Flo Digital Contraceptive Study
Condition(s) studied
Investigational drug(s) / intervention(s)
Flo 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.
Study 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:
1. 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?
2. 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 or SE3) 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
Primary outcome measure(s)
- Typical-Use Pearl Index in Women Aged 18-35 Years with Regular Menstrual Cycles — Up to 13 menstrual cycles or 18 months from FDC activation, whichever occurs first.
The Pearl Index (PI) is calculated as the number of unintended pregnancies per 100 woman-years of FDC exposure, assessed under typical-use conditions in women aged 18-35 years with regular menstrual cycles (21-35 days). An unintended pregnancy is defined as a documented positive pregnancy test occurring during active FDC use. Exposure time is calculated from the date of first FDC use (device activation) until confirmed pregnancy, intentional discontinuation, loss to follow-up, completion of 13 cycles, or study end, whichever occurs first. The PI is calculated with 95% exact Poisson confidence intervals. Effectiveness is concluded if the upper bound of the two-sided 95% CI is below the pre-specified clinically acceptable threshold of 10 pregnancies per 100 woman-years.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Exponent | Philadelphia | Pennsylvania |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07630064 on ClinicalTrials.gov ↗ ← All trials in the USA