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

Hypogonadism Clinical Trial

Official title:

Phase 4 Study of About the Effect of Testosterone Treatment on the Components of Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01160341
• Other study ID #: GSM-072010
• Status: Completed
• Phase: Phase 4
• First received: July 9, 2010
• Last updated: July 9, 2010
• Start date: August 2009
• Est. completion date: January 2010

Study information

• Verified date: January 2010
• Source: Gulhane School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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 ?

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 26 Years

Eligibility

Inclusion Criteria:

• Men

• Congenital hypogonadism

• Treatment Naive

Exclusion Criteria:

• Previous history of androgen replacement

• Hypertension

• Diabetes mellitus

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Hypogonadism
• Metabolic Syndrome X

Intervention

Drug:
• Testosteron
Testosteron 250mg injection per 3-4 weeks for 6 months

Locations

Country	Name	City	State
Turkey	Gulhane School of Medicine	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane School of Medicine

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Araujo AB, O'Donnell AB, Brambilla DJ, Simpson WB, Longcope C, Matsumoto AM, McKinlay JB. Prevalence and incidence of androgen deficiency in middle-aged and older men: estimates from the Massachusetts Male Aging Study. J Clin Endocrinol Metab. 2004 Dec;89(12):5920-6. — View Citation

Koesling D, Schultz G, Böhme E. Sequence homologies between guanylyl cyclases and structural analogies to other signal-transducing proteins. FEBS Lett. 1991 Mar 25;280(2):301-6. Review. — View Citation

Mulligan T, Frick MF, Zuraw QC, Stemhagen A, McWhirter C. Prevalence of hypogonadism in males aged at least 45 years: the HIM study. Int J Clin Pract. 2006 Jul;60(7):762-9. — View Citation

Saad F, Gooren LJ, Haider A, Yassin A. A dose-response study of testosterone on sexual dysfunction and features of the metabolic syndrome using testosterone gel and parenteral testosterone undecanoate. J Androl. 2008 Jan-Feb;29(1):102-5. Epub 2007 Oct 3. — View Citation