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


Tracking Information

Start Date  ICMJEOctober 2005
Estimated Primary Completion DateJanuary 2009   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: June 11, 2008)		waist-to-hip ratio [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryNo Changes Posted

Descriptive Information

Brief Title  ICMJEThe Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men
Official Title  ICMJEA 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
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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Metabolic Syndrome
  • Hypogonadism
Intervention  ICMJE
  • Drug: Nebido (testosterone undecanoate)
    Nebido (testosterone undecanoate) intramuscular 4 ml by scheme
  • Drug: Placebo
    Placebo 4 mL intramuscular
Study Arms / Comparison Groups
  • 1: Active Comparator
    Men receiving Nebido
    Intervention: Drug: Nebido (testosterone undecanoate)
  • 2: Placebo Comparator
    Men receiving Placebo
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE250
Estimated Completion DateDecember 2010
Estimated Primary Completion DateJanuary 2009   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderMale
Ages35 Years to 70 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Svetlana Kalinchenko, PhD+70951244301kalinchenko@list.ru
Contact: Yuliya Tishova+79032213276yulya_tishova@mail.ru
Location Countries  ICMJERussian Federation

Administrative Information