Estetrol-Drospirenone combination oral contraceptive: a clinical study of contraceptive efficacy, bleeding pattern and safety in Europe and Russia.

ABSTRACT:

Objectives

To assess the contraceptive efficacy, bleeding pattern and safety of a combined oral contraceptive containing estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg.

Design

Multicenter, open-label, phase 3 trial.

Setting

Sixty-nine sites in Europe and Russia.

Population

Sexually active women aged 18-50 years with regular menstrual cycles and body mass index ≤35 kg/m² .

Methods

E4/DRSP was administered in a 24 active/4 placebo regimen for up to 13 cycles. Visits were scheduled during Cycles 2, 4, 7 and 10 and after completing treatment during which adverse events (AEs) were collected. Participants recorded medication intake, vaginal bleeding/spotting, use of other contraceptive methods and sexual intercourse on a daily diary.

Main outco

SUBMITTER: Gemzell-Danielsson K 

PROVIDER: S-EPMC9290720 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature