Sequential Therapy for Hypogonadotropic Hypogonadism

Hypogonadotropic Hypogonadism Clinical Trial

Official title:

Efficacy and Safety of Human Chorionic Gonadotropin (HCG) and Follicle Stimulating Hormone (FSH) in the Treatment of Hypogonadotropic Hypogonadism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01403532
• Other study ID #: CCEMD005
• Status: Completed
• Phase: Phase 4
• First received: February 1, 2011
• Last updated: February 10, 2014
• Start date: September 2009
• Est. completion date: December 2012

Study information

• Verified date: February 2014
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The traditional therapy for induction of spermatogenesis in male hypogonadotropic hypogonadism requires both HCG and human menopausal gonadotropin (HMG) or FSH until pregnancy occurs. Because of the high cost of hMG or FSH preparations and poor compliance, the investigators raise a new sequential therapeutic approach which can make the treatment more economic and tolerable. The zinc supplement will be also evaluated in patients in this study. This randomized, parallel, open, and multi-center study will compare the efficacy of traditional therapy with new therapy and evaluate the safety of the new protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years to 45 Years

Eligibility

Inclusion Criteria:

• Clinical hypogonadotropic hypogonadism

• Hormonal levels: Testosterone < 1.8ng/ml, LH < 2-3 mIU/mL and FSH < 2-3 mIU/mL

• Infantile testis

• Delayed bone age

• Normal testing of the anterior pituitary gland

Exclusion Criteria:

• Prior therapy with HMG or FSH

• Severe dysfunction of live and kidney

• Cryptorchidism or no response to HCG stimulation experiment (Testosterone < 1.8ng/ml after HCG stimulation)

• Another pituitary hormonal deficiency

• Hypergonadotropic hypogonadism

• With abnormal karyotype

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism
• Hypogonadotropic Hypogonadism
• Kallmann Syndrome

Intervention

Drug:
• Traditional intervention for HH using HCG and FSH
Human chorionic gonadotropin(HCG),2000U,im,2 times/week, one year and a half; Follicle stimulating hormone(FSH),75U, im, 3 times/week, one year;
• Sequential intervention for HH using HCG and FSH
Human chorionic gonadotropin,2000U,im, 2 times/week, one and half a year Follicle stimulating hormone,75U,im,3 times/week, every other three months
• Sequential intervention for HH using HCG and FSH plus zinc
Human chorionic gonadotropin,2000U,im,2 times/week, one year and a half Follicle stimulating hormone,75U, im, 3 times/week, every other three months Zinc gluconate 20mg,P.O, twice daily

Locations

Country	Name	City	State
China	Rui Jin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sperm density =1,000,000/ml	The sperm will be counted as equal or more than 1,000,000/ml under microscope for each subject.	One and a half year	Yes