ROSWELL, Ga. – Jan. 24, 2025 /PRNewswire/ — Sebela Women’s Health Inc., a division of Sebela Pharmaceuticals, has announced that the journal Contraception has published positive results from the Phase 3 study of the investigational Copper 175mm2 intrauterine device (IUD). The findings suggest that this trial supports the efficacy, safety, and tolerability of the Copper 175mm2 IUD during its initial three years of use.1
Dr. Kelly Culwell, Head of Research and Development at Sebela Women’s Health, stated, “The publication of the results from our Phase 3 study in Contraception underscores the significant potential this hormone-free IUD offers for women seeking a long-acting, non-hormonal birth control option.”
The investigational Copper 175mm2 IUD features a flexible nitinol frame and has significantly less copper compared to the currently available 380mm2 copper IUDs. This Phase 3 study was conducted across 42 research sites in the United States by the Copper 175mm2 IUD Phase 3 Clinical Investigator Group and was funded by Sebela Women’s Health Inc. The ongoing research is aimed at evaluating the device’s efficacy, safety, and tolerability for up to eight years. (Clinicaltrials.gov NCT03633799).
Principal Investigator Dr. David K. Turok, MD, MPH, Professor in the Department of Obstetrics and Gynecology at the University of Utah, remarked, “This innovative, flexible copper IUD would be the first new hormone-free option introduced in 40 years, enhancing the clinician’s toolkit in the U.S. The availability of diverse birth control methods is critical, as many women prefer a long-acting, non-hormonal choice.”
Dr. Turok also noted, “The study indicated that while some users experienced bleeding and pain initially, these symptoms significantly decreased after the first three months, highlighting the tolerability of a long-acting, non-hormonal option.”
Long-acting reversible contraceptive (LARC) methods, such as IUDs and contraceptive implants, are recognized as highly effective options with minimal contraindications. According to the American College of Obstetrics and Gynecology (ACOG), the vast majority of patients are suitable candidates for these methods.2
Study Overview
This single-arm trial enlisted participants aged 17-45 at risk of pregnancy from 42 U.S. centers to receive the Copper 175mm2 IUD. Efficacy was assessed primarily among participants aged 35 years or younger at enrollment, while safety outcomes were evaluated across the entire participant group. The primary efficacy measure, the Pearl Index, calculated pregnancy occurrences per 100 person-years, covered a three-year span.
Among 1,620 enrolled participants, 1,601 (98.8%) had successful IUD placements, with 1,397 being 35 years or younger at enrollment. The pregnancy risk was approximately 1% per year, consistent with existing copper IUDs. The reported Pearl Index was 0.94 at one year (95% CI 0.43-1.78) and 1.05 at three years (95% CI 0.66-1.60). While some adverse events were observed, including bleeding and pain, these side effects tended to decrease over time. Notably, 15.4% of participants discontinued use due to bleeding or pain over the three-year period, while device expulsions occurred in approximately 2.2% at one year and 3.9% at three years. The study recorded eight serious adverse events, among which five were ectopic pregnancies and additional cases involved uterine perforation, anemia, and uterine hemorrhage.
About Sebela Pharmaceuticals Inc.
Sebela Pharmaceuticals is a prominent U.S. pharmaceutical company focusing on gastroenterology and advancing women’s health innovations. Beyond the investigational Copper 175mm2 IUD, Sebela Women’s Health is also developing another next-generation hormonal IUD for contraception that is nearing the end of clinical development. Braintree Laboratories, Inc., part of Sebela Pharmaceuticals, has been a leader in colonoscopy screening preparations for over forty years and has introduced a variety of innovative products in gastroenterology, including ongoing clinical developments like Tegoprazan for treating gastro-esophageal reflux disease (GERD) in Phase 3 trials.
Sebela Pharmaceuticals operates in Roswell, GA; Braintree, MA; and Dublin, Ireland. For further information, visit sebelapharma.com or contact 844-732-3521.
Forward-Looking Statements
This press release includes forward-looking statements regarding Sebela Women’s Health Inc., as protected under the Private Securities Litigation Reform Act. These statements are subject to risks and uncertainties that may cause actual results to differ substantially from those expressed or implied. Factors may include the development and commercialization of IUDs, competition, financing needs, regulatory approvals, and the clinical success of ongoing trials. With any pharmaceutical development endeavor, the risks associated with regulatory approval and market success remain significant. There is no assurance that any future clinical trials will be successful or lead to the commercialization of products.
References
- Creinin MD, Gawron LM, Roe AH, et al.; Copper 175mm2 IUD Phase 3 Clinical Investigator Group. Three-year efficacy, safety, and tolerability outcomes from a phase 3 study of a low-dose copper intrauterine device. Contraception. 2024 Nov 22:110771. doi: 10.1016/j.contraception.2024.110771.
- ACOG, Clinical Practice Bulletin #186, November 2017, reaffirmed 2021; Committee Statement #5, April 2023. Accessed on January 20, 2025: long-acting reversible contraception.
SOURCE: Sebela Pharmaceuticals Inc.
