The Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men (NePlaM3)
Primary Purpose
Metabolic Syndrome, Hypogonadism
Status
Unknown status
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Nebido (testosterone undecanoate)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring metabolic syndrome, hypogonadism, testosterone undecanoate
Eligibility 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
Sites / Locations
- Scientific Centre for Endocrinology RAMSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Men receiving Nebido
Men receiving Placebo
Outcomes
Primary Outcome Measures
waist-to-hip ratio
Secondary Outcome Measures
Full Information
NCT ID
NCT00696748
First Posted
June 11, 2008
Last Updated
June 11, 2008
Sponsor
Russian Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00696748
Brief Title
The Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men
Acronym
NePlaM3
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 Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2005 (undefined)
Primary Completion Date
January 2009 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Russian Academy of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Hypogonadism
Keywords
metabolic syndrome, hypogonadism, testosterone undecanoate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Men receiving Nebido
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Men receiving Placebo
Intervention Type
Drug
Intervention Name(s)
Nebido (testosterone undecanoate)
Intervention Description
Nebido (testosterone undecanoate) intramuscular 4 ml by scheme
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 4 mL intramuscular
Primary Outcome Measure Information:
Title
waist-to-hip ratio
Time Frame
3 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Svetlana Kalinchenko, PhD
Phone
+70951244301
Email
kalinchenko@list.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Yuliya Tishova
Phone
+79032213276
Email
yulya_tishova@mail.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Svetlana Kalinchenko, PhD
Organizational Affiliation
Scientific Center for Endocrinology, Russia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scientific Centre for Endocrinology RAMS
City
Moscow
ZIP/Postal Code
117136
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Svetlana Kalinchenko, PhD
Phone
+7(095)1244301
Email
kalinchenko@list.ru
First Name & Middle Initial & Last Name & Degree
Yuliya Tishova, PhDstudent
Phone
+79032213276
Email
yulya_tishova@mail.ru
First Name & Middle Initial & Last Name & Degree
Tishova Yulya, PhD student
12. IPD Sharing Statement
Citations:
PubMed Identifier
20718771
Citation
Kalinchenko SY, Tishova YA, Mskhalaya GJ, Gooren LJ, Giltay EJ, Saad F. Effects of testosterone supplementation on markers of the metabolic syndrome and inflammation in hypogonadal men with the metabolic syndrome: the double-blinded placebo-controlled Moscow study. Clin Endocrinol (Oxf). 2010 Nov;73(5):602-12. doi: 10.1111/j.1365-2265.2010.03845.x. Erratum In: Clin Endocrinol (Oxf). 2011 Aug;75(2):275.
Results Reference
derived
PubMed Identifier
20524974
Citation
Giltay EJ, Tishova YA, Mskhalaya GJ, Gooren LJ, Saad F, Kalinchenko SY. Effects of testosterone supplementation on depressive symptoms and sexual dysfunction in hypogonadal men with the metabolic syndrome. J Sex Med. 2010 Jul;7(7):2572-82. doi: 10.1111/j.1743-6109.2010.01859.x. Epub 2010 May 26.
Results Reference
derived
Learn more about this trial
The Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men
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