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CompletedNCT01160341Updated Jul 12, 2010

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

A Phase 4 interventional study of Testosteron in Hypogonadism, sponsored by Gulhane School of Medicine. Completed at 1 site in Turkey. Open to male participants aged 18 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-07-12.

Sponsored by Gulhane School of Medicine · Phase 4, Interventional, and Screening

Phase
Phase 4
Study type
Interventional
Enrollment
312
Allocation
Not applicable
Ages
18 Years to 26 Years
Sex
Male
01

Study 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 ?
Read the detailed description

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

02

Conditions studied

  • Hypogonadism

Keywords

  • Metabolic syndrome
  • Hypogonadism
  • Testosterone
03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's enrollment of 312 is above the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

Gulhane School of Medicine is the lead sponsor of 66 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 26 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Men
  • Congenital hypogonadism
  • Treatment Naive

Exclusion criteria

Exclusion Criteria:

  • Previous history of androgen replacement
  • Hypertension
  • Diabetes mellitus
05

Study design

Phase
Phase 4
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
312 participants (actual)

Study arms

  • Experimental
    Testosteron, secondary hypogonadism

    Drug: Testosteron

Interventions

  • DrugTestosteron

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

    Also known as: Sustanon 250mg

06

Study locations

1 site
  • Gulhane School of Medicine
    Ankara, 06018, Turkey
07

References and documents

Publications

  • 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. doi: 10.1111/j.1742-1241.2006.00992.x. PubMed 16846397 ↗
  • 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. doi: 10.1210/jc.2003-031719. PubMed 15579737 ↗
  • 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. doi: 10.2164/jandrol.107.002774. Epub 2007 Oct 3. PubMed 17916569 ↗
  • Koesling D, Schultz G, Bohme E. Sequence homologies between guanylyl cyclases and structural analogies to other signal-transducing proteins. FEBS Lett. 1991 Mar 25;280(2):301-6. doi: 10.1016/0014-5793(91)80317-v. PubMed 1672855 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01160341
Lead sponsor
Gulhane School of Medicine
First posted
Jul 12, 2010
Start date
Aug 2009
Primary completion
Jan 2010
Completion
Jan 2010
Last update
Jul 12, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

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