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)

• Status: Completed
• Trial end date: 2015-04-08
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Chorionic Gonadotropin

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