Results from large-scale real-world safety study for oral combination contraception pill, Zoely® (NOMAC-E2), submitted to European Medicines Agency

Results from large-scale real-world safety study for oral combination contraception pill, Zoely® (NOMAC-E2), submitted to European Medicines Agency

LONDON, UK – 27 April 2021. Theramex, a global company specialised in women’s health, announced today that they submitted results from the post-authorisation safety study (PASS) for Zoely® (NOMAC-E2) to the European Medicines Agency (EMA).¹ NOMAC-E2 (which combines nomegestrol acetate [2.5mg] and 17β-estradiol [1.5mg]), contains oestrogen with an identical structure to the one naturally produced by women.²

The prospective, non-interventional controlled cohort study, one of the largest of its kind, known as PRO E2, was designed to compare the risks of using NOMAC-E2 versus combined oral contraceptives containing levonorgestrel (COC-LNG).^1,3 The study, conducted by ZEG-Berlin, was required by the EMA and initiated in 2014 (following a precursor study, CELINA, initiated in 2012) and closed in Dec 2020.¹ The results reflect real world practice in more than 100,000 women from across Australia, Austria, Colombia, France, Germany, Hungary, Italy, Mexico, Poland, Russia, Spain, and Sweden.³

Theramex CEO Robert Stewart commented: “The strength of this study further underscores our confidence in Zoely® as an effective and reliable first-line birth-control option for all eligible women.”

Professor Luis Iñaki Lete, Department of Gynecology, University Hospital Araba, Vitoria, Spain commented: “As clinicians, real-world evidence and ongoing safety monitoring is increasingly important to the decisions we make on a day-to-day basis for our patients. Studies of this size help guide our clinical practice.”

NOMAC-E2 has previously been shown to induce significantly less change in the overall activity of the coagulation system in a study comparing it with levonorgestrel/ ethinylestradiol.⁴