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Effects of Gonadotropin Replacement Therapy on Metabolic Parameters in Patients With Hypogonadism

Sponsor
Gulhane School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT02728440
Collaborator
(none)
30
Enrollment
31
Duration (Months)

Study Details

Study Description

Brief Summary

Effects of gonadotrophin replacement therapy Lipid Profile and Oxidative Stress Parameters of Patients with Idiopathic Hypogonadotropic Hypogonadism

Condition or Disease Intervention/Treatment Phase
  • Drug: human chorionic gonadotropin, human menopausal gonadotropin

Detailed Description

30 male patients diagnosed with IHH and a control group of 20 healthy cases with similar age and BMI were included in the study. The levels of advanced oxidation protein products (AOPP), thiol, malondialdehyde (MDA), nitric oxide (NO) and 8-hydroxydeoxyguanosine (8-OHdG) and the levels of triglyceride (TG), total cholesterol (TC), high density lipoprotein (HDL-K), low density lipoprotein (LDL-K), Apolipoprotein A1 (ApoA1) and Apolipoprotein B100 (ApoB100) were measured before and after gonadotrophin therapy.

Study Design

Study Type:
Observational
Actual Enrollment :
30 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Lipid Profile and Oxidative Stress Parameters of Patients With Idiopathic Hypogonadotropic Hypogonadism and the Change of These Parameters With Gonadotropin Replacement Therapy
Study Start Date :
May 1, 2010
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Hypogonadotropic hypogonadism patients

30 patients with idiopathic hypogonadotrophic hypogonadism

Drug: human chorionic gonadotropin, human menopausal gonadotropin
drug for the treatment of male hypogonadism
Other Names:
  • Pregnyl ® Organon hCG 1500 IU
  • Merional ® ARIS 75 IU

    		•

    Outcome Measures

    Primary Outcome Measures

    1. oxidative stress after hCG and HMG treatment [2010-2012]

    2. HDL levels after hCG treatment [2010-2012]

    3. total cholesterole levels after hCG treatment [2010-2012]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years to 35 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Serum testosterone concentration < 300ng/dL Absence of a pituitary or hypothalamic mass lesions, Presence of gonadotropin response to GnRH, -

    Exclusion Criteria:

    diabetes mellitus, arterial hypertension other hormone deficiencies

    -

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Gulhane School of Medicine

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aydogan Aydogdu, MD, Gulhane School of Medicine
    ClinicalTrials.gov Identifier:
    NCT02728440
    Other Study ID Numbers:
    • FB03232016
    First Posted:
    Apr 5, 2016
    Last Update Posted:
    Apr 13, 2016
    Last Verified:
    Mar 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Hypogonadism
    Chorionic Gonadotropin
    Menotropins

    Study Results

    No Results Posted as of Apr 13, 2016