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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01533129

Enrollment

106

Registered

2012-02-15

Start date

2008-08-31

Completion date

Unknown

Last updated

2020-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadotrophic Hypogonadism

Keywords

Hypogonadism, Endothelial dysfunction, Inflammation, Insulin resistance, Testosterone replacement therapy

Brief summary

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.

Interventions

DRUGTestogel 50 mg transdermal gel

50mg testosterone gel implementation on every night

DRUGTestosterone 250mg injection

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 26 Years

Healthy volunteers

Inclusion criteria

* Men * Treatment naive * Hypogonadotrophic hypogonadism

Exclusion criteria

* Previous history of androgen replacement * Chronic metabolic disorders

Design outcomes

Primary

Measure	Time frame	Description
The alterations in the measures for endothelial functions	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.
The alterations in the measures of insulin resistance	6 months	The alterations in insulin sensitivity are estimated by using the HOMA index by the formula, HOMA-IR = (insulin x glucose)/405.
The alterations in the measures of inflammation	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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026