- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00696748
The Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men (NePlaM3)
June 11, 2008 updated by: Russian Academy of Medical Sciences
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
250
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Svetlana Kalinchenko, PhD
- Phone Number: +70951244301
- Email: kalinchenko@list.ru
Study Contact Backup
- Name: Yuliya Tishova
- Phone Number: +79032213276
- Email: yulya_tishova@mail.ru
Study Locations
-
-
-
Moscow, Russian Federation, 117136
- Recruiting
- Scientific Centre for Endocrinology RAMS
-
Contact:
- Svetlana Kalinchenko, PhD
- Phone Number: +7(095)1244301
- Email: kalinchenko@list.ru
-
Contact:
- Yuliya Tishova, PhDstudent
- Phone Number: +79032213276
- Email: yulya_tishova@mail.ru
-
Sub-Investigator:
- Tishova Yulya, PhD student
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 1
Men receiving Nebido
|
Nebido (testosterone undecanoate) intramuscular 4 ml by scheme
|
PLACEBO_COMPARATOR: 2
Men receiving Placebo
|
Placebo 4 mL intramuscular
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
waist-to-hip ratio
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Svetlana Kalinchenko, PhD, Scientific Center for Endocrinology, Russia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (ANTICIPATED)
January 1, 2009
Study Completion (ANTICIPATED)
December 1, 2010
Study Registration Dates
First Submitted
June 11, 2008
First Submitted That Met QC Criteria
June 11, 2008
First Posted (ESTIMATE)
June 13, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
June 13, 2008
Last Update Submitted That Met QC Criteria
June 11, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Disease
- Gonadal Disorders
- Insulin Resistance
- Hyperinsulinism
- Syndrome
- Metabolic Syndrome
- Hypogonadism
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Androgens
- Anabolic Agents
- Testosterone
- Methyltestosterone
- Testosterone undecanoate
- Testosterone enanthate
- Testosterone 17 beta-cypionate
Other Study ID Numbers
- U00006KO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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