Phase 4 Study That Evaluates the Presence of Endothelial Dysfunction, Inflammation and Insulin Resistance in Male Subjects With Hypogonadotrophic Hypogonadism and Effects of Two Different Testosterone Replacement Regiments on These Parameters.
Sponsor study identifier
interventional
130
1 country
1
Study Start
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2012
Actual (reported)Study Completion
Not reported
Date not reportedThe study searched for answers to two questions
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
June 2012
Actual (reported)June 20, 2014
Actual (reported)June 24, 2014
Actual (reported)The alterations in the measures for endothelial functions
The alterations in Endothelial functions are determined by measuring plasma asymmetric dimethylarginine (ADMA) levels, as a surrogate. ADMA measurement is performed by ELISA kit (Immunodiagnostic, Bernheim, Germany)(Catalog Number 7828) with a minimal detection limit of 0.05µmol/L.
6 months
The alterations in the measures of inflammation
The alterations in the measures of inflammation are determined by measuring plasma TWEAK levels. ELISA kit (Bender MedSystems, Lot Nr.BMS2006INST, Vienna, Austria) was used.
6 months
The alterations in the measures of insulin resistance
The alterations in insulin sensitivity are estimated by using the homeostasis model assessment (HOMA) index by the formula, HOMA = (insulin x glucose)/405.
6 months.
Testosteron 250mg injection per 3-4 weeks for 6 months
The testosterone 250mg ester intramuscular injections performed in three weeks
50mg testosterone gel implemented on every night
Gulhane School of Medicine Department of Endocrinology and Metabolism
Ankara, NonUS, 06018, Turkey (Türkiye)
130 participants (actual enrollment reported by the registry).
First Submitted
June 20, 2014
First Posted
June 24, 2014
Study Start
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 2012
Actual (reported)Last Updated
June 24, 2014
Record last verified: 2014-03
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Source: ClinicalTrials.gov.
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