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The Effects of Gonadotropin Replacement Therapy in Patients With Hypogonadism

Sponsor
Gulhane School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT02042638
Collaborator
(none)
16
Enrollment
1
Location
31
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Effects of hCG replacement therapy on metabolic syndrome parameters in hypogonadotrophic hypogonadism.

Condition or Disease Intervention/Treatment Phase
  • Drug: hCG 1500 IU three times a week
  • Drug: Pregnyl (hCG) ampule 1500 IU/three times a week

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
16 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Aug 1, 2013
Actual Study Completion Date :
Aug 1, 2013

Arms and Interventions

Arm Intervention/Treatment
16 treatment naive Hypogonadotropic hypogonadism patients

Treatment naive 16 patients with idiopathic hypogonadotrophic hypogonadism

Drug: hCG 1500 IU three times a week
Other Names:
  • Pregnyl (Organon) ampule 1500 IU

    • Drug: Pregnyl (hCG) ampule 1500 IU/three times a week

    Outcome Measures

    Primary Outcome Measures

    1. HDL after hCG treatment [2011-2013]

      2011-2013

    2. LDL levels after hCG treatment [2011-2013]

    3. total cholesterole levels after hCG treatment [2011-2013]

    Secondary Outcome Measures

    1. Body fat ratio after hCG treatment [2011-2013]

    2. hsCRP levels after hCG treatment [2011-2013]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No

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

    Exclusion Criteria: Previous androgen treatment, diabetes mellitus, arterial hypertension other hormone deficiencies

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gulhane School of Medicine Dep. of Endocrinology and Metabolism Ankara Turkey 06018

    Sponsors and Collaborators

    • Gulhane School of Medicine

    Investigators

    • Study Director: Fahri Bayram, Proffesor, Erciyes University School of Medicine Depatment of Endocrinology and Metabolism Kayseri TURKEY

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aydogan Aydogdu, MD, Gulhane School of Medicine
    ClinicalTrials.gov Identifier:
    NCT02042638
    Other Study ID Numbers:
    • 27122013
    First Posted:
    Jan 23, 2014
    Last Update Posted:
    Jan 23, 2014
    Last Verified:
    Dec 1, 2013
    Additional relevant MeSH terms:
    Hypogonadism
    Chorionic Gonadotropin

    Study Results

    No Results Posted as of Jan 23, 2014