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)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |