The Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men (NePlaM3)

Russian Academy of Medical Sciences (RAMS)

Status and phase

Unknown

Phase 3

Conditions

Hypogonadism

Metabolic Syndrome

Treatments

Drug: Nebido (testosterone undecanoate)

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00696748

U00006KO

Details and patient eligibility

About

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.

Enrollment

250 estimated patients

Sex

Male

Ages

35 to 70 years old

Volunteers

No Healthy Volunteers

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