Organon has announced positive interim Organon MIUDELLA Phase 3 results covering six years of use. Sebela Women’s Health will present the findings at the 2026 Society of Family Planning (SFP) Annual Meeting. The meeting takes place from October 17 to 19, 2026, in San Francisco, California.
MIUDELLA is an intrauterine device (IUD) that does not contain hormones made of copper and is meant for use as a contraceptive. The Phase 3 study intends to assess how effective and safe this IUD is in its long-term use. At the same time, the company known as Organon owns the exclusive rights to use the IUD and has obtained them from Sebela Women’s Health and their subsidiary in June of 2026. The most recent findings, described above, provide new information regarding contraception in the long term, while, in addition to that, no new safety incidents have been noted in recent three years of additional use.
Juan Camilo Arjona Ferreira, MD, Head of Research & Development and Chief Medical Officer at Organon, commented on the results.
“These interim Phase 3 results add to the clinical evidence for MIUDELLA and represent an important milestone in the ongoing study,” said Juan Camilo Arjona Ferreira, MD, Head of Research & Development and Chief Medical Officer at Organon. “The findings support the FDA review of the supplemental application as we work toward our ambition of expanding hormone-free contraceptive options.”
Phase 3 Study Evaluates MIUDELLA Over Six Years
Sebela Women’s Health is conducting the prospective, single-arm Phase 3 study across 42 sites in the United States. The research evaluates MIUDELLA’s contraceptive efficacy and safety through six years of use. Researchers assessed six-year outcomes across two study populations. The evaluable-for-pregnancy population included 465 of the 1,397 enrolled participants. Meanwhile, the safety population included 592 of the 1,601 enrolled participants.
The cumulative six-year Pearl Index was 0.93 (95% confidence interval [CI]: 0.62-1.34). Furthermore, the cumulative Kaplan-Meier pregnancy rate is at 3.9% (95% CI: 2.7-5.8%) at six years. These outcomes demonstrate the efficient contraception of MIUDELLA. Still, the trial is ongoing, with participants being followed.
The researchers evaluated treatment-emergent adverse events that occurred throughout the six years. Participants experienced heavy menstrual bleeding, dysmenorrhea, and pelvic discomfort. Furthermore, adverse events related to bleeding and discomfort prompted some subjects to discontinue their participation. Specifically, 139 (8.7%) participants discontinued their involvement in the study in the first year. In contrast, 11 (1.9%) subjects discontinued their participation in the sixth year. Overall, the results contribute to understanding the clinical profile of the hormone-free copper IUD and inform experiences over an extended period of use.
Presentation at the 2026 Society of Family Planning Annual Meeting
Sebela Women’s Health will present the interim Phase 3 findings during the 2026 Society of Family Planning Annual Meeting. The presentation will share efficacy and safety data covering six years of MIUDELLA use.
Presentations
Title: Efficacy and Safety of a Novel Hormone-Free Intrauterine Device Over 6 Years: Interim Phase 3 Study Results
Meeting: 2026 Society of Family Planning Annual Meeting
Date: October 17, 2026
Presentation Time and Location: 6 p.m. PT; Exhibit Hall
The presentation will provide study results with extended follow-up. Furthermore, the presentation will also provide insight into the contraceptive device and the long-term use of hormone-free contraception. The study will look at the contraceptive efficacy and safety of the drug. Therefore, the study provides additional clinical information for professionals looking into hormone-free methods of contraception.
FDA Reviews MIUDELLA Application for Six-Year Use
The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for MIUDELLA for review. The application seeks an extended duration of use of up to six years. The FDA’s Prescription Drug User Fee Act (PDUFA) action is expected during the second quarter of calendar year 2027. This review represents an important regulatory milestone for MIUDELLA.
Meanwhile, the ongoing Phase 3 study continues to generate long-term clinical data. The additional findings may help inform the broader understanding of the device’s safety and efficacy.
His statement highlights the importance of continued clinical research. Additionally, it emphasizes Organon’s goal of expanding access to hormone-free contraception.
Company Leaders Highlight Continued Research Progress
Kelly Culwell, MD, Chief Medical Officer and Head of Research and Development at Sebela Women’s Health, also discussed the significance of the findings.
“Reaching 6 years of follow-up reflects the continued commitment of the participants, investigators, and study teams involved in this ongoing Phase 3 program,” said Kelly Culwell, MD, Chief Medical Officer and Head of Research and Development at Sebela Women’s Health. “These findings provide valuable long-term data and contribute to the understanding of participant experience over time. We are grateful to everyone who has made this research possible.”
The study’s continued follow-up reflects the contributions of participants and research teams. Furthermore, the results provide additional information about the device’s performance over an extended period. Organon and Sebela Women’s Health continue to advance the clinical evaluation of MIUDELLA. Their work contributes to research into non-hormonal contraception and long-term contraceptive options.
MIUDELLA REMS Requirements and Safety Information
MIUDELLA’s prescribing label includes a Risk Evaluation and Mitigation Strategy (REMS). The program is open for enrollment at www.miudellarems.com. Healthcare providers must complete REMS enrollment before ordering and inserting MIUDELLA. In addition, healthcare settings that dispense or insert the device must enroll through an Authorized Representative.
The MIUDELLA REMS program aims to reduce the risk of complications caused by improper insertion. Specifically, it addresses insertion by healthcare providers who lack the required training. These requirements form an important part of the product’s risk-management framework. Therefore, healthcare providers and participating facilities must follow the applicable enrollment requirements before using the device.
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News Source: Businesswire.com
