The Effect of Testosterone Replacement on the High Density Lipoprotein Cholesterol Subgroups

Phase 4 Study That Compares the High Density Lipoprotein Cholesterol (HDL) Cholesterol Subgroups of the Patients With Congenital Hypogonadotrophic Hypogonadism With That of the Healthy Control Subjects, and Investigates the Effect of Testosterone Treatment on HDL Subgroups.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01454011

Enrollment

140

Registered

2011-10-18

Start date

2008-09-30

Completion date

2011-02-28

Last updated

2011-10-18

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

Conditions

Secondary Hypogonadism

Keywords

hypogonadism, testosterone, HDL cholesterol subgroups, hsCRP, HOMA-IR

Brief summary

The study is designed to answer the following questions: 1. Is there any difference between the compositions of the HDL cholesterol subpopulations of patients with hypogonadism and the healthy controls. 2. What is the effect of testosterone replacement therapy on the distributions of HDL subgroups. 3. Is there any difference between the effects of the two different testosteron replacement regiments

Detailed description

This study has two designs: 1. The case control design to search for the difference between the HDL subgroups and the other metabolic parameters between the healthy subjects and the patients with hypogonadism 2. The follow-up study to search for the effects of two different testosterone replacement regiments.

Interventions

DRUGTestosteron 250mg injection

The combination of 4 different testosterone esthers (30 mg testosterone propionate, 60 mg testosterone phenylpropionate, 60 mg testosterone isocaproate and 100 mg testosterone decanoate) injected in 3 weeks intervals.

DRUGTestosterone 50mg transdermal application

Application of testosterone 50mg transdermal gel in every night

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Healthy volunteers

Yes

Inclusion criteria

* Congenital hypogonadotrophic hypogonadism, * Male sex

Exclusion criteria

* Previous history of androgen replacement, * any chronic disorder

Design outcomes

Primary

Measure	Time frame	Description
Changes in the HDL cholesterol levels and the HDL subgroups	6 months	The HDL subfractions were measured by polyethylene glycol (PEG) precipitation technique. Two different reagents were prepared in different PEG concentrations and pH values. The supernatant of the solution precipitated with reagent A contained total HDL cholesterol while the supernatant of the solution precipitated with reagent B, contained only the HDL3 subclass. The cholesterol was then quantified by enzymatic with CHOD-PAP reagent (Olympus Diagnostics GmbH, Hamburg, Germany). HDL2 cholesterol was measured by calculating the difference between total HDL and the HDL3 subclass.

Countries

Turkey (Türkiye)

Outcome results

None listed

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