Bacterial adhesion in a new generation contraceptive vaginal ring Ornibel®: Comparison vs current contraceptive vaginal rings
ESC Congress Library. Regidor P. May 10, 2018; 208147; ESC214 Disclosure(s): Dr Regidor is an exeltis employee
Mr. Pedro Antonio Regidor
Mr. Pedro Antonio Regidor
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Abstract
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Objectives: To show the bacterial adhesion in a novel contraceptive vaginal ring Ornibel® (Exeltis Healthcare Spain), compared with Nuvaring®; MSD; Spain Design and Methods: A new contraceptive vaginal ring that releases ethinylestradiol and etonorgestrel (0,120 mg/0,015 mg for 24h) (Ornibel® Exeltis Healthcare Spain) was approved in Europe in 2017. This new vaginal ring has a novel composition on the core and the membrane. In previous studies it was demonstrated that the vaginal ring is bioequivalent to Nuvaring ®, and is very well tolerated. A study was performed to evaluate the bacterial adhesion in this new ring.  In this study the vaginal rings were aseptically sectioned into 1.0 cm segments. Suspensions of C. albicans (1 to 2 x 10e7 CFU/ml) and of L. acidophilus (1 à 2 x 10e8 CFU/ml) were prepared in co-aggregation buffer (20mM Tris HCl (pH 7,8), 0,1 mM CaCl2, 0,1 mM MgCl2, 0,015 M NaCl, 0,02% NaN3).In parallel, for the adhesion assay of L. acidophilus alone, suspensions containing 1x108 CFU/ml of L. acidophilus were prepared in co-aggregation buffer and incubated at 37°C under agitation at 100 rpm for 4h.Segments were placed in wells (24 multi-well plate) with 1ml of either the mixed suspension or the L. acidophilus suspension and further incubated for 1h at 37°C under constant agitation at 100 rpm. Quantification of CFU/ml was determined by plating serial dilutions of the resulting suspensions on agar plates (MRS or Sabouraud).Assays were made in triplicate and results are expressed as the means ± SD Results: There are no statistically significant differences between the levels of adhesion of C. albicans on the 2 materials tested when previously co-incubated with L. acidophilus. The numbers of adhering L. acidophilus when co-incubated with C. albicans showed no statistically significant difference between Nuvaring ® and Orbinel ®.The levels of adhering L. acidophilus were significantly lower after co-incubation with C. albicans with Orbinel ® (p=0.0008) ring, compared to the levels of adhesion of L. acidophilus incubated alone. No such difference was observed with the Nuvaring ® material. Conclusion: Ornibel ® is a new vaginal ring for contraception with novel polymer structure. This study demonstrates that the the   polymers used in Ornibel® did not increase the level of adhesion of c. albicans vs Nuvaring ® ring . This is the first experimental study on bacterial adhesion on the recently approved vaginal ring. Further studies should be developed to demonstrate the impact in real life.
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