drugset / Trial / NCT03687606

Efficacy and Safety of Long Term Use of hCG or hCG Plus hMG in Males With Isolated Hypogonadotropic Hypogonadism (IHH)

NCT03687606

Phase 4 Unknown 210 enrolled Tongji Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate the efficacy and safety of long term use of hCG alone or hCG plus hMG in the treatment of male patients with isolated hypogonadotropic hypogonadism (IHH). One third of the participants will receive hCG treatment alone and the other third of the participants will receive hCG treatment alone for six months, then the hMG will be added. And the last third of the participants will receive hCG and hMG treatment since the beginning of the treatment.

Timeline

Start
2018-10-18
Primary completion
2024-10-01
Completion
2025-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject human chorionic gonadotropin Protein / enzyme biologic 75 iu Intramuscular
Subject human chorionic gonadotropin Protein / enzyme biologic 150 iu Intramuscular
Subject human chorionic gonadotropin Protein / enzyme biologic 2000 iu Intramuscular
Subject human chorionic gonadotropin Protein / enzyme biologic 6000 iu Intramuscular