Corifollitropin alfa trial in men with hypogonadotropic hypogonadism

• Research type

  Research Study

• Full title

  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])

• IRAS ID

  111967

• Contact name

  Pierre Bouloux

• Sponsor organisation

  Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

• Eudract number

  2012-001258-25

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  MK-8962 (formerly known as Org 36286/SCH 900962) is a new hormonal medication with the same function as follicle stimulating hormone (FSH), which is one of the body's own hormones. MK-8962, given as an injection under the skin, stays in the body for a longer time than other similar hormonal medications, so fewer injections are needed. MK-8962 has been an approved drug to treat infertility in women in Europe since 2010 and, since that time, has also been approved by several countries outside Europe. MK-8962 is being studied in men who do not have enough of their own FSH hormone to start and continue making sperm as a result of a condition called hypogonadotropic hypogonadism. Since treatment of HH males usually implies long-term treatment with frequent injections of FSH, the use of MK-8962 which requires fewer injections will most probably result in less treatment burden, fewer medication errors and improved compliance. This more convenient treatment regimen is of specific benefit for the adolescent population. The current trial is part of the Paediatric Investigation Plan (PIP) as agreed with the Paediatric Committee (PDCO) of European Medicines Agency (EMA) that requested a trial with MK-8962 in HH adolescent boys between 14 and 18 years of age. Since no adolescents have been exposed to MK-8962 to date, it was agreed that the efficacy and safety of MK-8962 was first to be studied in HH adult men before studying MK-8962 in adolescent boys with HH. In line with the agreed PIP, this trial is designed as a multi-center, open-label, uncontrolled trial of MK-8962 in combination with hCG to establish the benefit/risk ratio in at least 10 adult HH men before the start of the paediatric trial in HH adolescent boys.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  12/LO/1577

• Date of REC Opinion

  7 Dec 2012

• REC opinion

  Further Information Favourable Opinion