Hypogonadism, Metabolic Syndrome
Conditions
Keywords
metabolic syndrome, hypogonadism, testosterone undecanoate
Brief summary
The objective of the study is to assess the effect of the testosterone therapy on the body composition, lipid and glucose metabolism, inflammatory markers in patients with metabolic syndrome and hypogonadism.
Interventions
Nebido (testosterone undecanoate) intramuscular 4 ml by scheme
DRUGPlacebo
Placebo 4 mL intramuscular
Sponsors
Russian Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
35 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* A signed informed consent to participate in the study * Men aged 35 to 70 with testosterone levels below 12 nmol/L or free testosterone below 225 pmol/L * Presence of the metabolic syndrome according to the IDF definition
Exclusion criteria
* Patients under 35 or above 70 years. * Participation in any clinical study within 30 days before the first injection of the drug * Simultaneous participation in another clinical study * Incapable subjects as well as prisoners * Suspicion of a serious organic or mental disease according to medical history and/or clinical examination * Prostate cancer, breast cancer or suspicion thereof * Presence or history of hepatic tumors * Acute or chronic hepatic disease * Presence of renal diseases with renal failure * Changes in biochemical or hematological laboratory values in spite of lack of clinical manifestations, in the investigator's opinion * Suspected lack of the patient's compliance * Hypersensitivity to the active substance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| waist-to-hip ratio | 3 years |
Countries
Russia
Contacts
Primary ContactSvetlana Kalinchenko, PhD
Backup ContactYuliya Tishova
Outcome results
None listed