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cleared

Prescriber information
for Clue Birth Control

Top things to know

Clue Birth Control is a FDA-cleared evidence-based fertility awareness-based method (FABM) that uses a validated algorithm to provide personalized pregnancy risk predictions.

Clue Birth Control is 92% effective at preventing pregnancy when used typically and 97% effective when used perfectly.*

Clue Birth Control is for women who are 18-45 years old with cycles that are 20 to 40 days long and varied by 9 days or less over the last 12 cycles.

If the patient has recently been pregnant or on hormonal birth control or has used a copper IUD, they should wait until they have had at least 3 eligible cycles (4 periods) before using Clue Birth Control.

Clue Birth Control requires the patient to log in and document cycle day 1 (period start date) and check their risk each day before they have sex.

Clue Birth Control is an over-the-counter product. The feature evaluates your patient’s eligibility and provides all education required for safe use. We encourage our users to speak with their healthcare provider before choosing their desired birth control method.

*In the interest of providing easy-to-understand information that empowers people to make informed health decisions, when reporting efficacy figures, Clue uses the upper bound of the failure rate’s 95% confidence interval. Clinical trial results represent an estimate of the population efficacy rate. To be conservative, Clue reports the upper bound of the confidence interval from the peer-reviewed, published clinical trial of Clue Birth Control rather than the point estimate.The clinical trial found a point estimate with confidence intervals for the typical-use failure rate of 5.8% (95% confidence interval: 3.6% - 8.1%). The point estimate with confidence intervals for perfect use failure rate was 1.0% (95% confidence interval: -0.9% - 2.9%). Therefore, the marketed efficacy rates are 92% effective with typical use and 97% effective with perfect use. The Clue Birth Control clinical trial was conducted by researchers at Georgetown University in Washington, DC, and is registered at ClinicalTrials.gov as study number NCT02833922.

Introducing

Clue Birth Control

Clue Mobile App with Clue Birth Control interface displayed

Clue Birth Control is our FDA-cleared digital contraceptive, built right into the Clue app, which your patients already trust and use to track their periods and other cycle-related symptoms.

Clue Birth Control is a technology-enhanced fertility awareness-based method (FABM) that uses a patient’s cycle data to predict high and low risk days for pregnancy. On high risk days, the patient must use condoms every time they have sex that may result in pregnancy.

Clue Mobile App with Clue Birth Control interface displayed
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Efficacy

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Evidence

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How it works

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Eligibility

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Charting a visit

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The importance of FDA clearance

A word from our CMO

The creation of Clue Birth Control (CBC) came out of the tremendous need for a reliable, on-demand birth control option without the side effects.

Hormonal birth control has done wonders to improve the lives of people with periods worldwide and we are supportive of those who benefit from it. Users of hormonal birth control have many choices, but researchers have found that even with free accessible hormonal contraceptives, many individuals switch or discontinue hormonal birth control because of side effects1. This leaves many people with periods at risk for unintended pregnancy where in the United States approximately 42-69% of pregnancies are unintended2.

Therefore, we’ve created Clue Birth Control as a convenient alternative for people with periods to take control of their contraception without side effects.

an image of Clue's CMO, Lynae Braeborne

Lynae Brayboy, MD, FACOG Clue's Chief Medical Officer

Therefore, we’ve created Clue Birth Control as a convenient alternative for people with periods to take control of their contraception without side effects.

Clue Birth Control is NOT the rhythm method. It’s a digital fertility awareness-based method that utilizes Bayesian modeling to predict ovulation based on cycle length3. It provides personalized predictive pregnancy prevention for your patients with regular periods who are not candidates for hormonal birth control or prefer not to take it. Our digital contraceptive helps the modern patient understand her/their cycle which is a vital sign for overall health.

Clue Birth Control is designed for contraception, and has been tested in a rigorous clinical trial for that purpose. In order to obtain FDA clearance to offer this feature, the US regulator examined not just the clinical trial, but subjected the entire app as well as software development processes to extensive scrutiny. Clue had to satisfy them that it's science is sound, and that its way of working, including on user privacy, is up to the standards expected of a medical device manufacturer.

an image of Clue's CMO, Lynae Braeborne

Lynae Brayboy, MD, FACOG Clue's Chief Medical Officer

About Clue

Clue is a period tracking app that uses data and science to help your patients understand their bodies better. The website helloclue.com/articles also offers your patients an encyclopedia of science-based articles on menstrual and reproductive health, written by Clue's in-house team of clinicians.

Learn more about the Clue app here.

  • Download the Clue app on the App Store
  • Download the Clue app on the Play Store
An illustration of the Clue app