A Study of the Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Ch… (NCT01709331) | Clinical Trial Compass
CompletedPhase 3
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)
18 participantsStarted 2013-02-11
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Change From Baseline in Log-Transformed Testicular Volume at Week 52
Timeframe: Baseline and Week 52
2
Percentage of Participants With Anti-Corifollitropin Alfa Antibodies