CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 18 enrolled
Drug / intervention
Corifollitropin alfa +1 moredrug
Likely dose
Corifollitropin alfa 150 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01709331
NCT01709331Phase 3Completed
CompareCT.gov

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])

Organon and Co·interventional·Posted Oct 18, 2012·Updated May 24, 2024

In Brief

A Phase 3 clinical trial evaluating Corifollitropin alfa and hCG for Hypogonadism and Hypogonadotropic Hypogonadism. Completed, enrolled 18 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypogonadism, Hypogonadotropic Hypogonadism
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 18, 2012
Enrollment StartFeb 11, 2013
Primary CompletionApr 8, 2015
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 13.7 years ago

Interventions

Corifollitropin alfadrug

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

hCGdrug

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)