Organon announced interim MIUDELLA trial results on October 16, 2026, providing longer-term efficacy and safety data for its hormone-free copper intrauterine device. The findings support an application under FDA review to extend use to six years; MIUDELLA is currently approved for pregnancy prevention for up to three years.
Key Takeaways
- The interim analysis reported a cumulative six-year pregnancy rate of 3.9%.
- Organon reported no new safety signals during three additional years of use, while bleeding and pain remained relevant adverse events.
- The FDA’s action on the proposed longer duration is expected in the second quarter of 2027.
Table of Contents
- MIUDELLA trial adds six-year efficacy evidence
- Safety findings include bleeding and pain withdrawals
- Longer approved use remains subject to FDA review
- Conclusion
MIUDELLA trial adds six-year efficacy evidence
Organon’s interim Phase 3 results announcement describes an ongoing prospective, single-arm study conducted by Sebela Women’s Health at 42 U.S. sites. Sebela is scheduled to present the findings at the Society of Family Planning Annual Meeting in San Francisco, which runs from October 17 to 19, 2026.
The cumulative six-year Pearl Index was 0.93, with a 95% confidence interval of 0.62 to 1.34. The Pearl Index measures pregnancies per 100 women over one year; it is distinct from the cumulative Kaplan-Meier pregnancy rate, which was 3.9% at six years, with a 95% confidence interval of 2.7% to 5.8%.
The study has no comparison arm, so the findings do not establish superiority over another contraceptive. Follow-up is continuing, and the six-year analysis covers subsets of the original efficacy and safety populations.
| Item | Details |
|---|---|
| Study age range | Females aged 17 to 45 years. |
| Six-year efficacy population | Outcomes evaluated in 465 of 1,397 enrolled participants. |
| Six-year safety population | Outcomes evaluated in 592 of 1,601 enrolled participants. |
| Scheduled presentation | October 17, 2026, at 6 p.m. PT in the meeting’s Exhibit Hall. |
Safety findings include bleeding and pain withdrawals
Organon said no new safety signals were identified during the additional three years of extended use. Treatment-emergent adverse events reported through six years included heavy menstrual bleeding, dysmenorrhea and pelvic discomfort.
Bleeding- and pain-related adverse events led to study discontinuation in 139 participants, or 8.7%, in year one and 11 participants, or 1.9%, in year six. Those percentages describe separate study years, not a cumulative withdrawal rate.
MIUDELLA carries a boxed warning about complications from improper insertion. Healthcare providers must complete the required Risk Evaluation and Mitigation Strategy enrollment and training before first use, and dispensing or insertion settings must also enroll.
Longer approved use remains subject to FDA review
The FDA has accepted a supplemental New Drug Application seeking to extend MIUDELLA’s duration of use to six years. Acceptance for review is not approval, and the current three-year indication remains separate from the longer period evaluated in the interim analysis.
Organon obtained exclusive global licensing rights to MIUDELLA from Sebela Women’s Health in June 2026. For the company, the pending application concerns a longer approved duration for an existing contraceptive, rather than initial approval of a new product.
Conclusion
The next scheduled milestone is the October 17 presentation, with study follow-up continuing. The larger regulatory question is whether the FDA will approve six-year use; agency action is expected in the second quarter of 2027.
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