Unintended pregnancy in users of nomegestrol acetate and 17β-oestradiol (NOMAC-E2) compared with levonorgestrel-containing combined oral contraceptives: final results from the PRO-E2 study.

Autor: Reed S; Berlin Center for Epidemiology and Health Research (ZEG), Berlin, Germany., Koro C; Merck & Co., Inc, North Wales, PA, USA., DiBello J; Merck & Co., Inc, North Wales, PA, USA., Becker K; Berlin Center for Epidemiology and Health Research (ZEG), Berlin, Germany., Bauerfeind A; Berlin Center for Epidemiology and Health Research (ZEG), Berlin, Germany., Franke C; Berlin Center for Epidemiology and Health Research (ZEG), Berlin, Germany., Heinemann K; Berlin Center for Epidemiology and Health Research (ZEG), Berlin, Germany.
Jazyk: angličtina
Zdroj: The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception [Eur J Contracept Reprod Health Care] 2021 Dec; Vol. 26 (6), pp. 447-453. Date of Electronic Publication: 2021 Oct 15.
DOI: 10.1080/13625187.2021.1988923
Abstrakt: Objective: To assess and compare the risk of unintended pregnancy in NOMAC-E2 users with levonorgestrel-containing COC (COC LNG ) users in clinical practice.
Study Design: In this observational study, new users 1 of NOMAC-E2 and COC LNG were recruited in Europe, Australia, and Latin America and followed for up to 2 years. Unintended pregnancy was expressed by the Pearl Index (contraceptive failures per 100 women-years [WY]), crude hazard ratios (HR crude ) and adjusted hazard ratios (HR adj ).
Results: Overall, 44,559 and 46,754 users were recruited to the NOMAC-E2 and COC LNG user cohorts, respectively. There were 64 unintended pregnancies in NOMAC-E2 users (0.15 per 100 WY; 95% CI, 0.11-0.19) and 200 in COC LNG users (0.41 per 100 WY; 95% CI, 0.35-0.47). The unintended pregnancy risk was statistically significantly lower in the NOMAC-E2 cohort (p<.0001) compared to the COC LNG user cohort. The HR adj of NOMAC-E2 vs COC LNG was 0.45 (95% CI, 0.34-0.60; adjusted for age, body mass index, gravidity, COC user status, education level).
Conclusions: NOMAC-E2 demonstrated superior contraceptive effectiveness compared to COC LNG , likely due to the comparatively short hormone-free interval and possibly reinforced by the long half-life of NOMAC.
Databáze: MEDLINE
Externí odkaz: