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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 because the information has not been verified recently.
Verified June 2008 by Russian Academy of Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00696748
First received: June 11, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • waist-to-hip ratio [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00696748

Contacts
Contact: Svetlana Kalinchenko, PhD +70951244301 kalinchenko@list.ru
Contact: Yuliya Tishova +79032213276 yulya_tishova@mail.ru

Locations
Russian Federation
Scientific Centre for Endocrinology RAMS Recruiting
Moscow, Russian Federation, 117136
Contact: Svetlana Kalinchenko, PhD     +7(095)1244301     kalinchenko@list.ru    
Contact: Yuliya Tishova, PhDstudent     +79032213276     yulya_tishova@mail.ru    
Sub-Investigator: Tishova Yulya, PhD student            
Sponsors and Collaborators
Russian Academy of Medical Sciences
Investigators
Principal Investigator: Svetlana Kalinchenko, PhD Scientific Center for Endocrinology, Russia
  More Information

No publications provided by Russian Academy of Medical Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Svetlana Kalinchenko, Russian Research Center for Endocrinology
ClinicalTrials.gov Identifier: NCT00696748     History of Changes
Other Study ID Numbers: U00006KO
Study First Received: June 11, 2008
Last Updated: June 11, 2008
Health Authority: Russia: Pharmacological Committee, Ministry of Health

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

Additional relevant MeSH terms:
Hypogonadism
Metabolic Syndrome X
Gonadal Disorders
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
 Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on June 18, 2013