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)
Condition: Hypogonadism; Hypogonadotropic Hypogonadism
MeSH terms: Hypogonadism
Intervention: Corifollitropin alfa; hCG
Intervention description: Corifollitropin alfa 150 μg by SC injection, once every 2 weeks for 52 weeks; hCG 1500 or 3000 IU by SC injection twice a week; administered alone for 16 weeks (pre-treatment phase) and then in combination with corifollitropin alfa for 52 weeks (combined treatment phase)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      This study will assess if corifollitropin alfa (MK-8962), when administered in combination
      with human chorionic gonadotropin (hCG), will increase testicular volume in men with HH who
      remain azoospermic after treatment with hCG alone.

      Hypothesis: The lower limit of the 95% confidence interval for the geometric mean increase in
      testicular volume from Day 1 to Week 52 is greater than one.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with hypogonadotropic hypogonadism, either congenital or acquired

          -  Have low circulating levels of testosterone

          -  Have low circulating levels of gonadotropins (follicle stimulating hormone [FSH];
             luteinizing hormone)

          -  Presence of both scrotal testes

          -  Have azoospermia (no measurable level of sperm)

          -  Adequate replacement of other pituitary hormones

          -  Good general physical and mental health

        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