Europe – Etonogestrel and ethinylestradiol vaginal delivery system 0.12mg/0.015mg/day product-specific bioequivalence guidance

Requirements for bioequivalence demonstration (PKWP)

Single dose in healthy female volunteers.

Cross-over design

Additional study considerations: The authorised duration of treatment is 3 weeks. The originator product information states that the product continues to be effective if it is used for an additional 4th week. The extended ring use (of up to 28 days) should therefore be considered. A bioequivalence study for 28 days is recommended.