The University of Chicago Medical Center is currently one of 16 sites participating in a clinical trial, run by nonprofit pharmaceutical company Medicines 360, being conducted to put another IUD on the market.
IUDs, or intrauterine devices, are small, plastic, t-shaped devices that are inserted into the uterus to prevent pregnancy. According to a study published in May by the New England Journal of Medicine, IUDs can be up to 20 times more effective in preventing pregnancy than oral contraceptives, such as the pill. Additionally, unlike the pill, which must be taken each day, IUDs once inserted can last from five to 12 years, according to Planned Parenthood.
That effectiveness and convenience comes with a more expensive price tag. One of the two IUDs currently available in the United States, Mirena, a hormonal IUD, costs $843.60 without insurance, according to the Mirena website.
“[Mirena is] incredibly expensive, even for people with insurance, which makes it very cost-prohibitive for a very ideal segment of IUD users—young women,” said Stephanie Mistretta, senior clinical researcher in the Department of OB-GYN at the University of Chicago hospital. The trial was conducted on women ages 16-35, the target consumers.
Medicines 360, a San Fransisco-based company, is looking to change that by creating an IUD that, except for the type of plastic and inserter, is functionally identical to Mirena, only without the cost barrier. “They have developed essentially the same thing and believe they’re going to be able to market it for less than a quarter of the cost,” Mistretta said.
So far, the U of C branch of the study has enrolled approximately 30 women for the six-year trial. Although many participants are associated with the University, they have also recruited via ads on the CTA and thus have a very diverse group of women, Mistretta said.
“For the most part people have been very excited to enroll, especially given long-term stabilization of this method,” Mistretta said. “You don’t have to go get refills, you don’t have to show up to a pharmacy....all of the costs are covered by the trial. Nothing is ever billed to insurance so it is a nice way to get some additional free health care.”
One U of C student, however, opted to back out after hearing about the side effects.
“It just seemed like I was making a very big decision in a very small amount of time without really any thought to long-term consequences. Everyone agreed that it was convenient and that it was nice not to have to worry about taking the pill every day, but a lot of people said they were having weird health problems,” she said.
With any type of birth control—hormonal or not—side effects are to be expected. But according to Mistretta, the differences between the hormone profiles of the IUD and an oral contraceptive cause different side effects. The IUD may induce breast swelling or tenderness, mood-swings, or an increase or decrease in acne.
Melissa Gilliam, M.D., professor of OB-GYN, and section chief of Family Planning at the University of Chicago Hospital, is the trial’s principal investigator at the U of C site. “[The new IUD] may still not be right for everyone, but those choices should be made on good information. No method is one-size-fits-all but we do want to cut through non science-based information,” she said.
IUDs provide no protection against sexually transmitted infections or diseases. One of the requirements of the clinical trial is that every participant has been in a mutually monogamous relationships for at least six months because, Mistretta said, they ask that participants use no other forms of birth control in the duration of the trial, including condoms.
Second-year Samantha Karas, who is not enrolled in the clinical trial, bought the Mirena IUD for $150 in January from Planned Parenthood, which provides birth control at a discounted price.
“When you’re a college student, that’s a pretty significant chunk of money,” she said. “But then that pays for itself in like a year and three months. If you’re going to have it for four years, it’s really cost-effective.”
If successful, the Medicines 360 clinical trial will provide another inexpensive way for all women to utilize IUDs.
Karas’s enthusiastic endorsement of the IUD represents a shift in the national attitude towards that particular form of birth control, especially in younger women.
“I would say most of our participants in this trial are age 26 and under,” Mistretta said. “So it’s definitely more in the social consciousness of younger women.”