{"id":2153,"date":"2021-10-14T14:17:47","date_gmt":"2021-10-14T13:17:47","guid":{"rendered":"https:\/\/pprd.theramex.com\/pt\/?p=2153"},"modified":"2021-10-14T14:17:47","modified_gmt":"2021-10-14T13:17:47","slug":"safety-results-from-large-real-world-safety-study-in-combined-oral-contraception-published","status":"publish","type":"post","link":"https:\/\/www.theramex.com\/pt\/novidades\/safety-results-from-large-real-world-safety-study-in-combined-oral-contraception-published\/","title":{"rendered":"Safety results from large real-world safety study in combined oral contraception published"},"content":{"rendered":"\n<p>For Medical &amp; Business\/Industry Trade Media and Investors outside the US and Canada Only<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The real world PRO-E2 safety study of over 101,000 women in 12 countries has confirmed that the risk of venous thromboembolism (VTE)<sup>*<\/sup> is at least as low with Zoely\u25bc<sup>\u00ae<\/sup> (NOMAC-E2) as with levonorgestrel-containing combined oral contraceptives (COC-LNG)<sup>1<\/sup><\/li>\n\n\n\n<li>The study also demonstrated a statistically significant lower risk of unintended pregnancy compared with commonly prescribed COC-LNGs<sup> 2<\/sup><\/li>\n\n\n\n<li>NOMAC-E2 is the only monophasic combined oral contraceptive (COC) to contain estrogen with an identical structure to the one naturally produced by women<sup>3,4<\/sup><\/li>\n<\/ul>\n\n\n\n<p><strong>LONDON, UK \u2013 14 October 2021. <\/strong>Theramex, a global women\u2019s health company, today announced that the safety results from the PRO-E2 real-world safety study for Zoely<sup>\u00ae<\/sup> (NOMAC-E2) have been published in The European Journal of Contraception and Reproductive Health Care (EJCRH).<sup>1<\/sup><\/p>\n\n\n\n<p>The post-authorisation safety study (PASS), known as PRO-E2, was a large, prospective, non-interventional controlled cohort study of over 101,000 women. PRO-E2 compared the risks of using NOMAC-E2 versus COCs containing levonorgestrel (COC-LNG), a commonly prescribed contraceptive.<sup>1<\/sup><\/p>\n\n\n\n<p>The primary objective of the real-world study was to assess and compare the risk of cardiovascular events* in NOMAC-E2 users with COC-LNG users. For the main clinical outcome, the risk of VTE<sup>\u2020<\/sup> was as least &nbsp;&nbsp;&nbsp;&nbsp;as low with NOMAC-E2 as with COC-LNG, consistent with findings of previous studies (0.59 &nbsp;Hazard Ratio [HR]\u2020 95% confidence interval [CI], 0.25-1.35).<sup>1<\/sup><\/p>\n\n\n\n<p>PRO-E2 also demonstrated that contraceptive failure (the risk of unintended pregnancy), a key secondary outcome, was statistically significantly lower with NOMAC-E2 compared with COC-LNG (0.45 HR\u2020, 95% CI, 0.34-0.60, [p&lt;0.0001]). Further analyses showed that the lower rate of unintended pregnancy with NOMAC-E2 was even more pronounced in women under 35 years of age.<sup>2<\/sup> The shorter hormone-free interval with NOMAC-E2, its longer half-life, and monophasic regimen may all contribute to fewer unintended pregnancies.<sup>5,6,7<\/sup> &nbsp;<\/p>\n\n\n\n<p>These results will be published in the EJCRH later this month.<\/p>\n\n\n\n<p>All 14 secondary outcomes of the study were met, with the risk of severe adverse events and depressive disorders or changes in weight or acne score with NOMAC-E2 comparable to COC-LNG.<sup>2<\/sup><\/p>\n\n\n\n<p>Dr Joaquim Calaf Alsina, Honorary Professor of Obstetrics and Gynaecology at the Autonomous University of Barcelona, Spain, said: \u201cThis is an exciting real-world study which confirms what we suspected from both the biological profile and experience of using NOMAC-E2. This contraceptive combination has at least the same risk of VTE as the preparation shown to have the lowest risk in this aspect. The data from PRO-E2 also provides patients with important and reassuring data on efficacy and other added benefits, such as improvement of acne and low impact on body weight.\u201d<\/p>\n\n\n\n<p>Ms Claudine Domoney, Consultant Gynaecologist, Chelsea &amp; Westminster Hospital, London, UK, said: \u201cContraception can be difficult for women and as clinicians we want to make it as easy as possible. In order to do this, there needs to be a range of options that offer reliable and convenient fertility control. The PRO-E2 study, which reflects the real-life experience of women, confirms that NOMAC-E2 is better at preventing unintended pregnancy than COC-LNG.\u201d<\/p>\n\n\n\n<p>Theramex CEO Robert Stewart said: \u201cThe PRO-E2 study results will build further confidence in what has already been shown to be a reliable and effective birth-control option. As a company dedicated to improving women\u2019s health, we are delighted that the wealth of evidence from this safety study can help clinicians and women make informed decisions about contraception.\u201d<br><br>The safety and efficacy publications were accepted by the EJCRH in September. The publication on safety results is available online:<br><\/p>\n\n\n\n<p><a href=\"https:\/\/www.tandfonline.com\/doi\/10.1080\/13625187.2021.1987410\">https:\/\/www.tandfonline.com\/doi\/10.1080\/13625187.2021.1987410<\/a><\/p>\n\n\n\n<p><br>The efficacy publication will be available online later this month. Both publications will be available in the printed journal in December.<\/p>\n\n\n\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<p>Results have also been submitted to the European Medicines Agency (EMA) and will be presented at the European Society of Gynecology congress in November this year.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<p>*Specifically deep venous thrombosis of the lower extremities and pulmonary embolism<\/p>\n\n\n\n<p>\u2020HR adjusted for age, body mass index, current duration of hormonal contraceptive use, family history of VTE<\/p>\n<\/div><\/div>\n\n\n\n<p><\/p>\n\n\n\n<p><strong>Contacts:<\/strong><\/p>\n\n\n\n<p>Andrew Bradley, Head of Communications, Theramex \/ <a href=\"mailto:andrew.bradley@theramex.com\">andrew.bradley@theramex.com <\/a>\/+44(0) 7864 167962<\/p>\n\n\n\n<p>Donna Gregory \/ Makara Health \/ <a href=\"mailto:donna@makarahealth.com\">donna@makarahealth.com<\/a> \/ +44(0) 7917 912 271<\/p>\n\n\n\n<p><strong>References:<\/strong><\/p>\n<\/div><\/div>\n\n\n\n<ol class=\"wp-block-list\">\n<li>Reed S et al. Eur J Contracept Reprod Health Care. Available from: <a href=\"https:\/\/www.tandfonline.com\/doi\/10.1080\/13625187.2021.1987410\">https:\/\/www.tandfonline.com\/doi\/10.1080\/13625187.2021.1987410<\/a> Accessed October 2021<\/li>\n\n\n\n<li>PRO-E2 final report. Available from: <a href=\"http:\/\/www.encepp.eu\/encepp\/openAttachment\/studyResult\/41498%3Bjsessionid%3DuW82EciuLgcm015Qta9_pOv1_2skaG629DgRqfNG6I5-i02w5oS0!2052488890\">http:\/\/www.encepp.eu\/encepp\/openAttachment\/studyResult\/41498;jsessionid=uW82EciuLgcm015Qta9_pO<\/a> <a href=\"http:\/\/www.encepp.eu\/encepp\/openAttachment\/studyResult\/41498%3Bjsessionid%3DuW82EciuLgcm015Qta9_pOv1_2skaG629DgRqfNG6I5-i02w5oS0!2052488890\">v1_2skaG629DgRqfNG6I5-i02w5oS0!2052488890<\/a><\/li>\n\n\n\n<li>Theramex. (2021) Zoely<sup>\u00ae<\/sup> SmPC. Available from: https:\/\/<a href=\"http:\/\/www.medicines.org.uk\/emc\/product\/3038\/smpc\">www.medicines.org.uk\/emc\/product\/3038\/smpc.<\/a> Accessed October 2021<\/li>\n\n\n\n<li>Westhoff C et al. Obstet Gynecol 2012; 119(5): 989-99.<\/li>\n\n\n\n<li>Christin-Maitre S et al. Womens Health (Lond) 2013; 9(1): 13-23.<\/li>\n\n\n\n<li>Van Vliet HAAM, Raps M. Cochrane Database Syst Rev 2011; (11): CD009038.<\/li>\n\n\n\n<li>Duijkers IJM et al. Eur J Contracept Reprod Health Care 2010; 15(5): 314-25.<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>For Medical &amp; Business\/Industry Trade Media and Investors outside the US and Canada Only LONDON, UK \u2013 14 October 2021. Theramex, a global women\u2019s health company, today announced that the safety results from the PRO-E2 real-world safety study for Zoely\u00ae (NOMAC-E2) have been published in The European Journal of Contraception and Reproductive Health Care (EJCRH).1 [&hellip;]<\/p>\n","protected":false},"author":31,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-2153","post","type-post","status-publish","format-standard","hentry","category-uncategorised"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Safety results from large real-world safety study in combined oral contraception published - Theramex Portugal<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.theramex.com\/pt\/novidades\/safety-results-from-large-real-world-safety-study-in-combined-oral-contraception-published\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Safety results from large real-world safety study in combined oral contraception published - Theramex Portugal\" \/>\n<meta property=\"og:description\" content=\"For Medical &amp; Business\/Industry Trade Media and Investors outside the US and Canada Only LONDON, UK \u2013 14 October 2021. 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