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)
CompletedPhase 3Results postedLast updated 24 May 2024
What this trial tests
Phase 3 trial testing Corifollitropin alfa in Hypogonadism in 18 participants. Completed in 8 April 2015.
Adults 18 to 50, male only, with Hypogonadism or Hypogonadotropic Hypogonadism. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Log-Transformed Testicular Volume at Week 52Primary· 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)
Group
Value
95% CI
Corifollitropin Alfa 150 μg + hCG
2.3
2.03 – 2.62
Percentage of Participants With Anti-Corifollitropin Alfa AntibodiesPrimary· 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.
Group
Value
95% CI
Corifollitropin Alfa 150 μg + hCG
0
52.4 – 93.6
Percentage of Participants With Induced Spermatogenesis Resulting in a Sperm Count ≥1x10^6/mL at or Before Week 52Secondary· 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.
Group
Value
95% CI
Corifollitropin Alfa 150 μg + hCG
77.8
52.4 – 93.6
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to Week 57.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT04695483 — Reduction of Progesterone Elevation at Trigger in POR After Long Acting COS Compared With Daily COS: a Prospective Rando
· Phase 4
· completed
NCT04482751 — The Relationship Between Serum AMH Dynamics and Early or Normal Ovarian Response to Corifollitropin Alfa
· unknown
NCT03019575 — Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adolesce
· Phase 3
· completed
NCT00702234 — Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05714 (Care Program)(P05715)
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Organon and Co
Last refreshed: 24 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01709331.