Multicenter, international observational study on quality of life and acceptability of a vaginal contraceptive ring containing etonogestrel/ethinylestradiol 11.00/3.474 mg over six months of use

S. Palacios, J. Algorta, E. Colli, P.-A. Regidor, M. Mayr, T. Roemer

Instituto Palacios, Salud y Medicina de la Mujer, Madrid, Spain. pedro-antonio.regidor@exeltis.com

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• Gynecology

OBJECTIVE: The current post-market study aimed at analyzing women’s menstrual bleeding intensity, vaginal infections, and quality of life parameters using the contraceptive vaginal ring Ornibel®.

PATIENTS AND METHODS: In Germany and Spain, a multicenter study of healthy female adults (n=211) aged 18 to 45 used the vaginal ring Ornibel® for at least six months. Data collection was conducted using a patient questionnaire. The menstrual bleeding intensity was analyzed using visual analog scales (VAS). A Chi-square linear trend test assessed associations between quality-of-life parameters and continuation and recommendation of vaginal ring use.

RESULTS: Three out of four women experienced six menstrual bleedings during the first six months of using the vaginal ring, with a median duration of four days during the study. The use of the vaginal ring led to a significant reduction in menstrual flow intensity (from 60 VAS points to 40 VAS points, p<0.001). In the German cohort, it was shown that dysmenorrhea and unscheduled bleeding and spotting were reduced with the use of Ornibel® as well.

Most women (93.7%) agreed or strongly agreed that the vaginal ring was easy to insert, and its use was rated as comfortable or very comfortable by 97.5%. Both parameters were significantly associated with the continuation of the ring (easy to insert p=0.01, feeling comfortable: p=0.002) or its recommendation (easy to insert p=0.002, feeling comfortable: p=0.002).

CONCLUSIONS: The observational data demonstrate that the contraceptive vaginal ring provides high acceptability and comfort. It is a well-accepted contraceptive method characterized by high efficacy and positive effects on cycle control.

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