drugset / Trial / NCT01709331
A Study of the Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adult Men With Hypogonadotropic Hypogonadism (HH) (P07937)
NaSingle-groupOpen-labelTreatment
Summary
This study will assess if corifollitropin alfa (MK-8962), when administered in combination with human chorionic gonadotropin (hCG), will increase testicular volume in men with HH who remain azoospermic after treatment with hCG alone. Hypothesis: The lower limit of the 95% confidence interval for the geometric mean increase in testicular volume from Day 1 to Week 52 is greater than one.
Timeline
- Start
- 2013-02-11
- Primary completion
- 2015-04-08
- Completion
- 2015-04-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Corifollitropin alfa | Protein / enzyme biologic | 150 ug | Subcutaneous |
| Background | human chorionic gonadotropin | Protein / enzyme biologic | 1500 iu | Subcutaneous |
| Background | human chorionic gonadotropin | Protein / enzyme biologic | 3000 iu | Subcutaneous |