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Completed

NCT Number: NCT01533129

The Effect of Testosterone Replacement on Endothelial Dysfunction, Inflammation and Insulin Resistance in Male Hypogonadotrophic Hypogonadism

The study searched for answers to two questions

1. What is the effect of testosterone replacement therapy on endothelial dysfunction, inflammation and insulin resistance? 2. Regarding the above parameters, is there any difference between daily transdermal testosterone implementation and intramuscular injection performed in three weeks.

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Key information

Conditions

Hypogonadotrophic Hypogonadism Endocrine System Diseases Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Hypogonadism Inflammation Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–26 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Gulhane School of Medicine Department of Endocrinology and Metabolism

Ankara, Non US, 06018, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men
  • Treatment naive
  • Hypogonadotrophic hypogonadism

Exclusion criteria

  • Previous history of androgen replacement
  • Chronic metabolic disorders

Treatment and study plan

Testogel 50 mg transdermal gel

Drug

50mg testosterone gel implementation on every night

Other names: Testogel 50mg transdermal gel

Testosterone 250mg injection

Drug

The testosterone 250mg ester IM injections performed in three weeks.

Other names: Sustanon 250 mg amp.

Primary outcomes

  1. The alterations in the measures for endothelial functions

    Time frame: 6 months

    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.

  2. The alterations in the measures of insulin resistance

    Time frame: 6 months

    The alterations in insulin sensitivity are estimated by using the HOMA index by the formula, HOMA-IR = (insulin x glucose)/405.

  3. The alterations in the measures of inflammation

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Gulhane School of Medicine

Other

Registry information

Official study title

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.

Important dates

Study start
2008
Primary completion
2011
First posted
Feb 15, 2012
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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