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

June 11, 2008
June 11, 2008
October 2005
January 2009   (final data collection date for primary outcome measure)
waist-to-hip ratio [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Metabolic Syndrome
  • Hypogonadism
  • Drug: Nebido (testosterone undecanoate)
    Nebido (testosterone undecanoate) intramuscular 4 ml by scheme
  • Drug: Placebo
    Placebo 4 mL intramuscular
  • Active Comparator: 1
    Men receiving Nebido
    Intervention: Drug: Nebido (testosterone undecanoate)
  • Placebo Comparator: 2
    Men receiving Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
December 2010
January 2009   (final data collection date for primary outcome measure)

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
Male
35 Years to 70 Years
No
Contact: Svetlana Kalinchenko, PhD +70951244301 kalinchenko@list.ru
Contact: Yuliya Tishova +79032213276 yulya_tishova@mail.ru
Russian Federation
 
NCT00696748
U00006KO
No
Svetlana Kalinchenko, Russian Research Center for Endocrinology
Russian Academy of Medical Sciences
Not Provided
Principal Investigator: Svetlana Kalinchenko, PhD Scientific Center for Endocrinology, Russia
Russian Academy of Medical Sciences
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP