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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)

NCT01709331 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-05-24

Study results available
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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.

Conditions

  • Hypogonadism
  • Hypogonadotropic Hypogonadism

Interventions

DRUG

Corifollitropin alfa

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

DRUG

hCG

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)

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-11
Primary Completion
2015-04-08
Completion
2015-04-08

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01709331 on ClinicalTrials.gov