Prescriber information
for Clue Birth Control

Clue Birth Control is 92% effective with typical use and 97% effective with perfect use* (1).

Clue is at the forefront of female health and heard from users that there was a need for a new fertility awareness solution. Cycle Technologies created a product called Dynamic Optimal Timing (DOT) that used a Bayesian predictive algorithm that required only period start dates to determine which days of the cycle have a high or low risk for pregnancy. The efficacy of DOT was evaluated in a full-scale clinical trial conducted by researchers at the Institute for Reproductive Health (IRH) at Georgetown University. The trial followed 718 women in the United States of America for up to 13 cycles of use. The participants were chosen to reflect the US population of women who may be in need of contraception, including a diverse array of ages, ethnicities and relationship statuses. You can read the DOT study here. Clue Birth Control incorporates DOT’s science-based algorithm so that it can be brought to the Clue audience and beyond.

Clue Birth Control is an innovative form of contraception that uses an algorithm derived from landmark studies(1)(2)(3)(4) as well as patients’ cycle data to make personalized pregnancy risk predictions. While Clue Birth Control is a fertility awareness-based method (FABM), it has higher efficacy rates than previous studies on FABMs have shown. There is a misconception about FABMs in general because their failure rate is often quoted at 24%. This data point comes from the 1995 and 2002 National Survey of Family Growth which used retrospective surveys and then pooled data for all FABMs including the outdated “rhythm method” which is actually not a FABM as it does not require any fertility awareness. This caused a negative, long-standing propagation of the idea that FABMs are ineffective as a category of contraceptives, but the reality is that this is not the case(5).

Clue Birth Control is different from other FABMs for two primary reasons: 1) it’s an FDA-cleared, evidence-based app, and 2) it’s straightforward and easy to use. The patient is only required to enter the first day of their period and check the app for their risk prediction before they have sex that may result in pregnancy.

The patient will start with 16 high risk days for their first cycle using Clue Birth Control. Clue Birth Control uses a Bayesian statistical model to predict days with a high risk of pregnancy. The model combines the cycle length data entered by the patient with what it already knows about the distributions of cycle length means and variation in the general population(6). With consistent use, the predictions become more personalized and the number of high risk days each cycle may gradually decrease to 11-13 days.

Clue Birth Control is for women who:

• Are 18-45 years old
• Have predictable 20-40 day cycles that varied by 9 days or less over your last 12 cycles
• Have had 3 eligible cycles (4 periods) since stopping hormonal birth control or removing a copper IUD
• Have had 3 eligible cycles (4 periods) since pregnancy or breastfeeding
• Are able to track their period and check the app before they have sex that may result in pregnancy
• Will use a condom every time they have sex that may result in pregnancy on a high risk day

Clue Birth Control is an exciting opportunity to provide patients birth control that’s both hormone free and evidence-based. It will also help patients understand their menstrual cycles.

The American College of Nurse Midwives, the American College of Obstetricians and Gynecologists and the American Academy of Family Physicians each support fertility awareness based methods of contraception as effective forms of birth control.

The United States Food and Drug Administration (FDA) has classified Clue Birth Control as a software application that can be used as contraception to prevent pregnancy. Clue has been cleared to offer Clue Birth Control to patients in the United States of America after submitting extensive information about the feature’s efficacy, the clinical evidence behind it, and the processes in place to make sure the app is maintained to the safety standards of a medical device.

Indications for use:

Clue Birth Control is a software application for contraception for women 18-45 years old, to monitor their fertility and prevent pregnancy. Clue Birth Control is suitable for women with predictable cycles.

Please find the FDA device summary here. It discusses the device itself, its technical characteristics, and a comparison to the predicate device, Natural Cycles.