Positive Data from Phase 3 Study of a New Copper IUD

Sebela Women's Health Inc. recently announced positive data from a pivotal Phase 3 study of their investigational Copper 175 mm² IUD. The study showed that bleeding and pain significantly decreased after the first three months, with low discontinuation rates due to adverse events over three years. The risk of pelvic infection was low, regardless of past medical history. This next-generation, hormone-free IUD, which has a flexible nitinol frame, aims to provide a highly effective, long-acting option for women seeking hormone-free contraception. 

"Sebela Women's Health remains encouraged by the additional analysis of the pivotal Phase 3 trial for what would be the first hormone-free IUD coming to market in almost 40 years." said Kelly Culwell, MD, Head of Research and Development at Sebela Women's Health. "In a study conducted by the non-profit group, HealthyWomen, 60% of the more than 5,000 respondents indicated they preferred a birth control without hormones, and effectiveness was the most important factor to both patients and their practitioners.” Read more from PR Newswire.