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Visceral Adiposity Index and Triglyceride/High-density Lipoprotein Cholesterol Ratio in the Congenital Hypogonadotropic Hypogonadism and Effect of Testosteron Treatment

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ClinicalTrials.gov Identifier: NCT02111434
Recruitment Status : Completed
First Posted : April 11, 2014
Last Update Posted : April 14, 2014
Sponsor:
Information provided by (Responsible Party):
cem haymana, Gulhane School of Medicine

Brief Summary:

The study is designed to answer the following questions:

  1. What is the levels of visceral adiposity index and Triglycerides/HDL cholesterol ratio in hypogonadism?
  2. What is the effect of testosterone replacement on the visceral adiposity index and Triglycerides/HDL cholesterol ratio?

Condition or disease Intervention/treatment Phase
Hypogonadism Drug: Testosterone Phase 4

Detailed Description:
This is a retrospective design, which is performed by investigating the registrations of patients with hypogonadotrophic hypogonadism between the years 2007-2010.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Phase 4 Study of Effect of Testosteron Treatment on the Visceral Adiposity Index and Triglyceride/High-density Lipoprotein Cholesterol Ratio in the Congenital Hypogonadotropic Hypogonadism
Study Start Date : July 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014


Arm Intervention/treatment
Experimental: testosterone
testosterone gel per day for 6 months testosterone 250 mg injection per 3-4 weeks for 6 months
Drug: Testosterone
Testosterone 250 mg injection per 3-4 weeks for 6 months
Other Name: sustanon 250 mg




Primary Outcome Measures :
  1. time to change of visceral adiposity index with testosteron replacement [ Time Frame: baseline and 6 months ]
  2. time to change of TG/HDL cholesterol ratio with testosteron replacement [ Time Frame: baseline and 6 months ]


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Ages Eligible for Study:   18 Years to 26 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men
  • Congenital hypogonadism
  • Treatment Naive

Exclusion Criteria:

  • Previous history of androgen replacement
  • Hypertension
  • Diabetes mellitus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111434


Locations
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Turkey
Gulhane School of Medicine
Ankara, Turkey, 06018
Sponsors and Collaborators
Gulhane School of Medicine

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Responsible Party: cem haymana, MD, Gulhane School of Medicine
ClinicalTrials.gov Identifier: NCT02111434     History of Changes
Other Study ID Numbers: GSM-022014
First Posted: April 11, 2014    Key Record Dates
Last Update Posted: April 14, 2014
Last Verified: April 2014
Keywords provided by cem haymana, Gulhane School of Medicine:
visceral adiposity index
triglycerides / hdl cholesterol ratio
testosterone
Additional relevant MeSH terms:
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Obesity
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents