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)

NCT01709331 | Completed Phase 3 Results

• 3 other identifiers: P079372012-001258-25MK-8962-031
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Log-Transformed Testicular Volume at Week 52

  Participants underwent testicular ultrasound in the pretreatment phase at Weeks -16, -8, -1; and during the combined treatment phase at Baseline (predose, Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52. The testicular volume was measured as the sum of volumes of left and right testes. The mean change from Day 1 in log-transformed testicular volume was analyzed using a mixed model with a fixed effect for time point and a random effect for the participant. For each time point, the mean change from Day 1 to that time point and the associated 95% confidence interval (CI) was calculated. The geometric mean fold change in testicular volume and its 95% CI was obtained by exponentiation.

  Baseline and Week 52

• Percentage of Participants With Anti-Corifollitropin Alfa Antibodies

  Blood samples were collected for assessment of anti-corifollitropin alfa antibodies in the pretreatment phase at Week -16 and Week -1; during the combined treatment phase at Weeks 4, 16, 28, 50, 52; and at the post-treatment follow-up visit, which could occur from Week 53 up to Week 57.

  Up to Week 57

Secondary Outcomes (1)

• Percentage of Participants With Induced Spermatogenesis Resulting in a Sperm Count ≥1x10^6/mL at or Before Week 52

  Up to Week 52

Study Arms (1)

Corifollitropin alfa 150 μg + hCG

EXPERIMENTAL

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.

Drug: Corifollitropin alfa; Drug: hCG

Interventions

Corifollitropin alfa DRUG

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

Also known as: MK-8962

Corifollitropin alfa 150 μg + hCG

hCG 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)

Corifollitropin alfa 150 μg + hCG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  PMID: 28270212 RESULT

MeSH Terms

Conditions

Hypogonadism

Interventions

follicle stimulating hormone, human, with HCG C-terminal peptide

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: October 18, 2012
• Study Start: February 11, 2013
• Primary Completion: April 8, 2015
• Study Completion: April 8, 2015
• Last Updated: May 24, 2024
• Results First Posted: May 9, 2016

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share