Non-interventional retrospective study to evaluate menstrual bleeding profiles, tolerability and quality of life of women using the new vaginal ring Ornibel® delivering etonogestrel 0.120 mg and ethinylestradiol (EE) 0.015 mg per day

Abstract Background: To assess the menstrual cycle profile, tolerability, quality of life and sexual wellbeing in women using the vaginal contraceptive ring Ornibel®. Method: Non-interventional, retrospective, multi-center study on 103 women between 18 and 45 years old that used Ornibel® for at least 6 months. Menstrual cycle characteristics, vaginal infections and quality of life parameters were analyzed. Change in menstrual bleeding profiles and menstrual bleeding associated pain were assessed via visual analogue scales (VAS). Results: Menstrual flow and dysmenorrhea reduced significantly. The VAS score reductions were 16 and 22,5 points respectively (p < 0.001). No differences were observed between women that changed from another contraceptive method to the vaginal ring. The percentage of women without unscheduled bleedings or spotting increased from 79% to 88%. The percentage of women with unscheduled bleeding or spotting significantly decreased from 21% to 12%. Women rated the ring as very comfortable or comfortable (97%) as well as easy to insert (91%). The continuation of the usage of the ring and a recommendation for the ring were significantly associated with these two parameters. Conclusions: Ornibel® improved the menstrual cycle profile, reduced dysmenorrhea and shows a very high adherence to the use. Clinical trial register: DRKS-ID: DRKS00014982