drugset / Trial / NCT04773353

Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Indian Women

NCT04773353

Phase 3 Completed 220 enrolled Ferring Pharmaceuticals
RandomizedParallel-groupSingle-blindTreatment

Summary

To demonstrate non-inferiority of FE 999049 compared with GONAL-F with respect to ongoing pregnancy rate in women undergoing controlled ovarian stimulation.

Timeline

Start
2021-12-03
Primary completion
2023-12-12
Completion
2023-12-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Follitropin delta Protein / enzyme biologic 0.1 ug/kg Subcutaneous
Subject Follitropin delta Protein / enzyme biologic 0.19 ug/kg Subcutaneous
Subject Follitropin delta Protein / enzyme biologic 12 ug Subcutaneous
Subject Gonal-f Protein / enzyme biologic 150 iu Subcutaneous

Indications