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)

NCT01709331

Phase 3 Completed 18 enrolled Organon and Co
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

EvaluationDrugModalityDoseRoute
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