HypogonadismPhase 3NCT02514629
Testosterone, Metformin, or Both, for Hypogonadism in Obese Males
A Phase 3 study testing Metformin, Testosterone Undecanoate and Metformin + Testosterone Undecanoate in people with Hypogonadism and Obesity, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Hypogonadism, Obesity
- What is being tested?
- Metformin, Testosterone Undecanoate and Metformin + Testosterone Undecanoate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 1 siteSpain
- Study dates
- 4 Jul 2013to 12 Jul 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Placebo, Metformin, Testosterone Undecanoate, Metformin + Testosterone Undecanoate
- Keywords
- Hypogonadism, Obesity, Erectile Dysfunction, Testosterone, Metformin, Weight Loss, Insulin Resistance
- Medical subject headings
- Hypogonadism, Obesity, Erectile Dysfunction, Weight Loss, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
MetforminDrug
Also called Glucophage, Dianben
Testosterone UndecanoateDrug
Also called Nebido, Reandron
Metformin + Testosterone UndecanoateDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo for 52 weeks Receives: Drug: Placebo |
| Metformin | Experimental | Metformin 850 mg tablets twice daily for 52 weeks Receives: Drug: Metformin |
| Testosterone | Experimental | Testosterone Undecanoate 1000 mg/4ml im injection each 12 weeks for 52 weeks Receives: 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 Receives: Drug: Metformin + Testosterone Undecanoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Basal-52 weeks
Secondary outcomes (8)
Change in Body Weight
Body weight will be measured on a Tanita Multi-Frequency Body Composition Analyzer MC-180MA (Tanita Corporation, Tokyo, Japan) to assess change in body weight over the 52-week intervention period.
Measured: Basal-52 weeks
Change in Erectile Dysfunction
Changes in Erectile Dysfunction will be evaluated with the International Index of Erectile Function (IIEF-5) questionnaire
Measured: Basal-52 weeks
Change in the Aging Male Symptom (AMS) Scale
Change from baseline on the total score of the AMS rating scale
Measured: Basal-52 weeks
Change in the Androgen Deficiency in the Aging Male (ADAM) Questionnaire
Change from baseline on the ADAM Questionnaire
Measured: Basal-52 weeks
Change in Testosterone Levels (Total and Free)
The change from baseline to week 52 in free testosterone and total testosterone levels will be assessed
Measured: Basal-52 weeks
Change in Body Composition (Fat and Lean Mass)
Body Composition will be measured on a Tanita Multi-Frequency Body Composition Analyzer MC-180MA (Tanita Corporation, Tokyo, Japan) to assess changes in body composition (fat mass, lean mass, total body water) over the 52-week intervention period.
Measured: Basal-52 weeks
Change in Biochemical Markers of Bone Turnover
Change in Bone turnover, measured by serum procollagen type I N-terminal propeptide (PINP) and Beta-CrossLaps (β-CTx)
Measured: Basal-52 weeks
Change in Metabolic Hormones
Changes in Leptin, adiponectin, betatrophin and kisspeptin levels
Measured: Basal-52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study start4 Jul 2013
- Primary completion12 Jul 2016
- Study completion12 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Carlos Fernandez-Garcia, MD, Principal investigator, Hospital Universitario Virgen de la Victoria. Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514629
- Sponsor's protocol ID
- CMCS240281
- Status last verified
- Dec 2024
- First submitted
- 15 Jul 2015
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02514629
- Acronym / sponsor ID
- CMCS240281
- Conditions
- Hypogonadism, Obesity
- Keywords
- Hypogonadism, Obesity, Erectile Dysfunction, Testosterone, Metformin, Weight Loss, Insulin Resistance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 4 Jul 2013 (actual)
- Primary completion
- 12 Jul 2016 (actual)
- Study completion
- 12 Jul 2016 (actual)
- First posted
- 4 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for 52 weeks |
| Metformin | Experimental | Drug: MetforminMetformin 850 mg tablets twice daily for 52 weeks |
| Testosterone | Experimental | Drug: Testosterone UndecanoateTestosterone Undecanoate 1000 mg/4ml im injection each 12 weeks for 52 weeks |
| Metformin + Testosterone | Experimental | Drug: Metformin + Testosterone UndecanoateMetformin 850 mg tablets twice daily + Testosterone Undecanoate 1000 mg/4ml im injection each 12 weeks for 52 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo | Drug | Placebo |
| MetforminAlso: Glucophage, Dianben | Drug | Metformin |
| Testosterone UndecanoateAlso: Nebido, Reandron | Drug | Testosterone |
| Metformin + Testosterone Undecanoate | Drug | Metformin + Testosterone |
Primary outcome
Change in Insulin Resistance
Time frame: Basal-52 weeks
Insulin resistance will be measured using Homeostasis Model of Assessment for Insulin Resistance index (HOMA-IR index) HOMA-IR=FINS*FGLU/22.5
8 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Carlos Fernandez-Garcia, MD principal investigator
Hospital Universitario Virgen de la Victoria. Malaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metformin, Testosterone Undecanoate and Metformin + Testosterone Undecanoate in people with Hypogonadism and Obesity, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insulin Resistance (time frame: Basal-52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.