- The real world PRO-E2 safety study of over 101,000 women in 12 countries has confirmed that the risk of venous thromboembolism (VTE)* is at least as low with Zoely▼® (NOMAC-E2) as with levonorgestrel-containing combined oral contraceptives (COC-LNG)1
- The study also demonstrated a statistically significant lower risk of unintended pregnancy compared with commonly prescribed COC-LNGs 2
- NOMAC-E2 is the only monophasic combined oral contraceptive (COC) to contain estrogen with an identical structure to the one naturally produced by women3,4
LONDON, UK – 14 October 2021. 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 gas 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.5,6,7
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
PRO-E2 was conducted by ZEG Berlin using an active-surveillance, direct-to-patient study methodology. Women were recruited by their prescribing physician and followed for up to 2 years to observe the incidence of safety-related events. Self-reported safety events were then verified by medical source documentation.
The safety and efficacy publications were accepted by the EJCRH in September. The publication on safety results is available online:
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
References:
- 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
- Theramex. (2021) Zoely® SmPC. Available from: https://www.medicines.org.uk/emc/product/3038/smpc. Accessed October 2021
- Westhoff C et al. Obstet Gynecol 2012; 119(5): 989-99.
- 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.
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