Metabolic Syndrome Criteria and the Effect of Testosterone Treatment in Young Men With Hypogonadism
Phase 4 Study of About the Effect of Testosterone Treatment on the Components of Metabolic Syndrome
1 other identifier
interventional
312
1 country
1
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 ?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2009
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 9, 2010
CompletedFirst Posted
Study publicly available on registry
July 12, 2010
CompletedJuly 12, 2010
January 1, 2010
5 months
July 9, 2010
July 9, 2010
Conditions
Keywords
Study Arms (1)
Testosteron, secondary hypogonadism
EXPERIMENTALInterventions
Testosteron 250mg injection per 3-4 weeks for 6 months
Eligibility Criteria
You may qualify if:
- Men
- Congenital hypogonadism
- Treatment Naive
You may not qualify if:
- Previous history of androgen replacement
- Hypertension
- Diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gulhane School of Medicine
Ankara, 06018, Turkey (Türkiye)
Related Publications (4)
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.
PMID: 16846397BACKGROUNDAraujo 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.
PMID: 15579737BACKGROUNDSaad 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.
PMID: 17916569BACKGROUNDKoesling 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.
PMID: 1672855BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 9, 2010
First Posted
July 12, 2010
Study Start
August 1, 2009
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
July 12, 2010
Record last verified: 2010-01