JERSEY CITY, N.J., October 16, 2026
Organon (NYSE: OGN), a global healthcare company focused on women’s health and general medicines, announced positive interim results through six years of use from an ongoing Phase 3 study evaluating MIUDELLA®, a hormone-free, copper intrauterine device (IUD). The findings will be presented by Sebela Women’s Health at the 2026 Society of Family Planning (SFP) Annual Meeting, taking place October 17–19 in San Francisco, California. The six-year analysis showed a cumulative Pearl Index of 0.93 and a cumulative Kaplan-Meier pregnancy rate of 3.9%. No new safety signals were identified during the additional three years of extended use. Organon obtained exclusive global licensing rights to MIUDELLA from Sebela Women’s Health in June 2026. Follow-up in the Phase 3 study remains ongoing, while the U.S. Food and Drug Administration (FDA) reviews a supplemental application seeking an extended duration of use of up to six years.
Six-Year Data Assess Contraceptive Efficacy and Safety
The prospective, single-arm Phase 3 study is being conducted across 42 sites in the United States and evaluates the efficacy and safety of MIUDELLA in females aged 17 to 45 years. The interim six-year analysis included 465 participants in the evaluable-for-pregnancy population and 592 participants in the safety population, from the respective enrolled populations of 1,397 and 1,601 participants. The cumulative six-year Pearl Index was 0.93 (95% confidence interval [CI], 0.62–1.34), while the cumulative Kaplan-Meier pregnancy rate was 3.9% (95% CI, 2.7%–5.8%). Treatment-emergent adverse events reported through six years included heavy menstrual bleeding, painful menstruation and pelvic discomfort. Bleeding- and pain-related adverse events leading to study discontinuation were reported in 139 participants (8.7%) in year one and 11 participants (1.9%) in year six. These interim findings add longer-term observations to the clinical evidence for MIUDELLA, although continued follow-up is needed to complete the study.
FDA Reviews Application for Extended Duration of Use
MIUDELLA is currently indicated in the United States for pregnancy prevention in females of reproductive potential for up to three years. The FDA has accepted for review a supplemental New Drug Application (sNDA) seeking to extend the approved duration of use to six years, with a Prescription Drug User Fee Act (PDUFA) action expected in the second quarter of 2027. The proposed extension is supported by the ongoing Phase 3 study’s long-term efficacy and safety assessment. Organon’s Head of Research and Development and Chief Medical Officer, Juan Camilo Arjona Ferreira, MD, said the interim findings contribute to the clinical evidence supporting the supplemental application and the company’s efforts to expand hormone-free contraceptive options. Kelly Culwell, MD, Chief Medical Officer and Head of Research and Development at Sebela Women’s Health, highlighted the contribution of study participants, investigators and clinical teams to achieving six years of follow-up. The FDA has not yet approved the requested six-year duration; the currently approved indication remains three years.
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Hormone-Free Contraception and Important Safety Requirements
MIUDELLA is a low-dose, copper-containing intrauterine system developed by Sebela Women’s Health and licensed globally to Organon. Its hormone-free design offers an alternative to hormonal contraception, but use requires attention to the product’s safety requirements. MIUDELLA carries a Boxed Warning concerning complications from improper insertion and is available only through a restricted Risk Evaluation and Mitigation Strategy (REMS) program. Healthcare providers must enroll and complete required insertion training before first use, and healthcare settings dispensing or inserting the device must also meet the program’s certification requirements. Potential complications include uterine perforation, infection, abnormal bleeding, pregnancy loss if pregnancy occurs with the device in place, and expulsion. The product is contraindicated in several circumstances, including pregnancy or suspected pregnancy, certain uterine abnormalities, active pelvic infections and Wilson’s disease. Common adverse reactions observed in clinical trials include heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort and pelvic pain. Organon’s portfolio includes more than 70 products across women’s health and general medicines, serving markets in more than 140 countries. The ongoing MIUDELLA study and regulatory review are part of the company’s efforts to expand access to contraceptive options.
Source:::Organon,press release
