학술논문
NOMAC-E2 compares to LNG combined oral contraceptives in women over forty: real-world PRO-E2 study.
Document Type
Academic Journal
Author
von Stockum S; Berlin Center for Epidemiology and Health Research (ZEG), Berlin, Germany.; 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.; Fruzzetti F; Department of Obstetrics and Gynecology, Pisa University Hospital, Pisa, Italy.; Calaf J; Department of Obstetrics and Gynaecology, Hospital de la Santa Creu i Sant Pau, Autonomous University of Barcelona, Barcelona, Spain.; Keck C; amedes MDL, Hamburg, Germany.; Heinemann K; Berlin Center for Epidemiology and Health Research (ZEG), Berlin, Germany.
Source
Publisher: Informa Healthcare Country of Publication: England NLM ID: 8807913 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1473-0766 (Electronic) Linking ISSN: 09513590 NLM ISO Abbreviation: Gynecol Endocrinol Subsets: MEDLINE
Subject
Language
English
Abstract
Objective: To investigate safety and effectiveness of NOMAC-E2 and levonorgestrel-containing COCs (COC LNG ) in users over 40.
Methods: 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/10 4 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 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.
Conclusions: NOMAC-E2 can be considered a valid alternative to COCLNG in perimenopausal women.
Methods: In this large, observational study, new users
Results: Overall, 7,762 NOMAC-E2 and 6,059 COC
Conclusions: NOMAC-E2 can be considered a valid alternative to COC