (> 50 g alcohol / day) - Hematological diseases that produce increased risk of bleeding after intramuscular injection. - Serious underlying disease that might affect the patient's ability to participate in the study (eg ongoing infection, gastric ulcers, active autoimmune disease). - Reduced life expectancy (<12 months) by the presence of comorbidities or advanced terminals. - Participation in another clinical trial within 30 days before study entry. - Previous diagnosis of hemochromatosis - Treatment with phosphodiesterase-5 inhibitors: sildenafil, tadalafil or vardenafil

Additional Information

Official title 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
Principal investigator Jose Carlos Fernandez-Garcia, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud.