Pharmacokinetic bioequivalence, safety and acceptability of Ornibel®, a new polymer composition contraceptive vaginal ring (etonogestrel/ethinylestradiol 11.00/3.474 mg) compared with Nuvaring® (etonogestrel/ethinylestradiol 11.7/2.7 mg).
Eur J Contracept Reprod Health Care
; 22(6): 429-438, 2017 Dec.
Article
en En
| MEDLINE
| ID: mdl-29336615
ABSTRACT
OBJECTIVE:
To show the clinical development of Ornibel® (ExeltisHealthcare, Spain) a contraceptive vaginal ring manufactured with a new polymer composition and containing etonogestrel/ethinylestradiol, compared to Nuvaring® (MSD, Spain). SUBJECTS ANDMETHODS:
Randomised, single dose, 2-period, 2-sequence, 2-stage crossover, comparative bioavailability study conducted in 40 healthy female subjects. All subjects received both treatments for 28 days in each of two periods, separated by a 28 days washout. Ornibel® contains etonogestrel/ethinylestradiol 11.00/3.47 mg and Nuvaring® contains etonogestrel/ethinylestradiol 11.7/2.7 mg, both rings delivering 120/15 µg/day. For the calculation of pharmacokinetic parameters, 37 blood samples were collected up to 840 h after each ring insertion to quantify plasma concentrations of etonogestrel and ethinylestradiol using a validated MS/MS-HPLC. Safety was assessed by adverse events recording, clinical laboratory and vital signs and tolerability by vaginal examination. Acceptability was investigated by a 5-point scale questionnaire.RESULTS:
Bioequivalence was demonstrated in the first stage as the 94.12% Confidence Intervals of the 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 ethinylestradiol. (Cmax 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 significantly higher level of ethinylestradiol (Cmax0-24h ratio 78.34%, 94.12CI 73.55-83.45%). Both products were well tolerated and accepted, without significant differences between them.CONCLUSION:
Ornibel® is bioequivalent to Nuvaring® in terms of efficacy, safety, tolerability and acceptability. The new polymer composition provides Ornibel® with more stability and gradual hormonal release during the first day of use, particularly for ethinylestradiol.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Desogestrel
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Anticonceptivos Femeninos
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Dispositivos Anticonceptivos Femeninos
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Estrógenos
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Etinilestradiol
Tipo de estudio:
Clinical_trials
Límite:
Adult
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Female
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Humans
Idioma:
En
Año:
2017
Tipo del documento:
Article