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)

Organon

Status and phase: Completed; Phase 3

Conditions: Hypogonadotropic Hypogonadism; Hypogonadism

Treatments: Drug: hCG; Drug: Corifollitropin alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT01709331

MK-8962-031 (Other Identifier)

2012-001258-25 (EudraCT Number)

P07937

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Corifollitropin alfa 150 μg + hCG

Experimental group

Description:

During a 16-week pretreatment phase, participants will receive twice-weekly subcutaneous (SC) injections of hCG 1500 or 3000 international units (IU). Eligible participants will then be enrolled in the combined treatment phase in which they will receive a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants will continue to receive twice-weekly hCG injections on the same schedule as the pretreatment phase.

Treatment:

Drug: Corifollitropin alfa

Drug: hCG