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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by Russian Academy of Medical Sciences.
Recruitment status was:  Recruiting
Information provided by:
Russian Academy of Medical Sciences Identifier:
First received: June 11, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
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 Intervention Phase
Metabolic Syndrome Hypogonadism Drug: Nebido (testosterone undecanoate) Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Russian Academy of Medical Sciences:

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

Estimated Enrollment: 250
Study Start Date: October 2005
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00696748

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

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
Principal Investigator: Svetlana Kalinchenko, PhD Scientific Center for Endocrinology, Russia
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Svetlana Kalinchenko, Russian Research Center for Endocrinology Identifier: NCT00696748     History of Changes
Other Study ID Numbers: U00006KO
Study First Received: June 11, 2008
Last Updated: June 11, 2008

Keywords provided by Russian Academy of Medical Sciences:
metabolic syndrome
testosterone undecanoate

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Gonadal Disorders
Endocrine System Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents processed this record on September 20, 2017