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

This study has been completed.
Sponsor:
Information provided by:
Gulhane School of Medicine
ClinicalTrials.gov Identifier:
NCT01160341
First received: July 9, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  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: 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

Ages Eligible for Study:   18 Years to 26 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 9, 2010
Last Updated: July 9, 2010
Health Authority: Turkey: Ethics Committee

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

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

ClinicalTrials.gov processed this record on July 20, 2014