The Effects of Gonadotropin Replacement Therapy in Patients With Hypogonadism

Idiopathic Hypogonadotropic Hypogonadism Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02042638
• Other study ID #: 27122013
• Status: Completed
• Phase: N/A
• First received: December 28, 2013
• Last updated: January 22, 2014
• Start date: January 2011
• Est. completion date: August 2013

Study information

• Verified date: December 2013
• Source: Gulhane School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years to 45 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: Previous androgen treatment, diabetes mellitus, arterial hypertension other hormone deficiencies

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypogonadism
• Idiopathic Hypogonadotropic Hypogonadism

Intervention

Drug:
• hCG 1500 IU three times a week

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

Locations

Country	Name	City	State
Turkey	Gulhane School of Medicine Dep. of Endocrinology and Metabolism	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane School of Medicine

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HDL after hCG treatment	2011-2013	2011-2013	Yes
Primary	LDL levels after hCG treatment		2011-2013	Yes
Primary	total cholesterole levels after hCG treatment		2011-2013	Yes
Secondary	Body fat ratio after hCG treatment		2011-2013	Yes
Secondary	hsCRP levels after hCG treatment		2011-2013	Yes