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)

A Phase III, Multi-Center, Open Label, Single-Group Trial to Investigate the Efficacy and Safety of MK-8962 (Corifollitropin Alfa) in Combination With Human Chorionic Gonadotropin (hCG) for Initiation or Restoration of Puberty as Assessed by Increased Testicular Volume in Adolescent Males 14 to <18 Years Old With Hypogonadotropic Hypogonadism (MK-8962-043)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Male
• Age: 14 Years – 17 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hypogonadotropic Hypogonadism

Interventions

Type	Name	Description
DRUG	Corifollitropin alfa	CFA administered 100 μg (if body weight ≤60 kg) or 150 μg (if body weight \>60 kg) by SC injection, once every 2 weeks for 64 weeks (Day 1, Week 0 through Week 64).
DRUG	hCG	hCG 500-5000 IU reconstituted with 1 ml of 0.9% sodium chloride solution, as a SC injection twice a week for 52 weeks (last day of Week 12 through Week 64).

Timeline

• Start date: 2017-02-02
• Primary completion: 2020-05-05
• Completion: 2020-05-05
• First posted: 2017-01-12
• Last updated: 2024-05-23
• Results posted: 2021-04-08

Locations

15 sites across 6 countries: Brazil, Denmark, Italy, Mexico, Russia, South Africa

Regulatory

• FDA-regulated drug study