drugset / Trial / NCT01403532

Sequential Therapy for Hypogonadotropic Hypogonadism

NCT01403532

Phase 4 Completed 100 enrolled Shanghai Jiao Tong University School of Medicine
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2009-09
Primary completion
2012-12
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gonal-f Protein / enzyme biologic 75 iu Intramuscular
Subject Zinc gluconate Small molecule 20 mg Oral
Comparator human chorionic gonadotropin Protein / enzyme biologic 2000 iu Intramuscular

Indications