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Sponsored by: |
Russian Academy of Medical Sciences |
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Information provided by: | Russian Academy of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT00696748 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
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 |
---|---|
1: Active Comparator
Men receiving Nebido
|
Drug: Nebido (testosterone undecanoate)
Nebido (testosterone undecanoate) intramuscular 4 ml by scheme
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2: Placebo Comparator
Men receiving Placebo
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Drug: Placebo
Placebo 4 mL intramuscular
|
Ages Eligible for Study: | 35 Years to 70 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Svetlana Kalinchenko, PhD | +70951244301 | kalinchenko@list.ru |
Contact: Yuliya Tishova | +79032213276 | yulya_tishova@mail.ru |
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 |
Principal Investigator: | Svetlana Kalinchenko, PhD | Scientific Center for Endocrinology, Russia |
Responsible Party: | Russian Research Center for Endocrinology ( Svetlana Kalinchenko ) |
Study ID Numbers: | U00006KO |
Study First Received: | June 11, 2008 |
Last Updated: | June 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00696748 |
Health Authority: | Russia: Pharmacological Committee, Ministry of Health |
metabolic syndrome hypogonadism testosterone undecanoate |
Testosterone Hypogonadism Gonadal Disorders Endocrine System Diseases |
Methyltestosterone Endocrinopathy Testosterone 17 beta-cypionate |
Anabolic Agents Pathologic Processes Disease Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses |
Syndrome Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions Androgens |