At a glance
ClinicalIndex Comparison Record- ✓Diagnosed with hypogonadotropic hypogonadism (congenital or acquired, onset prior to puberty)
- ✓Bilateral pre-gonadarche testes: testicular volume <4.0 mL each (or <4.0 mL in one and 4–8 mL in the other, with no history of primary testicular disorder)
- ✓Total testosterone <8.3 nmol/L (lower limit of normal for healthy adult male)
- ✓FSH ≤2 IU/L and LH ≤2 IU/L
- ✕History of bilateral cryptorchidism or unilateral cryptorchidism treated after age 2 years
- ✕History or presence of clinically significant testicular problems (epididymitis, orchitis, testicular torsion, varicocele Grade III, testicular atrophy, occlusive azoospermia, etc.) or known damage to vas deferens
- ✕Untreated or inadequately treated pituitary or hypothalamic tumor
- ✕Uncontrolled endocrinopathies (thyroid, adrenal, pituitary) not on stable replacement
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Multi-Center, Open Label, Single-Group Trial to Investigate the Efficacy and Safety of MK-8962 (Corifollitropin Alfa) in Combination With Human Chorionic Gonadotropin (hCG) for Initiation or Restoration of Puberty as Assessed by Increased Testicular Volume in Adolescent Males 14 to <18 Years Old With Hypogonadotropic Hypogonadism (MK-8962-043)
In Brief
A Phase 3 clinical trial evaluating Corifollitropin alfa and hCG for Hypogonadotropic Hypogonadism. Completed, enrolled 17 participants across 15 sites in 6 countries.
Detailed Summary
The purpose of the study is to investigate whether corifollitropin alfa (MK-8962), administered alone for 12 weeks and then in combination with human chorionic gonadotropin (hCG) for 52 weeks, increases the testicular volume in adolescent males aged 14 to \<18. In addition, the study will evaluate participants for safety, tolerability and for the development of corifollitropin alfa antibodies. No formal hypothesis will be tested for this estimation study
Study Details
Timeline
Interventions
CFA administered 100 μg (if body weight ≤60 kg) or 150 μg (if body weight \>60 kg) by SC injection, once every 2 weeks for 64 weeks (Day 1, Week 0 through Week 64).
hCG 500-5000 IU reconstituted with 1 ml of 0.9% sodium chloride solution, as a SC injection twice a week for 52 weeks (last day of Week 12 through Week 64).