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 a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced that Sebela Women’s Health will present interim results from an ongoing Phase 3 study evaluating MIUDELLA®, a hormone-free, copper intrauterine device (IUD), through 6 years of use at the 2026 Society of Family Planning (SFP) Annual Meeting, taking place October 17 to 19, 2026, in San Francisco, California. In June 2026, Organon exclusively licensed global rights to MIUDELLA from Sebela Women’s Health.
The prospective, single-arm Phase 3 study is being conducted by Sebela Women’s Health at 42 sites in the United States to evaluate the efficacy and safety of MIUDELLA through 6 years of use. The 6-year outcomes were evaluated in 465 of 1397 and 592 of 1601 enrolled participants in the evaluable-for-pregnancy and safety populations, respectively. The cumulative 6-year Pearl Index was 0.93 (95% CI, 0.62 to 1.34), and the cumulative Kaplan-Meier pregnancy rate was 3.9% (95% CI, 2.7% to 5.8%) at 6 years.
Treatment-emergent adverse events reported through 6 years included heavy menstrual bleeding, dysmenorrhea and pelvic discomfort. Bleeding- and pain-related adverse events leading to study discontinuation were observed in 139 participants (8.7%) in year 1 and 11 participants (1.9%) in year 6.1 Follow-up in the study is ongoing.
Presentation Details:
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 U.S. Food and Drug Administration (FDA) accepted for review a supplemental New Drug Application (sNDA) for MIUDELLA for an extended duration of use for up to 6 years, with Prescription Drug User Fee Act (PDUFA) action expected in the second quarter of calendar year 2027.
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.
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.
About the Ongoing Phase 3 Study of MIUDELLA
The ongoing Phase 3 study is a prospective, single-arm trial evaluating the efficacy and safety of MIUDELLA in females aged 17 to 45 years across 42 United States sites. The current interim analysis includes outcomes through 6 years of use, with follow-up continuing.
About Organon
Organon is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately, or differently affect women, while expanding access to essential treatments in over 140 markets.
About MIUDELLA
MIUDELLA is a hormone-free, low-dose copper intrauterine device (IUD) indicated for the prevention of pregnancy in females of reproductive potential for up to 3 years.2 Sebela Women’s Health developed MIUDELLA with three clinical trials in the United States in 1,904 women aged 17 to 45 years.2 The Phase 3 prospective, multicenter, single-arm, open-label study was conducted in 42 centers in the United States with a primary endpoint of contraceptive efficacy through 3 years of use as assessed by the Pearl Index (defined as the number of pregnancies per 100 women over one year).2
In the efficacy cohort of women aged 17 to 35 years from the Phase 3 study (n=1397), the first-year Pearl Index was 0.94 (95% CI, 0.43-1.78) and the cumulative 3-year Pearl Index was 1.05 (95% CI, 0.66-1.60)2 – in other words, 99% effective,
with an overall placement success rate of ~99%.3 The most common adverse reactions (≥5%) observed in clinical trials were heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, post-procedural hemorrhage, and dyspareunia.3 In the first year, 8.5% of participants across all three studies discontinued treatment due to bleeding or pain adverse reactions, which decreased to 3.2% by year 3.3 Expulsion rates related to discontinuation ranged from 1.9% in year 1 to 0.9% in year 3.3
About Sebela Pharmaceuticals
At Sebela Pharmaceuticals, we are building a leading gastroenterology company in the United States and developing innovative products in women’s health. Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals, has been innovating, developing, manufacturing, and commercializing gastroenterology products for over 40 years. Braintree has filed an NDA with FDA for tegoprazan, its lead program in GERD. In 2025 Sebela Women’s Health obtained FDA approval for Miudella (copper-containing intrauterine system), the first non-hormonal intrauterine device (IUD) for contraception approved in over 40 years. Sebela Pharmaceuticals has operations in Braintree, MA; and Dublin, Ireland.
