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A Phase III, Multi-center, Open Label, Uncontrolled Trial to Investigate the Efficacy and Safety of MK-8962 (Corifollitropin Alfa) in Combination With Human Chorionic Gonadotropin (hCG) in Inducing Increased Testicular Volume and Spermatogenesis in Adult Men With Hypogonadotropic Hypogonadism Who Remain Azoospermic When Treated With hCG Alone (Phase III; Protocol No. MK-8962-031-00 [Also Known as SCH 900962, P07937])

Trial Profile

A Phase III, Multi-center, Open Label, Uncontrolled Trial to Investigate the Efficacy and Safety of MK-8962 (Corifollitropin Alfa) in Combination With Human Chorionic Gonadotropin (hCG) in Inducing Increased Testicular Volume and Spermatogenesis in Adult Men With Hypogonadotropic Hypogonadism Who Remain Azoospermic When Treated With hCG Alone (Phase III; Protocol No. MK-8962-031-00 [Also Known as SCH 900962, P07937])

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 May 2022

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At a glance

  • Drugs Corifollitropin alfa (Primary) ; Chorionic gonadotropin
  • Indications Hypogonadism
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Merck & Co; Merck Sharp & Dohme; Organon
  • Most Recent Events

    • 06 May 2016 Time frame for primary efficacy endpoint changed from 52 weeks to 57 weeks.
    • 06 May 2015 Status changed from active, no longer recruiting to completed as per ClinicalTrials.gov record.
    • 15 Jul 2014 Planned End Date changed from 1 Mar 2015 to 1 Apr 2015 according to ClinicalTrials.gov record.
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