Sebela Women's Health Shares Positive Phase 3 Results for New Copper IUD in Contraception

Sebela Women's Health Reports Positive Phase 3 Study Results for Innovative Copper IUD

Sebela Women's Health, a division of Sebela Pharmaceuticals, has recently made headlines with the online publication of positive results from their Phase 3 study regarding the Copper 175 mm² Intrauterine Device (IUD) in the journal "Contraception." This significant trial highlights the device's efficacy, safety, and tolerability over the first three years of its use. According to Dr. Kelly Culwell, Head of Research and Development at Sebela, these findings support the introduction of this hormone-free option for women seeking long-acting non-hormonal contraceptives.

The innovative Copper 175 mm² IUD features a flexible frame made from nitinol and contains significantly less copper than the standard 380 mm² copper IUDs currently on the market. Conducted across 42 research sites in the United States, the study was funded by Sebela Women’s Health and registered under Clinicaltrials.gov (NCT03633799). Initial findings have already been shared at key women's health conferences.

This trial stands out as it aims to explore the long-term effects of the Copper 175 mm² IUD, with ongoing evaluations set to extend up to eight years. Dr. David K. Turok, a key investigator of the study, has emphasized the device's unique design, stating, "This flexible copper IUD would be the first new hormone-free option available in 40 years."

Given the critical need for diverse contraceptive options, Turok noted, "A broad array of birth control methods should be accessible to all individuals seeking them." Many patients express a preference for non-hormonal, long-acting contraception due to various personal and medical reasons.

The Phase 3 study involved 1,620 participants aged 17-45 at risk of pregnancy. Of these, 1,601 individuals had successful IUD placements, marking a placement success rate of 98.8%. The efficacy outcomes, measured using the Pearl Index (the number of pregnancies per 100 person-years), indicated a low pregnancy rate of about 1% per year, consistent with existing copper IUDs. The one-year Pearl Index was found to be 0.94 (95% CI 0.43-1.78), while the cumulative three-year Pearl Index was 1.05 (95% CI 0.66-1.60).

Despite some initial discomfort reported by users, the data showed a considerable decrease in bleeding and pain after three months of use, a promising indicator of the device’s comfort over time. In the study, about 15.4% of participants opted to discontinue use due to bleeding or pain, while the device expulsion rates were 2.2% at one year and 3.9% at three years.

Adverse events were consistent with those reported in the usage of IUDs generally, with eight serious adverse events documented, including five cases of ectopic pregnancies. Patients and healthcare providers are drawn to long-acting reversible contraceptive methods (LARCs) like IUDs due to their high effectiveness rates, minimal contraindications, and compatibility with nearly all women.

Sebela Pharmaceuticals solidifies its reputation as an innovative player in women's health with the launch of the Copper 175 mm² IUD. Alongside this, the company is developing another next-generation hormonal IUD, further expanding the contraceptive options available in the market. Headquartered in Roswell, Georgia, with operations in Massachusetts and Dublin, Ireland, Sebela Pharmaceuticals remains at the forefront of advancing women's health initiatives.

In conclusion, the Phase 3 study results for the Copper 175 mm² IUD shed light on a transformative development for women's contraceptive choices in the U.S. healthcare landscape, promising a new era of safe, effective, and non-hormonal birth control options.