Theramex has announced that results from the post-authorisation safety study (PASS) for Zoely® (NOMAC-E2) have been submitted 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, 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
Professor Luis Iñaki Lete, Department of Gynecology, University Hospital Araba, Vitoria, Spain said: “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
References:
- gov identifier: NCT01650168
- Zoely® SMPC. Available at: https://www.medicines.org.uk/emc/product/3038/smpc. Last accessed April 2021.
- Reed S et al, A ‘Real-World’ study population of NOMAC-E2 users and COC-LNG users: Baseline characteristics from the multinational PRO-E2 study. Pharmacoepidemiol Drug Saf. 2020;29(Suppl. 3):4
- Gaussem, P et al. Thromb Haemost 2011;105:3
- https://www.prnewswire.co.uk/news-releases/theramex-acquires-commercial-rights-for-oral-contraceptive-zoely-845938454.html