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

NCT ID: NCT01454011

Last Updated: 2011-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-02-28

Brief Summary

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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

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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.

Conditions

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Secondary Hypogonadism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Testosterone 250mg injection,

Group Type ACTIVE_COMPARATOR

Testosteron 250mg injection

Intervention Type DRUG

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.

Testosterone transdermal application

Group Type ACTIVE_COMPARATOR

Testosterone 50mg transdermal application

Intervention Type DRUG

Application of testosterone 50mg transdermal gel in every night

Interventions

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Testosteron 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.

Intervention Type DRUG

Testosterone 50mg transdermal application

Application of testosterone 50mg transdermal gel in every night

Intervention Type DRUG

Other Intervention Names

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Sustanon 250 mg ampule Testogel 50mg transdermal gel

Eligibility Criteria

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Inclusion Criteria

* Congenital hypogonadotrophic hypogonadism,
* Male sex

Exclusion Criteria

* Previous history of androgen replacement,
* any chronic disorder
Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gulhane School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Alper Sonmez

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gulhane School of Medicine

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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GSM-012011

Identifier Type: -

Identifier Source: org_study_id