Phase 4 Study That Evaluates the Effects of Two Different Testosterone Replacement Regiments on Endothelial Dysfunction, Inflammation and Insulin Resistance in Male Subjects With Hypogonadotrophic Hypogonadism.
Sponsor study identifier
interventional
106
1 country
1
Study Start
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2011
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.
April 2011
Actual (reported)December 13, 2011
Actual (reported)February 15, 2012
Actual (reported)The alterations in the measures for endothelial functions
The alterations in Endothelial functions are determined by measuring plazma ADMA levels, as a surrogate. ADMA measurement is pereformed by ELISA kit (Immundiagnotik, Bensheim, Germany)(Catalog Number 7828) with a minimal detection limit of 0.05µmol/L.
6 months
The alterations in the measures of insulin resistance
The alterations in insulin sensitivity are estimated by using the HOMA index by the formula, HOMA-IR = (insulin x glucose)/405.
6 months
The alterations in the measures of inflammation
The alterations in the measures of inflammation are determined by measuring Human Pentraxin-3 levels. ELISA kiti /R\&D Systems, Inc. Minneapolis, MN, ABD) (Catalog number DPTX30) with a minimal detection limit of 0.025ng/ml, intraassay CV of 3.8-4.4%, and interassay CV of 4.1-6.1% was used.
6 months
Testosteron 250mg injection per 3-4 weeks for 6 months
50mg testosterone gel implementation on every night
The testosterone 250mg ester IM injections performed in three weeks.
Gulhane School of Medicine Department of Endocrinology and Metabolism
Ankara, Non US, 06018, Turkey (Türkiye)
106 participants (actual enrollment reported by the registry).
First Submitted
December 13, 2011
First Posted
February 15, 2012
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
April 2011
Actual (reported)Last Updated
July 22, 2020
Record last verified: 2020-07
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Source: ClinicalTrials.gov.
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