NCT01403532

Sequential Therapy for Hypogonadotropic Hypogonadism

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: Male
• Age: 16 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypogonadotropic Hypogonadism
• Kallmann Syndrome

Interventions

Type	Name	Description
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;
DRUG	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
DRUG	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

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2011-07-27
• Last updated: 2014-02-11

Locations

1 site across 1 country: China