Phase 3 N=18 Treatment

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)

Hypogonadism · Hypogonadotropic Hypogonadism

Bottom Line

View on ClinicalTrials.gov: NCT01709331 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2016

Primary outcome: Primary: Change From Baseline in Log-Transformed Testicular Volume at Week 52 — 2.3 Fold change

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Corifollitropin alfa (Drug); hCG (Drug)
Age: Adult · 18+ yrs
Sex: Male
Sponsor: Organon and Co
Primary completion: Apr 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Log-Transformed Testicular Volume at Week 52	2.3	—
PRIMARY Percentage of Participants With Anti-Corifollitropin Alfa Antibodies	—	—
SECONDARY Percentage of Participants With Induced Spermatogenesis Resulting in a Sperm Count ≥1x10^6/mL at or Before Week 52	77.8	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01709331). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.