RecruitingNot ApplicableNCT07630064

Flo Digital Contraceptive Study

Flo Digital Contraceptive Study: Safety and Effectiveness of Flo's Personalized Fertility Awareness Tool for Preventing Pregnancy


Sponsor

Flo Health Inc.

Enrollment

3,800 participants

Start Date

Apr 22, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if the Flo Digital Contraceptive (FDC) app can effectively prevent unintended pregnancy in women aged 18 years and older residing in the United States. The main questions it aims to answer are: What is the rate of unintended pregnancy in women aged 18-35 years using FDC as their sole method of contraception under typical-use conditions, measured using the Pearl Index? What is the cumulative probability of unintended pregnancy over 13 menstrual cycles for all participants, including those with regular and irregular cycles? Participants will: Use the Flo Digital Contraceptive app in 'prevent pregnancy' mode as their primary method of contraception for up to 13 menstrual cycles or 18 months, whichever comes first Wear an Apple Watch (Series 8 or later, or Ultra) while sleeping to collect nightly wrist temperature data, which the app uses to detect ovulation Log menstrual cycles, sexual activity, and any use of emergency contraception directly in the Flo app Complete monthly electronic surveys (ePROs) administered by the study team covering pregnancy status, adherence, safety, and experience Complete a baseline demographic survey at enrollment and an exit survey at the end of participation


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Flo Digital Contraceptive for people with contraception use. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFlo Digital Contraceptive

The Flo Digital Contraceptive (FDC) is a fertility awareness-based Software as a Medical Device (SaMD) integrated within the Flo Period \& Cycles Tracker app (iOS) in 'prevent pregnancy' mode. The FDC uses a proprietary machine-learning algorithm to classify each day of the user's menstrual cycle as either 'Not fertile' (unprotected intercourse permitted) or 'Use protection' (abstinence or barrier contraception required). Classifications are generated dynamically using menstrual cycle history and overnight wrist-skin temperature measured via Apple Watch (Series 8 or later, or Ultra), synchronized daily through Apple Health, with optional urinary LH test results as a supplementary input. Participants use FDC as their sole method of contraception for up to 13 menstrual cycles or 18 months from device activation, whichever occurs first.


Locations(1)

Lindus Health

Boston, Massachusetts, United States

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NCT07630064