Clue, a Berlin-based femtech company, announced today that it has received FDA clearance to launch Clue Birth Control, an all-digital form of contraceptive that relies on period tracking data.

By combining user menstrual cycle data with Clue’s predictive algorithm, the birth control feature can show which days are high or low risk for pregnancy. From there, users can modify their behaviors to accommodate their risk level. On high-risk days, Clue suggests that users either abstain from sex altogether or use another form of contraception, such as condoms.

As use progresses, the algorithm learns more about each member's cycle and makes more personalized predictions that could lead the high-risk window to shrink over time.

Clue’s birth control algorithm is based on the Dynamic Optimal Timing (DOT) algorithm, which it acquired and implemented into its birth control feature. In a yearlong clinical trial of more than 700 women, the algorithm proved to be 92% effective with typical use and 97% effective with perfect use at preventing pregnancy.

The digital birth control product will be available later this year as a feature within the Clue app for users based in the United States, according to the announcement.

Before Clue users can access the birth control feature, they must complete an in-app onboarding process to determine their eligibility. Users must be between 18 and 45 years old, can track their period and check the app each day they have sex, will use protection on high-risk days, have regular cycles that are 20 to 40 days, and have had four periods since stopping hormonal birth control or being pregnant.

In addition to the announcement of its digital birth control offering, the company shared some movements within its leadership team. Ida Tin, Clue’s founder, has become the board’s chairwoman, and Audrey Tsang and Carrie Walter will now act as co-CEOs.

WHY IT MATTERS

Clue’s birth control app differs from others on the market in that it doesn’t require users to track anything other than their period start dates.

In comparison, the Natural Cycles app, which received FDA clearance in 2018, identifies a user’s daily fertility status based on their basal body temperature and other menstrual data.

“As a leader within this field, we feel it’s our responsibility to uphold the highest standards and after our initial findings based on the FDA filing indicate a significant difference between Natural Cycles and this other product – including that this product is solely based on menstrual data and no other biomarker such as temperature – our medical and research teams will be doing an independent analysis,” Elina Berglund, cofounder and CEO of Natural Cycles, said in a statement.

Based on Natural Cycles’ initial analyses, its app is slightly more effective than the Clue app, can confirm ovulation and works with irregular period cycles.

In response, Clue reassured that its birth control app was deemed safe and effective for its intended user population. 

"An abbreviated 510K is no less rigorous than a 'De Novo' application, which is the FDA clearance process for the first product in any category of medical device," a Clue spokesperson told MobiHealthNews in a statement. "Because the category of software application for contraception is already recognized by the FDA, Clue Birth Control and any future contraceptive app that raises similar regulatory questions will be assessed through the standard process for a recognized category, known as a 510K. Clue Birth Control’s clinical trial, app development process, and resulting safety and efficacy claims were evaluated thoroughly by the FDA.

"The clinical trial underlying Clue Birth Control was conducted by researchers at Georgetown University using best practices of clinical research and published in a peer-reviewed publication. Clue has distinguished itself by being evidence-based and employing scientific rigor in all that we do. We are committed to transparency and we invite physician-scientists and contraceptive researchers to collaborate with us and to conduct their own independent studies."

THE LARGER TREND

When MobiHealthNews spoke with Clue’s chief medical officer, Dr. Lynae Brayboy, last summer, she said the company was looking to create digital tools for the entire lifespan of women.

“I think the beauty of the field of obstetrics and gynecology is that you take care of girls all the way to women,” she said at the time. “I think that hopefully in our future we’ll be doing that very same thing and be providing services to young adolescent women as they are making the pubertal transition all the way to women in menopause, which I think is really exciting and hopefully is on the horizon for us.”

Natural Cycles recently submitted a 510(k) Premarket Notification to the FDA to revise its labeling to include temperature monitoring wearables that could be used with the app instead of basal thermometers.

ON THE RECORD

“We could see that the contraceptive options out there simply weren’t good enough,” Tin said in a statement. “We wanted to utilize our strengths in cycle science and data science to upgrade traditional fertility awareness-based contraceptive methods and create a smart version, easy to use, powered by the technology in our pockets. We wanted a trustworthy and reliable alternative for women, one that is based on their own personal data, effective, has no side effects, and is hormone-free. We’re excited that we have FDA clearance for Clue Birth Control, an innovation in natural pregnancy prevention which we believe will prove a better and more convenient method for many people’s needs and lifestyles.”