The FDA has approved a hormone-free, copper intrauterine device (IUD; Miudella; Sebela Pharmaceuticals) for the prevention of pregnancy in people of reproductive potential for up to 3 years, making it the first hormone-free IUD to be FDA approved in more than 40 years, according to a press release.1
The IUD’s flexible frame, which is the smallest available in the United States, is made of nitinol, a material that has super-elastic properties, enables placement of the copper in a way that allows the device to achieve similar efficacy to copper IUDs currently approved by the FDA. This particular option uses less than half the dose of copper (175 mm2) than those previously available. This IUD does not require loading by a healthcare professional, and instead comes fully preloaded within a tapered, rounded-tip inserter with a small insertion tube diameter of approximately 3.7 mm.
Approval of this IUD follows positive data from 3 clinical trials. One of these trials, which is an ongoing prospective, multicenter, single-arm, open-label study (NCT03633799), demonstrated 3-year safety, efficacy, and tolerability data with low rates of expulsion and discontinuation. The trial will continue to assess 8-year safety, tolerability, and efficacy.
The most common adverse events observed included bleeding and pain, which are also commonly observed in both copper and hormonal IUDs, and over the 3-year duration, 15.4% of participants had to discontinue because of bleeding or pain. In other clinical trials, adverse events included heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, postprocedural hemorrhage, and dyspareunia.
“Considering it has been 4 decades since we’ve been able to offer women a new hormone-free IUD option, I find the clinical data supporting Miudella’s efficacy and safety to be very exciting,” principal investigator David K. Turok, MD, MPH, professor, Department of Obstetrics and Gynecology, University of Utah, said in a press release about the approval. “This innovative IUD may allow for improvements in discontinuation rates due to pain and bleeding and in expulsion rates. This would be very meaningful for women looking for hormone-free options.”1
Reference
- Sebela Women’s Health. FDA approves Miudella, the first hormone-free copper intrauterine system (IUS) in the U.S. in over 40 years, from Sebela Women’s Health Inc [press release]. February 25, 2025. Accessed February 26, 2025. https://sebelapharma.com/assets/media/FDA_Approval_Release.pdf