Skip to main content
OpenTrials
Completed

NCT Number: NCT01709331

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 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypogonadism Endocrine System Diseases Gonadal Disorders Hypogonadotropic Hypogonadism

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corifollitropin alfa

Drug

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

Other names: MK-8962

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)

Primary outcomes

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

    Time frame: Baseline and 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.

  2. Percentage of Participants With Anti-Corifollitropin Alfa Antibodies

    Time frame: Up to Week 57

    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.

Secondary outcomes

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

    Time frame: Up to Week 52

    Semen samples were produced by masturbation after at least 48 hours of sexual abstinence and collected for evaluation in the pretreatment phase at Week -1, and during the combined treatment phase at Weeks 16, 28, 40, and 52.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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])

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 18, 2012
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.