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)

NCT ID: NCT01709331

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-11
• Study Completion Date: 2015-04-08

Brief 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.

Conditions

Hypogonadism; Hypogonadotropic Hypogonadism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Corifollitropin alfa 150 μg + hCG

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.

Group Type: EXPERIMENTAL

Corifollitropin alfa

Intervention Type: DRUG

Corifollitropin alfa 150 μg by SC injection, once every 2 weeks for 52 weeks

hCG

Intervention Type: DRUG

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)

Interventions

Corifollitropin alfa

Corifollitropin alfa 150 μg by SC injection, once every 2 weeks for 52 weeks

Intervention Type: DRUG

hCG

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)

Intervention Type: DRUG

Other Intervention Names

MK-8962

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Nieschlag E, Bouloux PG, Stegmann BJ, Shankar RR, Guan Y, Tzontcheva A, McCrary Sisk C, Behre HM. An open-label clinical trial to investigate the efficacy and safety of corifollitropin alfa combined with hCG in adult men with hypogonadotropic hypogonadism. Reprod Biol Endocrinol. 2017 Mar 7;15(1):17. doi: 10.1186/s12958-017-0232-y.

Reference Type: RESULT

PMID: 28270212 (View on PubMed)

Other Identifiers

2012-001258-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MK-8962-031

Identifier Type: OTHER

Identifier Source: secondary_id

P07937

Identifier Type: -

Identifier Source: org_study_id