drugset / Trial / NCT04792385

Safety, Compliance and Pharmacokinetics of Estetrol Monohydrate/Drospirenone 15/3 mg in Post-menarchal Female Adolescents

NCT04792385

Phase 3 Completed 145 enrolled Estetra
NaSingle-groupOpen-labelPrevention

Summary

To evaluate the safety, compliance, and pharmacokinetics profile of estetrol monohydrate (E4) 15 mg combined with drospirenone (DRSP) 3 mg in post-menarchal participants between the age of 12 and 17 years + 2 months.

Timeline

Start
2020-12-28
Primary completion
2023-11-24
Completion
2023-11-24

Drugs

EvaluationDrugModalityDoseRoute
Subject ESTETROL ANHYDROUS Other / unclassified 15 mg Oral
Subject drospirenone Unknown 3 mg Oral

Indications

No indication recorded.