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

Idiopathic Hypogonadotropic Hypogonadism Clinical Trial

Official title:

Lipid Profile and Oxidative Stress Parameters of Patients With Idiopathic Hypogonadotropic Hypogonadism and the Change of These Parameters With Gonadotropin Replacement Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02728440
• Other study ID #: FB03232016
• Status: Completed
• Phase: N/A
• First received: March 27, 2016
• Last updated: April 11, 2016
• Start date: May 2010
• Est. completion date: December 2012

Study information

• Verified date: March 2016
• Source: Gulhane School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 22 Years to 35 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypogonadism
• Idiopathic Hypogonadotropic Hypogonadism

Intervention

Drug:
• human chorionic gonadotropin, human menopausal gonadotropin
drug for the treatment of male hypogonadism

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oxidative stress after hCG and HMG treatment		2010-2012	No
Primary	HDL levels after hCG treatment		2010-2012	No
Primary	total cholesterole levels after hCG treatment		2010-2012	No