Clue, best known for its period-tracking program, has announced that it has received approval from the Food and Drug Administration for a digital birth control feature, which it said could help prevent pregnancy based on the period of onset of the period. the user. It calculates the window where someone can get pregnant based on statistical modeling.
‘It personifies over time. So, as the individual brings in his first day, we can personalize the window of their high-risk days versus their low-risk days, ” said Lynee Brayboy, Clue’s chief medical officer. TechCrunch.
The company plans to introduce its digital birth control for some time this year.
Clue says its digital birth control is 92 percent effective at preventing unwanted pregnancies when used as most people do (which makes some mistakes) and 97 percent effective when used perfectly. The statistical method it uses was originally developed and tested by researchers from the Institute for Reproductive Health at Georgetown University and a company called Cycle Technologies, and acquired in 2019 by Clue.
This is the second form of digital birth control to get FDA approval to market itself as a birth control. The first, Natural Cycles, requires users to take their body temperature every morning. The 2018 clearance was controversial – it came just after the app was blamed for unwanted pregnancies in Sweden.
Clue’s digital birth control has been approved by the FDA under its “substantially equivalent” designation, meaning the agency has determined that it is safe and effective because it is similar to a product already on the market. In this case, Clue’s product is considered similar enough to Natural Cycles. Elina Berglund, CEO of Natural Cycles, said in a statement that the company would conduct its own analysis of Clue. “Our initial findings based on the FDA submission indicate a significant difference between Natural Cycles and this other product – including that this product is based only on menstrual data and no other biomarker such as temperature,” she said.
The idea behind digital birth control is related to fertility awareness methods of birth control, where people track statistics, such as the dates of their periods, their temperature and changes to their cervical mucus to predict when they may ovulate and become pregnant. These methods can be very effective if used correctly, but they are usually strict, practically followed up. These may be good options for people who cannot or do not want to use hormonal contraceptives or other methods, but some experts are concerned that the principles may not translate into programs.
Only people who are between 18 and 45 years old and who get regular periods should use Clue’s contraceptives, the company said. TechCrunch. If someone does not qualify or if his cycle becomes too irregular, the app will exclude him, said Audrey Tsang, CEO.
Clue’s period tracker used to have a function that predicted when users were in a fertile window – the day of and days that led to ovulation. The app said that the fertile window feature should not be used as a contraceptive, but that it can help users trying to conceive. The company removed the feature last week, saying it could be inaccurate. “We have determined that it can be misleading for those who want to use the fertile window to avoid pregnancy,” reads a blog post. “We hope to provide a solution to this problem in the near future.”