cardiovascular system & hematology clinical medicine Combined oral contraceptives Database study Drug Utilization general & internal medicine Levonorgestrel medical and health sciences Medical emergency Multinational corporation Real world data Risk management plan Seasonique
Objective: As part of the risk management plan in Europe, this study was conducted to characterize drug utilization patterns of Seasonique, a 91-day extended levonorgestrel-containing combined oral contraceptive (COCLNG). Methods: A retrospective observational study was conducted in France, Italy and Belgium using electronic medical record databases obtained from general practitioners (GPs) in all participating countries and gynecologists in France from 2015-2018. The study population included women receiving ≥1 prescription of 91-day COCLNG during the study period. Prescribing patterns of 91-day COCLNG were examined including: (1) treatment duration; (2) indication; (3) use of combined oral contraceptive (COC) before 91-day COCLNG initiation; and (4) switch from and to combined hormonal contraceptives (CHC) or other contraceptives. Results: A total of 235, 220, 207 and 659 women using 91-day COCLNG were identified in French, Italian and Belgian GP and French gynecologist databases, respectively. Across databases, 46%-76% of women were prescribed a single 91-day COCLNG prescription and median treatment duration ranged from 3-6 months. The most common indication was contraception (42%-81%), followed by menstrual migraines (2%-14%). Use of COC during the six months prior to 91-day COCLNG initiation was 14% across GP databases, but was lower (8%) in the French gynecologist database. The frequency of switching from 91-day COCLNG to CHCs or other contraceptives was generally low (5%-12%), with the highest proportion being among patients of French gynecologists. Conclusions: Findings indicate that 91-day COCLNG was prescribed for relatively short durations and predominantly as indicated for contraception. Most results were comparable across all participating countries.