E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - United States/Canada Study

Phase 3 Completed 2148 enrolled Estetra PRA Health Sciences · collab

NaSingle-groupOpen-labelPrevention

Summary

The objectives of this study are to evaluate the contraceptive efficacy, vaginal bleeding pattern (cycle control), and the general safety and acceptability of the 15 mg estetrol (E4)/3 mg drospirenone (DRSP) combination in healthy women aged 16 to 50 years.

Timeline

Start: 2016-08-30
Primary completion: 2018-10-16
Completion: 2018-11-16

Publications

Creinin MD, Jensen JT, Chen MJ, Black A, Costescu D, Foidart JM. Combined Oral Contraceptive Adherence and Pregnancy Rates. Obstet Gynecol. 2023 May 1;141(5):989-994. doi: 10.1097/AOG.0000000000005155. Epub 2023 Apr 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ESTETROL ANHYDROUS	Other / unclassified	15 mg	Oral
Subject	drospirenone	Unknown	3 mg	Oral

Indications

No indication recorded.