Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

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

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. Identifier: NCT01160341
Recruitment Status : Completed
First Posted : July 12, 2010
Last Update Posted : July 12, 2010
Information provided by:
Gulhane School of Medicine

Brief Summary:

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 or disease Intervention/treatment Phase
Hypogonadism Drug: Testosteron Phase 4

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 312 participants
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
Study Start Date : August 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Arm Intervention/treatment
Experimental: Testosteron, secondary hypogonadism Drug: Testosteron
Testosteron 250mg injection per 3-4 weeks for 6 months
Other Name: Sustanon 250mg

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 26 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Men
  • Congenital hypogonadism
  • Treatment Naive

Exclusion Criteria:

  • Previous history of androgen replacement
  • Hypertension
  • Diabetes mellitus

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 identifier (NCT number): NCT01160341

Layout table for location information
Gulhane School of Medicine
Ankara, Turkey, 06018
Sponsors and Collaborators
Gulhane School of Medicine

Layout table for additonal information
Responsible Party: Dr. Alper Sonmez, Gulhane School of Medicine Department of Endocrinology and Metabolism Identifier: NCT01160341    
Other Study ID Numbers: GSM-072010
First Posted: July 12, 2010    Key Record Dates
Last Update Posted: July 12, 2010
Last Verified: January 2010
Keywords provided by Gulhane School of Medicine:
Metabolic syndrome
Additional relevant MeSH terms:
Layout table for MeSH terms
Metabolic Syndrome
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Gonadal Disorders
Endocrine System Diseases
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents