Hormone-Free IUD Shows Six-Year Results in New Study

Organon said interim results from an ongoing Phase 3 study support longer use of MIUDELLA, a hormone-free IUD that uses a low dose of copper to prevent pregnancy. Sebela Women's Health presented the six-year findings at the Society of Family Planning Annual Meeting in San Francisco, after Organon licensed global rights to the device from Sebela in June. The company announced the results on October 16, and the meeting ran from October 17 to October 19.

What the six-year study found

The study was conducted at sites across the United States and measured pregnancy prevention over an extended period. According to Organon, the cumulative Pearl Index through six years was 0.93, a standard measure that counts pregnancies per 100 women over one year. The cumulative pregnancy rate at six years was 3.9 percent, according to the company. Follow-up in the study is still under way, so the six-year figures are interim results rather than a final readout.

For people weighing non-hormonal options, the hormone-free IUD offers contraception without daily pills or systemic hormones. MIUDELLA is currently approved in the United States for prevention of pregnancy for up to three years, according to Organon. The new data are part of a request to extend that approved duration, and the Food and Drug Administration has accepted a supplemental application for review.

The hormone-free IUD entered the market after a long gap in non-hormonal options. Sebela Women's Health obtained approval for the device in 2025, and Organon described it at the time as the first non-hormonal intrauterine device for contraception approved in more than four decades. That history matters for patients who want long-acting contraception but do not want a hormonal method, because older copper devices have been available for years while newer designs have been slower to reach clinics.

Safety and access

Safety results through the extended period showed no new safety signals, Organon said. The most common problems reported in the study were heavy menstrual bleeding, pain during menstruation, and pelvic discomfort. Problems linked to bleeding or pain led some participants to stop using the device, and that pattern was more common early in the study than later on, according to the company. In the first year, bleeding- and pain-related events led 8.7 percent of participants to stop, compared with 1.9 percent in the sixth year.

Access to the hormone-free IUD remains restricted to trained providers. MIUDELLA is available only through a Risk Evaluation and Mitigation Strategy program that requires providers to complete training before insertion, a step meant to reduce complications from improper placement. Providers and clinics that dispense the device must enroll in the program before ordering or inserting it, according to Organon.

What happens next

Regulators are now reviewing whether the approved use period should be extended. Organon said a decision under the Prescription Drug User Fee Act is expected in the second quarter of next year. If regulators approve the longer duration, people using the hormone-free IUD would not need a replacement as soon, which could reduce clinic visits and interruptions in contraception.

Long-acting contraception has drawn interest from younger adults who want reliable pregnancy prevention without remembering a daily method. A hormone-free IUD can appeal to people who prefer to avoid hormones for medical or personal reasons, while still wanting a method that works for years after placement. The six-year data give clinicians and patients more information about how the device performs over a longer stretch of use, and they give couples a clearer basis for comparing methods during a clinic visit.

Questions remain about who benefits most from extended use and how bleeding or pain affects continuation over time. Researchers will continue to track outcomes as follow-up proceeds, and the company has not yet reported final results for the full study period. For now, the interim findings suggest the hormone-free IUD remained effective through six years in the study, with a safety pattern consistent with earlier results, according to Organon.

Anyone considering the hormone-free IUD should discuss bleeding patterns, pain, and the insertion process with a clinician, since those factors often shape whether a method feels workable in daily life. A clinician can also explain how the restricted training program affects where the device can be placed and what follow-up is needed after insertion. That conversation, paired with the new six-year data, can help patients decide whether a longer-lasting non-hormonal option fits their plans.

Readers looking for related coverage can read GenZ NewZ reporting on campus sexual health access and on sexual health after cancer treatment. The full announcement is available from Organon on Business Wire.