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

To investigate safety and effectiveness of NOMAC-E2 and levonorgestrel-containing COCs (COC_LNG) in users over 40. In this large, observational study, new users¹ of NOMAC-E2 and COC_LNG 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. Overall, 7,762 NOMAC-E2 and 6,059 COC_LNG users over 40 were followed-up. NOMAC-E2 showed no increased VTE risk compared to COC_LNG; confirmed events: 5 NOMAC-E2 (IR 5.9; 95% CI, 1.9–13.7) vs 4 COC_LNG (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 COC_LNG (PI 0.08; 95% CI, 0.03–0.18). No differential effect on mood and weight was observed between cohorts. NOMAC-E2 can be considered a valid alternative to COC_LNG in perimenopausal women. [ABSTRACT FROM AUTHOR]