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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00696748
Recruitment Status : Unknown
Verified June 2008 by Russian Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : June 13, 2008
Last Update Posted : June 13, 2008
Information provided by:
Russian Academy of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Hypogonadism Drug: Nebido (testosterone undecanoate) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study With Open-Label Follow-up to Investigate the Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men
Study Start Date : October 2005
Estimated Primary Completion Date : January 2009
Estimated Study Completion Date : December 2010

Arm Intervention/treatment
Active Comparator: 1
Men receiving Nebido
Drug: Nebido (testosterone undecanoate)
Nebido (testosterone undecanoate) intramuscular 4 ml by scheme

Placebo Comparator: 2
Men receiving Placebo
Drug: Placebo
Placebo 4 mL intramuscular

Primary Outcome Measures :
  1. waist-to-hip ratio [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00696748

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Contact: Svetlana Kalinchenko, PhD +70951244301
Contact: Yuliya Tishova +79032213276

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Russian Federation
Scientific Centre for Endocrinology RAMS Recruiting
Moscow, Russian Federation, 117136
Contact: Svetlana Kalinchenko, PhD    +7(095)1244301   
Contact: Yuliya Tishova, PhDstudent    +79032213276   
Sub-Investigator: Tishova Yulya, PhD student         
Sponsors and Collaborators
Russian Academy of Medical Sciences
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Principal Investigator: Svetlana Kalinchenko, PhD Scientific Center for Endocrinology, Russia
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Svetlana Kalinchenko, Russian Research Center for Endocrinology Identifier: NCT00696748    
Other Study ID Numbers: U00006KO
First Posted: June 13, 2008    Key Record Dates
Last Update Posted: June 13, 2008
Last Verified: June 2008
Keywords provided by Russian Academy of Medical Sciences:
metabolic syndrome
testosterone undecanoate
Additional relevant MeSH terms:
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Metabolic Syndrome
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Gonadal Disorders
Endocrine System Diseases
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents