Clinical development of a new generation etonogestrel/Ethinylestradiol vaginal ring: Comparative bioavailability and tolerability
ESC Congress Library. Regidor P. May 11, 2018; 208264
Disclosure(s): Dr Regidor is Exeltis Employee
Mr. Pedro Antonio Regidor
Mr. Pedro Antonio Regidor
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Abstract
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Objective: To show the comparative bioavailability as part of the clinical development of a recently developed contraceptive vaginal ring, compared to the reference product. Safety, tolerability and acceptability results are presented in separate communication. Design and Methods: A randomized, single dose, 2-period, 2‑sequence, 2-stage crossover, was conducted in 40 healthy females. All subjects worn each vaginal ring during 28 days in each study period separated by a washout of 28 days: Ornibel®  Exeltis, Spain (Etonogestrel/Ethinylestradiol 120/15µg/day)   developed and manufactured by Laboratorios LeonFarma SA, Spain and Nuvaring®, MSD, Spain (Etonogestrel/Ethinylestradiol 120/15µg/day). For the calculation of pharmacokinetic parameters, blood samples were collected prior to and up to 840h after each ring insertion to quantify plasma concentrations of Etonogestrel and Ethinylestradiol by means of a validated Ms/Ms HPLC method. To compare bioavailability by bioequivalence, pharmacokinetic parameters were analyzed using an ANOVA model with subject effect, treatment, period and sequence as fixed factors. The confidence interval was adjusted to 94.12% due to the 2-stages design. Safety was assessed by means of adverse events (AE) recording and clinical laboratory. Local tolerability was evaluated by vaginal examination prior and at the end of each period. Acceptability was investigated by a 5-point scale questionnaire after each ring removal. AE were classified and described according to MedDRA dictionary.  The questionnaires of local tolerability and acceptability were compared using the Cochran-Armitage Test for Trend.   Results: The bioequivalence was demonstrated in the first stage since the 94.12% Confidence Intervals of the three primary parameters laid within the 80-125% acceptance range for both, etonogestrel (Cmax: 96.81-112.20%; AUC0-504h:  98.71-108.61%; AUC0-t: 100.14-109.10%) and ethynilestradiol. (Cmax after day 1: 105.91-120.62%; AUC0-504h:  105.47-114.59%; AUC0-t: 108.31-117.61%). During the first day of use a burst effect was observed with Nuvaring® with higher level of etonogestrel (Cmax 0-24h ratio: 94.39%, 94.12CI: 89.75- 99.27%) that were significant in the case of ethinylestradiol (Cmax 0-24h ratio: 78.34%, 94.12CI: 73.55%- 83.45%). Regarding the tolerability and acceptability evaluation, the majority of the women felt comfortable using the vaginal ring, the vaginal ring did not interfere in daily activities in the majority of the women,the ring was not felt during intercourse in by the majority of women in the study. Conclusion: Ornibel® is a new generation of contraceptive vaginal ring,  bioequivalent in  efficacy and safety to reference product,very well tolerated with the advantage of a more gradual release during the first day of use
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