The Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men - Full Text View

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

This study is currently recruiting participants.

Verified by Russian Academy of Medical Sciences, June 2008

First Received: June 11, 2008 No Changes Posted

Sponsor:	Russian Academy of Medical Sciences
Information provided by:	Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00696748

Purpose

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

Resource links provided by NLM:

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Further study details as provided by Russian Academy of Medical Sciences:

Primary Outcome Measures:

waist-to-hip ratio [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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
2: Placebo Comparator Men receiving Placebo	Drug: Placebo Placebo 4 mL intramuscular

Eligibility

Ages Eligible for Study:	35 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696748

Contacts

Contact: Svetlana Kalinchenko, PhD	+70951244301	kalinchenko@list.ru
Contact: Yuliya Tishova	+79032213276	yulya_tishova@mail.ru

Locations

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

Sponsors and Collaborators

Russian Academy of Medical Sciences

Investigators

Principal Investigator:

Svetlana Kalinchenko, PhD

Scientific Center for Endocrinology, Russia

More Information

No publications provided

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 History of Changes
Health Authority:	Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Russian Academy of Medical Sciences:

metabolic syndrome
hypogonadism
testosterone undecanoate

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Methyltestosterone
Hormones

Pharmacologic Actions
Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Hypogonadism
Therapeutic Uses
Androgens

ClinicalTrials.gov processed this record on March 11, 2010