FDA Approves Miudella, First Hormone-Free, Copper IUD in Over 40 Years

Key Takeaways

Miudella is the first FDA-approved hormone-free IUD in over 40 years, using a flexible nitinol frame and reduced copper dose.
Clinical trials showed Miudella's safety, efficacy, and tolerability, with low expulsion and discontinuation rates over three years.
The IUD's design, including a preloaded inserter, aims to address barriers to use and provide a hormone-free option.
Common adverse events were bleeding and pain, with a small percentage of serious adverse events, including ectopic pregnancies and uterine perforation.

The newly-approved intrauterine device (IUD) prevents pregnancy in people of reproductive potential for up to 3 years.

The FDA 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. With this approval, Miudella has become the first hormone-free IUD to be FDA-approved in over 40 years, according to a news release.¹

Image credit: Yashkin Ilya | stock.adobe.com

Miudella is a hormone-free IUD with a flexible frame made of nitinol, a material that has super-elastic properties that 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. Miudella uses the smallest hormone-free flexible IUD frame available in the US (32 mm horizontally, 30 mm vertically) with pre-cut retrieval strings. Additionally, Miudella does not require loading by a health care professional, and instead comes fully preloaded within a tapered, rounded tip inserter with a small insertion tube diameter of about 3.7 mm.^1,2

"[We are] thrilled to be able to bring this hormone-free IUD option for birth control to women in the US," Kelly Culwell, MD, head of research and development at Sebela Women's Health, said in a news release. "Our innovative copper IUD offers effective pregnancy prevention using less than half the copper of the currently available copper-based IUD in the US, utilizing a small, flexible nitinol frame. We believe these and other features of Miudella may help address barriers to use while also providing women with the hormone-free option some prefer."¹

Approval of this IUD comes after positive data from 3 clinical trials. One of these trials³, 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.^1-4The trial will continue to assess 8-year safety, tolerability, and efficacy.²

This trial enrolled participants aged 17 to 45 years (1397 aged ≤35 years at enrollment) who are at risk of pregnancy across 42 US centers. These participants were assessed through 3 years to determine if the Miudella IUD could meet the Pearl Index (pregnancies/100 person-years) as a primary efficacy outcome. Secondary outcomes included pregnancy percentages by life-table analysis, placement success, safety (frequency of adverse events [AEs]), and tolerability.^3,4

Among the total 1620 participants, the vast majority (98.8%; n = 1601) had successful IUD placements. The investigators observed a 1-year Pearl Index of about 0.94 (95% CI 0.43-1.78) and 1-year and cumulative 3-year life-table pregnancy rates of about 1.26% (95% CI 0.57%-1.95%) and 2.47% (95% CI 1.34%-3.60%), respectively. In addition, the 1- and 3-year continuation rates were approximately 78.9% and 49.6%, respectively.⁴

About the Trial

Trial Name: Evaluation of Efficacy, Safety and Tolerability of VeraCept IUD

ClinicalTrials.gov ID: NCT03633799

Sponsor: Sebela Women's Health Inc.

Completion Date (Estimated): September 22, 2027

Further, the most common AEs 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.⁴ In other clinical trials, AEs included heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, postprocedural hemorrhage, and dyspareunia.²

Additionally, IUD expulsions occurred in 36 (2.2%) and 63 (3.9%) participants over 1 and 3 years, respectively. Only 8 serious AEs occurred, of which 5 included ectopic pregnancies and the remaining 3 were uterine perforation, anemia, and uterine hemorrhage (1 occurrence each).⁴

"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," said principal investigator David K Turok, MD, MPH, professor, department of obstetrics and gynecology, University of Utah, in the news release. "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

REFERENCES

1. 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. News release. February 25, 2025. Accessed February 26, 2025. https://sebelapharma.com/assets/media/FDA_Approval_Release.pdf

2. Sebela Pharmaceuticals. MIUDELLA^® Hormone-Free Pregnancy Prevention. Accessed February 26, 2025. https://sebelapharma.com/miudella

3. Evaluation of Efficacy, Safety and Tolerability of VeraCept IUD. ClincialTrials.gov identifier: NCT03633799. Updated August 24, 2023. Accessed February 26, 2025. https://clinicaltrials.gov/study/NCT03633799

4. Creinin MD, Gawron LM, Roe AH, et al. Three-year efficacy, safety, and tolerability outcomes from a phase 3 study of a low-dose copper intrauterine device. Contraception. 2025;143:110771. doi:10.1016/j.contraception.2024.110771