For more than four decades, women have had only one option for non-hormonal copper intrauterine device (IUD) birth control, the Paragard. But thanks to a new clinical trial, a portion of which was conducted by Indiana University School of Medicine physician scientists, a second option will soon be available.
The Miudella, approved in February 2025 by the U.S. Food and Drug Administration and named a Time Magazine "best invention" for 2025, is a more flexible IUD that uses a smaller insertion device and less copper, which results in fewer side effects. Thirty-two women participated in the trial though IU. Miudella parent company Sebella Pharmaceuticals expects to make the product widely available later this year.
"Indiana University does a lot of reproductive health research, and we had a great infrastructure ready and available for trials like this one," said Caitlin Bernard, MD, principal investigator for the IU site.
IU was one of several dozen sites for the third phase of the clinical trial, which was led by David Turok, MD, of the University of Utah.
Bernard, a practicing obstetrician-gynecologist and an assistant professor within the discipline at IU School of Medicine, said she gladly volunteered to assist with a possible breakthrough in women’s health — an area she said is underfunded and under-researched.
"Women's health makes up less than 1% of National Institutes of Health funding, and contraceptive research is even less prioritized by both government and industry-funded studies," Bernard said.
Bernard was joined on the trial by her frequent collaborator and fellow assistant professor within the Department of Clinical Obstetrics and Gynecology, Amy Caldwell, MD, as well as IU Health nurse practitioner and certified nurse-midwife Rebecca Evans.
Currently, only one non-hormonal copper IUD is offered to patients. It was first approved in 1984, and little progress has been made by way of innovation. Some women experience heavy, painful periods while using this method.
Miudella's ability to reduce these effects has been proven through the trial, Bernard said. It was also proven effective in preventing pregnancy for up to three years, with the current trial designed to prove effectiveness through eight years.
"My career has always been about improving access to reproductive healthcare for women, particularly in the Midwest and especially during times of restrictions on access," Bernard said. "This research was a great opportunity to improve women’s ability to control their own health and to have options that best fit them and their families."
