Femme Homme
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Extrait
1. Inhibition of ovulation, which is considered confirmed if in the subset of subjects for whom the test will be performed, ovulation is observed in less than 15% of the subjects at any time during the 3 treatment cycles of the study. Ovulation is defined as two or more consecutive progesterone concentrations >16 nmol/L within 5 days, supported by ultrasound evidence of ovulation. NOTE: Ultrasound evidence of ovulation is defined as either follicular rupture, or the preceding presence of a follicular-like structure >15 mm in size. 2. Cycle control that is non-inferior to NuvaRing®, as judged by the incidence of BTB-S during Treatment Cycle 3.
Critère d'inclusion
- This is the dose-finding study on ovarian function, vaginal bleeding pattern, and pharmacokinetics associated with the use of combined vaginal rings in healthy women