- The Washington Times - Friday, August 10, 2018

In a first, the Food and Drug Administration has said it will let a Swedish company market a mobile application that can be used as a form of contraception.

Dubbed “Natural Cycles,” the smartphone app calculates when a woman is likely to be fertile by using daily temperature readings and menstrual cycle information.

Women who want to rely on the app must take their temperature upon waking each day and enter the reading into the app.

The FDA said women must use a basal thermometer, which is more sensitive than regular thermometers to slight changes in temperature at ovulation.

Users should avoid sex on days the app reads “fertile day,” or use another form of contraception on those days, which will typically occur four or five times a month, the agency said Friday.

“Consumers are increasingly using digital health technologies to inform their everyday health decisions, and this new app can provide an effective method of contraception if it’s used carefully and correctly,” said Terri Cornelison, assistant director for women’s health at the FDA’s Center for Devices and Radiological Health.

Centuries of archival records show that women often recorded the days they had sexual intercourse and the dates of their periods in calendars or diaries, especially before reliable physical or hormonal contraception became legal or accessible, according to Lauren MacIvor Thompson, a visiting professor at Georgia State University who studies women’s health.

Mobile “period tracker” apps “are just a new technological framework for doing the same thing that women have always done to track fertility,” she said.

For its part, the maker of Natural Cycles said it was “delighted” that federal regulators had green-lighted the promotion of its product.

“This decision enables us to commercialize in the United States as a key step in our global strategy,” company co-founder Elina Berglund said.

Ms. Thompson said the FDA’s blessing seems in keeping with the Trump administration’s general emphasis on natural family planning over medical birth control, though there may be risks.

“If clinics or physicians emphasize the use of the Natural Cycles apps to their patients over other reliable and medically approved forms of hormonal or physical contraception, that could result in more unintended pregnancies,” she said. “Like women in the past who had to rely on their memory and consistency in recording various aspects of their cycles, this app will require users to be very consistent in taking their temperature and recording the information.”

The FDA said Natural Cycles had 1.8 percent failure rate among women who used it perfectly in clinical studies involving 15,570 women, meaning 1.8 in 100 users will become pregnant by having sexual intercourse on a day when the app claimed they were not fertile, or because another contraception method failed on a day when the app said they would be fertile.

It had a “typical use” failure rate of 6.5 per 100, which accounted for women not using the app correctly at all times or having unprotect sex on fertile days.

“Women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device,” said Dr. Cornelison of the FDA.

The company says its product is best for women aged 20 to 40 who are comfortable using condoms on their fertility days.

“Hormonal contraception affects your cycle and temperature, so you cannot start using Natural Cycles until you have come off it,” its website says.


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