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

PHASE3CompletedINTERVENTIONAL
Enrollment

2,148

Participants

Timeline

Start Date

August 30, 2016

Primary Completion Date

October 16, 2018

Study Completion Date

November 16, 2018

Conditions
Contraception
Interventions
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.

Trial Locations (2)

19107

Thomas Jefferson University Obstetrics and Gynecology, Philadelphia

G1S 2L6

Clinique de Santé des Femmes, Québec

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

PRA Health Sciences

INDUSTRY

lead

Estetra

INDUSTRY

NCT02817841 - E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - United States/Canada Study | Biotech Hunter | Biotech Hunter