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Extract
The primary objectives of the trial are: 1) to assess the efficacy of 150 µg MK-8962, given once every two weeks for 52 weeks - in combination with a twice weekly dose of hCG - to increase testicular volume measured as the sum of volumes of left and right testes by ultrasound in men with hypogonadotropic hypogonadism who remain azoospermic after 16 weeks of hCG alone and 2) to evaluate whether treatment with 150 µg MK-8962 for 52 weeks in combination with hCG is safe in HH men, as evaluated by the occurrence of (serious) adverse events and presence of anti-MK-8962 antibodies (pre-specified safety endpoint).
Inclusion criteria
- Hypogonadotropic hypogonadism (HH) in males may result from either absent or inadequate gonadotropin-releasing hormone (GnRH) secretion by the hypothalamus or failure of pituitary gonadotropin secretion (luteinizing hormone (LH) & follicle stimulating hormone (FSH)). HH is characterized by androgen deficiency and by inappropriately low serum concentrations of LH and FSH