NOMAC-E2 compares to LNG combined oral contraceptives in women over forty: real-world PRO-E2 study

Autor: Sophia von Stockum, Kerstin Becker, Anja Bauerfeind, Christian Franke, Franca Fruzzetti, Joaquim Calaf, Christoph Keck, Klaas Heinemann
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Gynecological Endocrinology, Vol 39, Iss 1 (2023)
Druh dokumentu: article
ISSN: 09513590
1473-0766
0951-3590
DOI: 10.1080/09513590.2023.2166032
Popis: Objective To investigate safety and effectiveness of NOMAC-E2 and levonorgestrel-containing COCs (COCLNG) in users over 40.Methods In this large, observational study, new users1 of NOMAC-E2 and COCLNG were recruited in Europe, Australia, and Latin America and followed-up via questionnaires. Incidence of venous thromboembolism (VTE) was expressed as incidence rate (IR; events/104 women-years [WY]). Unintended pregnancy was expressed by the Pearl Index (PI; contraceptive failures/100 WY). Mood and weight changes were defined as mean changes in mood score and percentage of body weight.Results Overall, 7,762 NOMAC-E2 and 6,059 COCLNG users over 40 were followed-up. NOMAC-E2 showed no increased VTE risk compared to COCLNG; confirmed events: 5 NOMAC-E2 (IR 5.9; 95% CI, 1.9–13.7) vs 4 COCLNG (IR 5.9; 95% CI, 1.6–15.1). Unintended pregnancy did not differ substantially between cohorts; confirmed events: 4 NOMAC-E2 (PI 0.05; 95% CI, 0.01–0.13) vs 5 COCLNG (PI 0.08; 95% CI, 0.03–0.18). No differential effect on mood and weight was observed between cohorts.Conclusions NOMAC-E2 can be considered a valid alternative to COCLNG in perimenopausal women.
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