drugset / Trial / NCT03738618

Recombinant FSH Investigation in the Treatment of Infertility With Assisted Reproductive Technology (ART) (RITA-2)

NCT03738618 ↗

Phase 3 Completed 588 enrolled Ferring Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This trial investigates the effects of FE 999049 compared to placebo.

Timeline

Start
2018-10-29
Primary completion
2020-12-21
Completion
2020-12-21

Outcome

Met primary endpoint

registry analysis (other test); FE 999049 (Follitropin Delta) vs Placebo; p <0.001; Treatment difference 43.3 (95% CI 36.5 to 47.6); Fisher Exact NCT03738618 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Follitropin delta Protein / enzyme biologic 6 ug Subcutaneous
Subject Follitropin delta Protein / enzyme biologic 15 ug Subcutaneous
Subject Follitropin delta Protein / enzyme biologic 24 ug Subcutaneous

Indications