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)

Exclusion Criteria

• •Primary hypogonadism, such as Klinefelter's syndrome
• •History of unilateral or bilateral cryptorchidism (maldescended testes)
• •History or presence of testicular pathology of clinical importance (e.g., epididymitis, orchitis, testicular torsion, varicocele stage III, testicular atrophy, occlusive azoospermia, etc), and/or vasectomy
• •Treated with FSH, hCG or gonadotropin-releasing hormone (GnRH) within previous 3 months or for more than 1 month within previous 6 months
• •Proven spermatogenesis with hCG treatment alone
• •Previous unsuccessful attempt with hCG in combination with human menopausal gonadotropin (hMG)/FSH to achieve spermatogenesis
• •Required a dose of hCG of more than 6000 international units (IU) per week in a previous attempt to normalize T levels
• •Untreated pituitary or hypothalamic tumor, or inadequately treated pituitary or hypothalamic tumor that is likely to progress during the study
• •History or presence (known or suspected) of testicular, prostatic or breast cancer
• •Prostate pathology of clinical importance
• •Past or present oncologic treatment (chemo/radiotherapy)
• •Diabetes mellitus
• •Clinically significant, untreated hyperprolactinaemia
• •Uncontrolled non-gonadal endocrinopathies (thyroid, adrenal, pituitary disorders)
• •Tested positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
• •User of recreational or illicit drugs or has had a recent history (within the past year) of drug abuse or dependence, or increased alcohol consumption
• •Allergy/sensitivity to gonadotropins or its/their excipients
• •Has received within previous 1 month or plans to use: Hormonal preparations other than the study medication, drugs that are known to impair testicular function, agents known to affect sex hormone secretion and/or drugs that are known or suspected to be teratogenic
• •Used any investigational drugs within three months or actively participating in another study