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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01709331
First received: October 16, 2012
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

This study will assess if 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.


Condition Intervention Phase
Hypogonadism
Hypogonadotropic Hypogonadism
Drug: MK-8962
Drug: hCG
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Multi-center, Open Label, Uncontrolled Trial to Investigate the Efficacy and Safety of MK-8962 (Corifollitropin Alfa) in Combination With Human Chorionic Gonadotropin (hCG) in Inducing Increased Testicular Volume and Spermatogenesis in Adult Men With Hypogonadotropic Hypogonadism Who Remain Azoospermic When Treated With hCG Alone (Phase III; Protocol No. MK-8962-031-00 [Also Known as SCH 900962, P07937])

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change from Baseline in Log-transformed Testicular Volume [ Time Frame: Baseline (Day 1) and Week 52 ] [ Designated as safety issue: No ]
  • Percentage of Participants with anti-MK-8962 Antibodies [ Time Frame: up to 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of Participants with Induced Spermatogenesis Resulting in a Sperm Count ≥ 1x10^6/mL [ Time Frame: up to 52 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: February 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-8962
MK-8962 to be injected once every other week in the morning in accordance with the hCG administration scheduled and dependent on individual participant's preference
Drug: MK-8962
MK-8962, 150 μg corifollitropin alfa per 0.5 mL subcutaneous (SC) injection, once every 2 weeks for 52 weeks
Drug: hCG
hCG, 1500-3000 international units (IU), SC injection twice a week; administered alone for 16 weeks (pre-treatment phase) and in combination with MK-8962 for 52 weeks (combined treatment phase)

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01709331     History of Changes
Other Study ID Numbers: P07937, 2012-001258-25, MK-8962-031
Study First Received: October 16, 2012
Last Updated: July 15, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014