Clue, best known for its menstruation tracking app, announced that it has received authorization from the Food and Drug Administration for a digital birth control function, which it says can help users prevent pregnancy based on the date of birth alone. onset of menstruation. It calculates the window in which someone can get pregnant based on statistical modeling.
“Customizes over time. So, as the individual puts on his first day of the cycle, we are able to customize the window of his high-risk days in relation to the low-risk days, ”said Lynae Brayboy, chief physician at Clue TechCrunch.
The company plans to launch its digital birth control sometime this year.
Clue says her digital birth control is 92 percent effective in preventing unwanted pregnancies when used in the way that most people do (accounting for some mistakes) and 97 percent effective under perfect use. The statistical method he uses was originally developed and tested by researchers at the Institute for Reproductive Health at Georgetown University and a company called Cycle Technologies, and acquired by Clue in 2019.
This is the second form of digital birth control to obtain authorization from the FDA to market itself as birth control. The first, Natural Cycles, requires users to take body temperature every morning. Its release in 2018 was controversial – it came shortly after the app was accused of unwanted pregnancies in Sweden.
Clue’s digital birth control was approved by the FDA under its designation “substantially equivalent”, meaning that the agency determined it to be safe and effective because it is similar to a product already on the market. In this case, Clue’s product was considered quite similar to Natural Cycles. Elina Berglund, CEO of Natural Cycles, said in a statement that the company will do its own analysis of Clue. “Our initial findings based on FDA documents indicate a significant difference between Natural Cycles and this other product – including that this product is based solely on menstrual data and no other biomarkers, such as temperature,” she said.
The idea behind digital birth control is related to fertility awareness birth control methods, where people track metrics such as the dates of their periods, their temperature and changes in cervical mucus to predict when they are ovulating and may become pregnant. These methods can be highly effective when used correctly, but they usually require practical and rigorous tracking. They may be good options for people who cannot or do not want to use hormonal contraceptives or other methods, but some experts fear that the principles cannot be translated into applications.
Only people between 18 and 45 who have regular periods should use Clue’s birth control, the company said TechCrunch. If someone is ineligible or their cycle becomes too irregular, the app will block them, said CEO Audrey Tsang.
Previously, Clue’s menstruation tracker had a feature that predicted whether users were in a fertile window – the day and days leading up to ovulation. The app states that the fertile window feature should not be used as a birth control, but it can help users who are trying to conceive. The company removed this feature last week, saying it could be inaccurate. “We have determined that this can be misleading for those who wish to use the fertile window to prevent pregnancy,” he said in a blog. “We hope to offer a solution to this problem in the near future.”