FDA approves 1st direct-to-consumer birth control application
The FDA approved marketing for Natural Cycles, a mobile medical application that claims to help prevent pregnancy.
Natural Cycles is the first pregnancy prevention application to be approved by the FDA, though the organization urges women to use caution when utilizing the application because no method of birth control is 100 percent effective.
The application, intended for pre-menopausal women aged 18 and older, uses an algorithm that calculates the days of the month a woman is likely to be fertile based on basal body temperature readings and menstrual cycle information. Natural Cycles requires women to take their temperature when waking up and enter it into the application.
In clinical studies involving more than 15,500 women, the application had a perfect use failure rate of 1.8 percent, indicating that if women used the method exactly as directed, only two in 100 women would get pregnant over the course of a year. The typical use failure rate was 6.5 percent, indicating that seven of 100 women who sometimes did not use the application as directed would get pregnant.
"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, MD, PhD, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, in a prepared statement. "But women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device."
As a senior news writer for TriMed, Subrata covers cardiology, clinical innovation and healthcare business. She has a master’s degree in communication management and 12 years of experience in journalism and public relations.