Dr Franca Fruzzetti2, Dr Klaas Heinemann1, Dr Joaquim Calaf3, Professor Dr. med Christopher Keck4, Dr Anja Bauerfeind1, Ms Kirsten Becker1, Dr Suzanne Reed1, Dr Cristian Franke1
1Berlin Center for Epidemiology and Health Research (ZEG), Berlin, Germany, 2University Hospital Santa Chiara de Pisa, Pisa, Italy, 3Hospital de la Santa Creu i Sant Pau, Autonomous University of Barcelona, Barcelona, Spain, 4amedes MDL, Hamburg, Germany
Venous thromboembolism (VTE) is a rare serious complication of Combined Oral Contraceptives (COCs)
Objective
To investigate the safety, effectiveness and perimenopausal symptoms in NOMAC-E2 users and levonorgestrel-containing COC (COCLNG) users > 40 years.
Methods
101,498 new users¹ of NOMAC-E2 and COCLNG. Women from Europe, Australia, and Latin America followed-up via questionnaires up to two years. Non-inferiority design assessed the risk of VTE (DVT and PE). Unintended pregnancy – Pearl Index (PI; number of contraceptive failures per 100 women-years [WY]). Mood – questionnaire at baseline and follow-up. Weight change – mean change in percentage of body weight from baseline.
Population
7,762 NOMAC-E2 and 6,059 COCLNG > 40 years
Interventions
NOMAC-E2; COCLNG
Main Outcome Measures
VTE, unintended pregnancy, mood changes, weight
Results
NOMAC-E2 – no increased VTE risk compared to COCLNG; Unintended pregnancy rates similar; No adverse effect on mood and weight observed.
Conclusion
No substantial differences between women using NOMAC-E2 or COCLNG in VTE risk, contraceptive effectiveness and symptoms in women transitioning to menopause were found. NOMAC-E2 can be considered an alternative to the gold standard in this population.
1First users of an eligible COC or restarting with an eligible COC after a break of at least 2 months.
Biography:
Klaas Heinemann is a physician and epidemiologist, Managing Director of ZEG Berlin since 2009 and sits on the Kantar Health Europe management board.
Klaas trained in internal medicine at Charite University Hospital, Berlin, completing postgraduate masters degrees in business administration (Berlin School of Economics, Berlin), and epidemiology (London School of Hygiene and Tropical Medicine, London).
Previously he worked in the US and Germany as a Medical Expert in Global Medical Affairs at Schering AG and later Bayer Pharma, planning and managing clinical research focusing on Phase III clinical studies and post-market phase IV study design.