drugset / Trial / NCT06173869

A Randomised Trial Comparing the Ovarian Response of a Starting Dose of Either 10 μg or 15 μg Follitropin Delta (FE 999049) to a Starting Dose of Either 150 IU or 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in China

NCT06173869

Phase 3 Completed 301 enrolled Ferring Pharmaceuticals
RandomizedParallel-groupSingle-blindTreatment

Summary

This is a phase 3b clinical trial with follitropin delta (FE 999049) and Gonal-F. The trial is a randomised, controlled, assessor-blind, parallel groups, multicentre trial comparing the ovarian response of a starting dose of either 10mg or 15 mg follitropin delta to a starting dose of either 150 IU or 225 IU Gonal-F in a long GnRH agonist protocol in women undergoing an assisted reproductive technology programme in China.

Timeline

Start
2024-03-29
Primary completion
2025-05-31
Completion
2025-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Follitropin delta Protein / enzyme biologic 10 ug Subcutaneous
Subject Follitropin delta Protein / enzyme biologic 15 ug Subcutaneous
Comparator Gonal-f Protein / enzyme biologic 150 iu Subcutaneous
Comparator Gonal-f Protein / enzyme biologic 225 iu Subcutaneous

Indications