09 March 2021

Digital contraceptive

In the US, fully digital contraception is allowed

Oleg Lischuk, N+1

U.S. Food and Drug Administration (FDA) approved the use of a fully digital method of contraception. The Clue Birth Control application of the German company BioWink requires you to enter only the dates of the beginning of menstruation, after which it determines the "safe" days.

The available barrier and pharmacological contraceptives have a high (more than 90 percent) effectiveness. However, their use is not always possible for various reasons, such as contraindications, low availability, physical and mental discomfort, and others. Independent calculation of "safe" days (in which the probability of conception tends to zero) by keeping a diary of menstrual cycles, often with temperature measurement and evaluation of cervical mucus, is inconvenient and does not provide reliable protection.

Modern developers propose to use digital technologies for these purposes and have brought the idea to practical application. In 2018, the FDA registered the first "digital contraceptive" – the application of the Swedish company Natural Cycles. However, it requires additional instrumental temperature measurements. In addition, there were complaints from users about the lack of reliability of the method.

Clue Birth Control is conceived as a paid extension of the existing application for monitoring the menstrual cycle. For the new functionality, BioWink in 2019 acquired the Dynamic Optimal Timing (Dot) algorithm, developed and successfully tested by Georgetown University and Cycle Technologies. It requires only the regular introduction of the date of the first day of menstruation and calculates the individual characteristics of the cycle using Bayesian modeling, indicating intervals with high and low risk of getting pregnant with unprotected sexual intercourse.

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According to the medical director of Clue, Lynae Brayboy, as the application is used, the results become more personalized, which reduces the "unsafe" interval from 16 to about 11 days. The efficiency claimed by the company ranges from 92 percent with "typical" use, typical for most people, to 97 percent with "ideal" use. Competing Natural Cycles promises 93 percent efficiency, which is comparable to oral hormonal contraception.

Based on the results of clinical trials, the FDA approved the use of Clue Birth Control in women aged 18 to 45 years with relatively regular menstruation. Registration in the application is preceded by a detailed survey on this topic. The algorithm will block users who are not in the specified age group, or with a markedly unstable cycle, said Audrey Tsang, executive director of the company.

The start of sales of Clue Birth Control in the USA is scheduled for 2021, the next sales market should be European countries. The price of the application has not yet been disclosed.

The improvement of contraceptive methods is carried out in different directions, giving them additional functions, increasing reliability and ease of use. So, hormonal drugs have been created for women, which can be taken once a month or embedded in jewelry. Oral contraceptives, various topical gels and "smart" condoms have been developed for men.

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