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Safety

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14.10.2021 - 17:15:12

Safety results from large real-world safety study in combined oral contraception published

Accessed October 2021PRO-E2 final report. Available from: http://www.encepp.eu/encepp/openAttachment/studyResult/41498;jsessionid=uW82EciuLgcm015Qta9_pO v1_2skaG629DgRqfNG6I5-i02w5oS0!2052488890Theramex. (2021) Zoely® SmPC. Available from: https://www.medicines.org.uk/emc/product/3038/smpc. Accessed October 2021Westhoff C et al. ObstetGynecol 2012; 119(5):989-99.Christin-MaitreS et al. Womens Health (Lond) 2013; 9(1): 13-23.Van Vliet HAAM, Raps M. Cochrane Database Syst Rev 2011;(11): CD009038.Duijkers IJM et al. Eur J Contracept Reprod Health Care 2010; 15(5): 314-25.Clinicaltrials.gov. (2021) Prospective Controlled Cohort Study on the Safety of a Monophasic Oral Contraceptive Containing Nomegestrol Acetate (2.5mg) and 17ß-estradiol (1.5mg) (PRO-E2). Available from: https://clinicaltrials.gov/ct2/show/study/NCT01650168 Accessed October 2021Reed, S. et al. Pharmacoepidemiol Drug Saf. 2020;29(Suppl.3):4.US Food and Drug Administration. (2018). FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone. Available from: www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-updated-information-about- risk-blood-clots-women-taking-birth-control. Accessed October 2021de Bastos, M. et al. (2014) Cochrane Database Syst Rev (3): CD010813.Faculty of Sexual & Reproductive Healthcare. FSRH Guideline Combined Oral Contraception. January 2019 (Amended November 2020).

*Specifically deep venous thrombosis of the lower extremities and pulmonary embolism

†HR adjusted for age, body mass index, current duration of hormonal contraceptive use, family history of VTE

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