The contraceptive vaginal ring Ornibel® improves the menstrual cycle profiles in women: data of an observational study

Objective The observational study aimed to evaluate the menstrual bleeding profiles and physician diagnosed vaginal infections in women using the vaginal contraceptive ring Ornibel® in a real-world setting.

Methods 103 women between 18 and 45 years that used Ornibel® as contraceptive for at least 6 months were recruited for this non-interventional retrospective, multi-center study. Patients filled patient questionnaires to evaluate the menstrual cycle characteristics and physicians diagnosed vaginal infections. The change in menstrual bleeding profiles and menstrual bleeding associated pain was assessed via visual analogue scales (VAS).

Results 100 women (mean age of 28.64 ± 7.49 years; mean BMI of 23.18 ± 3.37 kg/m²) were eligible for analysis. During the first 6 months of Ornibel® usage 73 of 100 women experienced 6 menstrual bleedings with a median bleeding duration of 4 days. Menstrual flow and dysmenorrhea reduced significantly during the treatment (median of menstrual flow: before: 50 points VAS, after: 34points VAS; median of dysmenorrhea: before = 42.5 points VAS, after = 20points VAS; p < 0.001 for both parameters). Improvement was observed early within the first three months of usage. The percentage of women with no intermenstrual bleedings increased from 79 % to 88 % with Ornibel® while the percentage of women with intermenstrual bleeding significantly decreased from 21 % to 12 % (p < 0.022). Seven women experienced a mild or moderate physician diagnosed vaginal infection.

Conclusions Ornibel® is a new vaginal contraceptive ring. The first real-world data demonstrates that Ornibel® improves the menstrual cycle profile of women using the ring as contraceptive method

Interessenkonflikt

Anna Müller, Manuela Sailer und Pedro-Antonio Regidor sind Angestellte der Exeltis Germany GmbH. Alle anderen Autoren haben erklärt, dass kein Interessenkonflikt besteht.

Publication History

Article published online:
07 October 2020