Organon reports interim phase 3 data for MIUDELLA IUD through 6 years

MIUDELLA (Organon), a hormone-free, low-dose copper intrauterine device (IUD) had a cumulative Pearl Index of 0.93 (95% CI, 0.62-1.34) through 6 years of use, according to interim results from an ongoing phase 3 study announced by Organon on October 16, 2026. Sebela Women’s Health will present the data at the 2026 Society of Family Planning (SFP) Annual Meeting, held October 17 to 19 in San Francisco, California.¹

MIUDELLA is currently indicated for prevention of pregnancy in females of reproductive potential for up to 3 years. The FDA has accepted for review a supplemental new drug application (sNDA) to extend its duration of use to up to 6 years, with Prescription Drug User Fee Act (PDUFA) action expected in the second quarter of calendar year 2027.^1,2

How was the 6-year phase 3 copper IUD study designed?

The prospective, single-arm trial is evaluating efficacy and safety in females aged 17 to 45 years across 42 sites in the United States, with follow-up continuing beyond the current interim analysis.¹

Six-year outcomes were evaluated in 465 of 1397 participants in the evaluable-for-pregnancy population and 592 of 1601 participants in the safety population.

The presentation, “Efficacy and Safety of a Novel Hormone-Free Intrauterine Device Over 6 Years: Interim Phase 3 Study Results,” is scheduled for October 17 at 6 PM PT in the exhibit hall.

Pregnancy rates and adverse events through 6 years of use

Along with the 6-year Pearl Index, the cumulative Kaplan-Meier pregnancy rate was 3.9% (95% CI, 2.7%-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 led to study discontinuation in 139 participants (8.7%) in year 1 and in 11 participants (1.9%) in year 6.

“These interim Phase 3 results add to the clinical evidence for MIUDELLA and represent an important milestone in the ongoing study. The findings support the FDA review of the supplemental application as we work toward our ambition of expanding hormone-free contraceptive options,” said Juan Camilo Arjona Ferreira, MD, head of research and development and chief medical officer at Organon.

What did the original 3-year Miudella trials show?

Sebela developed Miudella through 3 US clinical trials that enrolled 1904 women aged 17 to 45 years. In the phase 3 efficacy cohort of women aged 17 to 35 years (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), with an overall placement success rate of approximately 99%. The most common adverse reactions (≥5%) were heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, postprocedural hemorrhage, and dyspareunia. Across all 3 studies, discontinuation due to bleeding or pain adverse reactions fell from 8.5% in year 1 to 3.2% by year 3, and expulsion rates related to discontinuation ranged from 1.9% in year 1 to 0.9% in year 3.

“Reaching 6 years of follow-up reflects the continued commitment of the participants, investigators, and study teams involved in this ongoing Phase 3 program. 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,” said Kelly Culwell, MD, chief medical officer and head of research and development at Sebela Women’s Health.

REMS training and safety requirements for Miudella

Miudella carries a boxed warning stating that improper insertion of intrauterine systems increases the risk of complications and that proper training before first use can minimize this risk. The device is available only through the Miudella REMS program. Clinicians must complete enrollment before ordering and inserting the device, and health care settings where it is dispensed or inserted must also be enrolled by an authorized representative.

Contraindications include pregnancy or suspected pregnancy; uterine abnormalities, including leiomyomas, that distort the uterine cavity; acute pelvic inflammatory disease; postpartum or postabortal endometritis in the past 3 months; known or suspected uterine or cervical malignancy; use as emergency contraception; uterine bleeding of unknown etiology; untreated acute cervicitis, vaginitis, or other lower genital tract infection; conditions associated with increased susceptibility to pelvic infections; Wilson disease; a previously placed intrauterine system that has not been removed; and hypersensitivity to device components, including polypropylene, copper, and nitinol. Patients should be counseled on the device materials and the potential for hypersensitivity before placement.

References:

1. 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. News release. Published. October 16, 2026. Accessed October 16, 2026. https://www.organon.com/news/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-an/
2. Fitch J. FDA accepts extended duration sNDA for MIUDELLA IUD. Contemporary OB/GYN. Published September 14, 2026. Accessed October 14, 2026. https://www.contemporaryobgyn.net/view/fda-accepts-extended-duration-snda-miudella-iud