Organon Announces Positive Interim Phase 3 Study Results for MIUDELLA®, a Hormone-Free, Intrauterine Device (IUD), Through 6 Years of Use to Be Presented at the 2026 Society of Family Planning Annual Meeting
Organon announced positive interim Phase 3 results for MIUDELLA, its hormone-free copper IUD, showing efficacy through 6 years of use with a cumulative Pearl Index of 0.93 and no new safety signals. The 6-year analysis drew on data presented at the 2026 Society of Family Planning Annual Meeting from a 42-site U.S. study conducted by Sebela Women's Health, which licensed global rights to Organon in June 2026.
Key figures
- Drug Name
- MIUDELLA
- Phase Of Trial
- Phase 3
- Pdufa date
- Q2 2027
- Study sites
- 42
- Pearl index ci
- 0.62 to 1.34
- Pearl index 6yr
- 0.93
- Enrolled safety population
- 1601
- Enrolled pregnancy population
- 1397
- Kaplan meier pregnancy rate 6yr
- 3.9%
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