Theramex, a global women’s health company, today announced that the safety results from the PRO-E2 real-world safety study for Zoely® (NOMAC-E2) have been published in The European Journal of Contraception and Reproductive Health Care (EJCRH).1
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.1
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† was as least as low with NOMAC-E2 as with COC-LNG, consistent with findings of previous studies (0.59 Hazard Ratio [HR]† 95% confidence interval [CI], 0.25-1.35).1
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†, 95% CI, 0.34-0.60, [p<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.2 The shorter hormone-free interval with NOMAC-E2, its longer half-life, and monophasic regimen may all contribute to fewer unintended pregnancies.3,4,5 These results will be published in the EJCRH later this month.
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.2
Theramex CEO Robert Stewart said: “The 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’s health, we are delighted that the wealth of evidence from this safety study can help clinicians and women make informed decisions about contraception.”
The safety and efficacy publications were accepted by the EJCRH in September. The publication on safety results is available online here. The efficacy publication will be available online later this month. Both publications will be available in the printed journal in December. 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.
*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
Read the full efficacy publication here.
Read more news from the Primary Care Women’s Health Forum here.
- Reed S et al. Eur J Contracept Reprod Health Care. Available from: https://www.tandfonline.com/doi/10.1080/13625187.2021.1987410 Accessed October 2021
- PRO-E2 final report. Available from: http://www.encepp.eu/encepp/openAttachment/studyResult/41498;jsessionid=uW82EciuLgcm015Qta9_pO v1_2skaG629DgRqfNG6I5-i02w5oS0!2052488890 Accessed October 2021
- Christin-Maitre S 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.