drugset / Trial / NCT03019575

Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adolescent Males With Hypogonadotropic Hypogonadism (HH) (MK-8962-043)

NCT03019575

Phase 3 Completed 17 enrolled Organon and Co
NaSingle-groupOpen-labelTreatment

Summary

The purpose of the study is to investigate whether corifollitropin alfa (MK-8962), administered alone for 12 weeks and then in combination with human chorionic gonadotropin (hCG) for 52 weeks, increases the testicular volume in adolescent males aged 14 to \<18. In addition, the study will evaluate participants for safety, tolerability and for the development of corifollitropin alfa antibodies. No formal hypothesis will be tested for this estimation study

Timeline

Start
2017-02-02
Primary completion
2020-05-05
Completion
2020-05-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Corifollitropin alfa Protein / enzyme biologic 100 ug Subcutaneous
Subject Corifollitropin alfa Protein / enzyme biologic 150 ug Subcutaneous
Subject hCG Unknown 500 iu Subcutaneous
Subject hCG Unknown 5000 iu Subcutaneous