key: cord-0078056-4azdboed
authors: Black, Amanda; Black, Denise; Toor, Rupinder; Gersh, Richard; Bhangu, Parambir; Costescu, Dustin
title: Hands-on Training in a Virtual World: Novel Simulation-based Virtual Training for Subdermal Contraceptive Implant Placement and Removal
date: 2022-05-13
journal: J Obstet Gynaecol Can
DOI: 10.1016/j.jogc.2022.02.027
sha: 5c58b160155d276590b98e86dfc21f2146b26581
doc_id: 78056
cord_uid: 4azdboed

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Objectives: To examine efficacy and safety of a combined oral contraceptive pill containing the estetrol (E4) and drospirenone (DRSP) in a 24/4-day oral regimen.

Methods: Two parallel, multicentre, open-label, phase-3 trials (United States/Canada and Europe/Russia) enrolled healthy participants 16e50 years to use estetrol 15 mg/drospirenone 3 mg (E4/DRSP) for up to 13 cycles. Data of participants 16e35 years at screening were pooled to assess the Pearl Index (PI) in at-risk cycles (confirmed intercourse and no other contraceptive use). In addition, PI was stratified by previous hormonal contraceptive use and body mass index (BMI). Groups were compared using chi-square testing. Adverse events (AEs) were evaluated for all participants. Bleeding outcomes were evaluated in participants that started treatment and had at least 1 evaluable cycle. Mean frequency of scheduled and unscheduled bleeding and/or spotting and median duration of bleeding and/or spotting episodes were calculated.

Unscheduled bleeding/spotting frequency decreased from 27.1% in Cycle 1 to <17.5% from Cycle 5 onwards, with a median duration of 3e4 days/cycle and most episodes (62.7%) were spotting-only. Of 2234 women completing 13 cycles, 754 (34%) reported unscheduled bleeding/spotting in only 1 or 2 cycles and 911 (41%) did not report any unscheduled bleeding/spotting. The most common bleeding adverse events (AEs) considered treatment-related were 'metrorrhagia

Keywords: estetrol; oral contraceptive; bleeding profile; drospirenone -O-GYN-MD-024

Impact of a 10-Minute Educational Video Prior to Initial Consultation in a Mature Women's Health and Menopause Clinic Jeanne Bouteaud