FDA's decision was based on a large body of clinical data from 15,570 women, in which Natural Cycles was shown to be 93 percent effective with typical use*.1
"We are aware of a significant number of women in the US looking for alternative, effective natural methods of birth control," said Juan Acuna, M.D., Associate Professor of OBGYN, Department Chair at Florida International University College of Medicine. "Natural Cycles provides physicians with this much-needed natural and effective option to offer to appropriate patients."
The "brain" behind Natural Cycles is a smart algorithm that can accurately determine a woman's daily fertility by analyzing changes in her basal body temperature, which increases after ovulation. To use Natural Cycles, women are required to take their temperature with a basal thermometer first thing in the morning and enter the information into the app. The algorithm uses this information to detect ovulation, thereby identifying "green" days, when no protection is needed, or "red" days, when protection is required or the user should abstain from sex. The algorithm has been intricately designed to account for sperm survival, variation in cycle length, ovulation day, temperature fluctuations and the length of the follicular and luteal phases of the menstrual cycle.
"Based on the strength of our clinical data, we are delighted that the FDA granted De Novo classification for Natural Cycles and look forward to working together with healthcare professionals to offer a digital form of birth control to women in the US," said Elina Berglund, Ph.D., CTO and co-founder, Natural Cycles. "Our mission at Natural Cycles is to pioneer women's health with research and passion, and this milestone marks a very important step in that journey."
Natural Cycles may be suitable for women who are looking for a natural method of contraception and have a lifestyle that enables them to take their temperature first thing most mornings. Only barrier methods of contraception, such as condoms, protect against sexually transmitted infections (STIs). For those women who are ready to start a family, Natural Cycles can also be used to help plan a pregnancy by identifying their most fertile days.
Natural Cycles is the only app CE marked for birth control in Europe and has more than 900,000 registered users worldwide.
*Typical use effectiveness accounts for all possible reasons for becoming pregnant while using the app, from having unprotected sex on a red day to the app wrongly attributing a green day or the chosen method of contraception on a red day having failed.
1 Berglund E, Scherwitzl R, et al. Contraception. 2017;96(6):420–425