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Metabolic Syndrome Criteria and the Effect of Testosterone Treatment in Young Men With Hypogonadism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01160341
First Posted: July 12, 2010
Last Update Posted: July 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Gulhane School of Medicine
  Purpose

The study is designed to answer the following questions:

  1. Is hypogonadism a cause for the metabolic syndrome ?
  2. What is the effect of testosterone replacement on the metabolic parameters ?

Condition Intervention Phase
Hypogonadism Drug: Testosteron Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Phase 4 Study of About the Effect of Testosterone Treatment on the Components of Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Gulhane School of Medicine:

Enrollment: 312
Study Start Date: August 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Testosteron, secondary hypogonadism Drug: Testosteron
Testosteron 250mg injection per 3-4 weeks for 6 months
Other Name: Sustanon 250mg

Detailed Description:
This is a retrospective design, which is performed by investigating the registrations of patients with hypogonadotrophic hypogonadism between the years 2002-2009.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 26 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men
  • Congenital hypogonadism
  • Treatment Naive

Exclusion Criteria:

  • Previous history of androgen replacement
  • Hypertension
  • Diabetes mellitus
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01160341


Locations
Turkey
Gulhane School of Medicine
Ankara, Turkey, 06018
Sponsors and Collaborators
Gulhane School of Medicine
  More Information

Publications:
Responsible Party: Dr. Alper Sonmez, Gulhane School of Medicine Department of Endocrinology and Metabolism
ClinicalTrials.gov Identifier: NCT01160341     History of Changes
Other Study ID Numbers: GSM-072010
First Submitted: July 9, 2010
First Posted: July 12, 2010
Last Update Posted: July 12, 2010
Last Verified: January 2010

Keywords provided by Gulhane School of Medicine:
Metabolic syndrome
Hypogonadism
Testosterone

Additional relevant MeSH terms:
Metabolic Syndrome X
Hypogonadism
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents