DIVISION OF REPRODUCTIVE AND UROLOGIC PRODUCTS Extended Dosing Regimens Gerald Willett MD

2 Altering the 7-Day Placebo Window 21 Days Active Combined7 Days Placebo 2 Days Placebo 5 Days of 10ug EE 3 Days Active Combined 4 Days Placebo

3 Extending Active Combined Pills > 28 days Days Active Combined7 7 (Placebo) (10 ug EE)

4 Extended Regimens Compared to the traditional 21/7 products:  these extended regimen products have been approved on similar safety and efficacy criteria  depending on dosage, may have a higher amount of hormonal exposure on a monthly basis

5 Cycle Control – 84 Day Active Regimens Proposed Benefits DemonstratedBenefits Demonstrated Drawbacks ↓ menstrual period frequency frequency ↓ overall bleeding ↓ scheduled bleeding episodes bleeding episodes ↑ unscheduled bleeding/ spotting bleeding/ spotting episodes episodes no “missed period” signal for pregnancy

6 Effects of Extended Regimens Other Menstrual–Related Symptoms Proposed Benefits Demonstrated Benefit ↓ PMDD / PMS ↓ Dysmenorrhea ↓ Migraines ↓ Epilepsy Secondary indication for Secondary indication for premenstrual dysphoric premenstrual dysphoric disorder (PMDD) disorder (PMDD)