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

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

Study Contact Backup

Study Locations

      • Moscow, Russian Federation, 117136
        • Recruiting
        • Scientific Centre for Endocrinology RAMS
        • Contact:
        • Contact:
        • 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.

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

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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