FDA Approves First Birth Control App - Natural Cycles

This past Friday, the FDA approved the first smartphone app that can function as birth control. The app, Natural Cycles, utilizes an algorithm to determine days that a woman is likely to be fertile based on menstrual cycle information and daily body temperature readings. This method of contraception is called fertility awareness and is effective with diligent data input from the user.

Women using Natural Cycles must take their basal body temperature immediately after waking up in the morning, and enter this into the app. Any information pertaining to menstruation, LH testing (ovulation testing, available via Natural Cycles Webshop), or sexual intercourse is put into the app daily as well. The data recording process usually takes a few weeks of input before days of fertility can accurately be predicted.
Once the system is calibrated to a specific cycle, women are advised to enter temperature readings at least 5 times a week. Natural Cycles notes that data should not be measured on days when the user feels sick, hungover, or did not get adequate sleep.

The contraceptive app was tested in clinical trials involving 15,570 women who used the app for an average of 8 months. The researchers found that the app had a failure rate of 1.8% in “perfect users”, meaning that they only had sex on days where the app said they were not fertile. The app had a failure rate of 6.5% in women who were “typical users”, a group accounting for women who occasionally do not use the app correctly and have unprotected sex on days they are deemed fertile.

In their statement released last Friday, the FDA states, “Natural Cycles should not be used by women who have a medical condition where pregnancy would be associated with a significant risk to the mother or the fetus or those currently using birth control or hormonal treatments that inhibit ovulation.” They also noted that the contraceptive does not replace a prophylactic in disease prevention, saying “Natural Cycles does not provide protection against sexually transmitted infections.”

The basal thermometer differs from a regular thermometer in that it can measure miniscule changes in temperature, such as the half degree Fahrenheit increase around the time of ovulation. In these times of fertility, the app will present the warning message “use protection” in red. This system offers a natural means of birth control for women who prefer not to take pills or use apparatus such as an intrauterine device. The company was created by physicists Raoul Scherwitzl and Elina Berglund, a couple who was unsatisfied with available contraceptives and decided to develop a natural method.

“Natural Cycles plays a huge role in women’s lives, which humbles us. So we always have their best interest at heart in every decision we make.” – Elina Berglund, CTO & Co-founder of Natural Cycles

Sources: FDA, Natural Cycles, TechCrunch