New Birth Control Injects Hundreds of Microneedles to Prevent Pregnancy

“There is a remarkably high rate of unintended pregnancies around the world.”

In the world of birth control, the gold standard of contraception incorporates two key elements: It should be long-lasting like an IUD, and it should be self-administered like a pill. Ideally, it would have both traits, but a contraceptive that meets these standards isn’t available yet. Steps detailed Monday in Nature Biomedical Engineering, however, suggest it soon could be.

The study authors want to create a long-lasting, self-administered type of birth control because what’s available isn’t working as well as public health officials wish it was. In the new paper, the authors point out that, despite advances in contraceptive methods, 40 percent of all pregnancies worldwide in 2012 were unintended. Non-hormonal contraceptive methods like condoms are often used incorrectly, and long-acting contraception like a birth control implant requires time and access to a healthcare professional.

“There is a remarkably high rate of unintended pregnancies around the world, and part of the reason for that is inadequate access to appropriate contraceptive options,” study co-author Mark Prausnitz, Ph.D., tells Inverse. “We think that we have been able to bridge the gap between a contraceptive that can last a long time and that people can administer themselves.”

Prausnitz and his team had previously worked with scientists from Emory University on a trial in which human patients received an influenza vaccine through a microneedle patch. That trial went well, Prausnitz explains, so “the solution we came up with is a microneedle patch contraception, where you can deposit into your skin microneedles that release a contraceptive hormone over the course of the month.”

contraception patch
A simulated application of the microneedle contraception patch.

It’s not as intense as it sounds: A patient simply presses the patch onto their skin, and very, very small microneedles enter the skin’s superficial layer. The team built a little bubble into the interface between the microneedles and the patch’s backing, so as one passes their thumb over the patch and applies force, the tiny needles snap off within five seconds of patch administration. Once the microneedles are embedded, they slowly biodegrade. While that happens, the birth control drug levonorgestrel is released.

By the end of the roughly one-month study period, all of the levonorgestrel had come out of the microneedles, and the needles had completely biodegraded and disappeared.

In previous studies, like the ones that used microneedle patches to deliver an influenza vaccine, study participants said the process didn’t bother them.

“Some people describe it as if you were to take a bit of Velcro and press that against your skin,” Prausnitz explains. “You feel a sort of roughness being pushed against your skin — there would be that sensation there — but people don’t describe it as painful.”

microneedle patch
Professor Prausnitz, left, and post-doctoral research scholar Wei Li, right, examine an experimental microneedle patch. 

What sets this birth control device apart is that microneedles sit under the surface of a person’s skin for a month — instead of for just a moment. The expectation is that the process should be well tolerated by people’s skin, but this idea needs to be explored further. So far, these birth control microneedle patches have only been tested on rats, but those trials, detailed in the new study, were successful: The patches left little visible evidence of use, and the rats maintained plasma concentrations of the hormone above the human therapeutic level for one month.

The drug used in the study, levonorgestrel, is a well-established contraceptive hormone. It’s incorporated into IUDs, and it’s the active ingredient in Plan B. As a result, Prausnitz says that “we know that it’s safe, it works, and we know that we need to maintain a certain concentration level of it in the bloodstream of a woman, in order for the patch to be an effective contraception.” Since the team was able to establish that concentration in the bloodstream of rats, it’s a good sign that this concentration level would stick around when the patch is eventually given to a human.

It remains unclear when the patch will actually be given to humans. The researchers hope they can start a clinical trial within two years. Prausnitz says that they’re doing the work to prepare for human trials, but are in need of time and funding.

If this sort of patch is developed, and it’s proven to be safe and effective, Veronika Mesheriakova, M.D., thinks it “could have great potential.” Mesheriakova, an assistant professor at the University of California, San Francisco, whose research focuses on contraception use among adolescents, was not a part of this study.

birth control
Contraception that isn't designed to be used daily is thought to be more effective in the long-term.

She tells Inverse that, as an adolescent medicine physician, she frequently recommends longer-acting, reversible contraceptives like IUDs and contraceptive implants to her patients, as they are “very effective, low maintenance, have acceptable side effect profiles, and have been recommended as the number 1 choice for adolescents by professional organizations such as the Society of Adolescent Health and Medicine and the American College of Obstetricians and Gynecologists.”

Mesheriakova says that while older adolescents and young adults frequently opt for IUDs, young teens in her practice tend to favor the contraceptive implant Nexplanon. Teenagers are more comfortable with the idea of something being inserted into the skin of their arms than into their uterus, she says. But the implant still requires an uncomfortable injection, and a patient could be left with a small scar. She says that if there was an equally effective, long-acting contraceptive that a patient could apply painlessly on her own, she thinks it would quickly become a top choice in her practice.

“In fact, just last week I saw a very sweet adolescent girl who came to my clinic intending to get a contraceptive implant, but due to her severe needle phobia, wasn’t able to move forward with the procedure,” Mesheriakova says. “I think she would have been much happier if I could have offered her a painless, microneedle patch!”

And while this patch was designed with women in developing countries in mind, it’s fair to say that it would be helpful for women living in any space where birth control is hard to come by. Recent news suggests that the United States could be one of those places. On Monday, U.S. District Judge Wendy Beetlestone in Philadelphia imposed a nationwide injunction blocking the Trump administration from implementing a ruling that would allow employers to decline to offer contraception coverage. Currently, the Affordable Care Act requires most companies to offer health insurance that covers FDA-approved birth control at no cost.

President Donald Trump has repeatedly attempted to dismantle that ruling; his administration argues that the mandate imposes a burden on the exercise of religion by certain employers. If he succeeds, it will change the lives of many American women: According to Judge Beetlestone, knocking down the ACA mandate would cause 705,000 women to lose coverage. In that case, women in America will need a long-lasting solution that they can administer themselves.