NCT02817841

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

A Multicenter, Open-label, Single-Arm Study to Evaluate the Contraceptive Efficacy and Safety of a Combined Oral Contraceptive Containing 15 mg Estetrol and 3 mg Drospirenone

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,148 (actual)
• Sponsor: Estetra · Industry
• Sex: Female
• Age: 16 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	15 mg E4/3 mg DRSP	15 mg estetrol and 3 mg drospirenone tablets administered once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.

Timeline

• Start date: 2016-08-30
• Primary completion: 2018-10-16
• Completion: 2018-11-16
• First posted: 2016-06-29
• Last updated: 2020-02-10
• Results posted: 2019-11-06

Locations

2 sites across 2 countries: United States, Canada