Organon reports positive six-year interim Phase 3 results for Miudella IUD
OGN•Organon reported positive interim Phase 3 results showing MIUDELLA’s contraceptive efficacy through six years. The FDA accepted an application to extend its use from three years, with a decision expected in the second quarter of 2027.
1. Six-year interim results
Organon said interim Phase 3 results showed contraceptive efficacy for its hormone-free copper IUD, MIUDELLA, through six years. Bleeding- and pain-related discontinuations declined over time; reported adverse events included heavy menstrual bleeding, menstrual pain and pelvic discomfort.
2. FDA application and presentation
The FDA accepted an application to extend MIUDELLA’s indicated use from three years to six years, with a decision expected in the second quarter of 2027. Sebela Women's Health will present the findings on October 17, 2026, at the Society of Family Planning Annual Meeting in San Francisco. Organon exclusively licensed MIUDELLA globally from Sebela Women's Health in June 2026.
