Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Gonadotropin Replacement Therapy in Patients With Hypogonadism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02042638
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : January 23, 2014
Sponsor:
Information provided by (Responsible Party):
Aydogan Aydogdu, Gulhane School of Medicine

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Effects of hCG replacement therapy on metabolic syndrome parameters in hypogonadotrophic hypogonadism.

Condition or disease Intervention/treatment
Idiopathic Hypogonadotropic Hypogonadism Drug: hCG 1500 IU three times a week Drug: Pregnyl (hCG) ampule 1500 IU/three times a week

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 16 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Study Start Date : January 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort 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 Name: Pregnyl (Organon) ampule 1500 IU

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. HDL after hCG treatment [ Time Frame: 2011-2013 ]
    2011-2013

  2. LDL levels after hCG treatment [ Time Frame: 2011-2013 ]
  3. total cholesterole levels after hCG treatment [ Time Frame: 2011-2013 ]

Secondary Outcome Measures :
  1. Body fat ratio after hCG treatment [ Time Frame: 2011-2013 ]
  2. hsCRP levels after hCG treatment [ Time Frame: 2011-2013 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Idiopathic Hypogonadotropic Hypogonadism
Criteria

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02042638


Locations
Layout table for location information
Turkey
Gulhane School of Medicine Dep. of Endocrinology and Metabolism
Ankara, Turkey, 06018
Sponsors and Collaborators
Gulhane School of Medicine
Investigators
Layout table for investigator information
Study Director: Fahri Bayram, Proffesor Erciyes University School of Medicine Depatment of Endocrinology and Metabolism Kayseri TURKEY
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Aydogan Aydogdu, MD, Gulhane School of Medicine
ClinicalTrials.gov Identifier: NCT02042638    
Other Study ID Numbers: 27122013
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: January 23, 2014
Last Verified: December 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
 Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs