The Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men
NCT ID: NCT00696748
Last Updated: 2008-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
250 participants
INTERVENTIONAL
2005-10-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
Men receiving Nebido
Nebido (testosterone undecanoate)
Nebido (testosterone undecanoate) intramuscular 4 ml by scheme
2
Men receiving Placebo
Placebo
Placebo 4 mL intramuscular
Interventions
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Nebido (testosterone undecanoate)
Nebido (testosterone undecanoate) intramuscular 4 ml by scheme
Placebo
Placebo 4 mL intramuscular
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
35 Years
70 Years
MALE
No
Sponsors
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Russian Academy of Medical Sciences
OTHER
Responsible Party
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Russian Research Center for Endocrinology
Principal Investigators
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Svetlana Kalinchenko, PhD
Role: PRINCIPAL_INVESTIGATOR
Scientific Center for Endocrinology, Russia
Locations
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Scientific Centre for Endocrinology RAMS
Moscow, , Russia
Countries
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Central Contacts
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Facility Contacts
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Svetlana Kalinchenko, PhD
Role: primary
Yuliya Tishova, PhDstudent
Role: backup
References
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Lee H, Hwang EC, Oh CK, Lee S, Yu HS, Lim JS, Kim HW, Walsh T, Kim MH, Jung JH, Dahm P. Testosterone replacement in men with sexual dysfunction. Cochrane Database Syst Rev. 2024 Jan 15;1(1):CD013071. doi: 10.1002/14651858.CD013071.pub2.
Kalinchenko SY, Tishova YA, Mskhalaya GJ, Gooren LJ, Giltay EJ, Saad F. Effects of testosterone supplementation on markers of the metabolic syndrome and inflammation in hypogonadal men with the metabolic syndrome: the double-blinded placebo-controlled Moscow study. Clin Endocrinol (Oxf). 2010 Nov;73(5):602-12. doi: 10.1111/j.1365-2265.2010.03845.x.
Giltay EJ, Tishova YA, Mskhalaya GJ, Gooren LJ, Saad F, Kalinchenko SY. Effects of testosterone supplementation on depressive symptoms and sexual dysfunction in hypogonadal men with the metabolic syndrome. J Sex Med. 2010 Jul;7(7):2572-82. doi: 10.1111/j.1743-6109.2010.01859.x. Epub 2010 May 26.
Other Identifiers
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U00006KO
Identifier Type: -
Identifier Source: org_study_id