Flo Digital Contraceptive for Birth Control
(FDC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Who Is on the Research Team?
Shannon Maclaughlan-David, MD, MS
Principal Investigator
Lindus Health
Are You a Good Fit for This Trial?
This trial is for women aged 18 and older in the US who want to use the Flo Digital Contraceptive app as their only birth control method. Participants must be willing to wear an Apple Watch at night, track their cycles and sexual activity in the app, and complete monthly surveys.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Enrollment and Baseline
Participants complete a baseline demographic survey and activate the Flo Digital Contraceptive device
Treatment
Participants use the Flo Digital Contraceptive app as their primary method of contraception for up to 13 menstrual cycles or 18 months
Follow-up
Participants complete an exit survey at the end of participation and are monitored for safety and effectiveness
What Are the Treatments Tested in This Trial?
Trial Overview
The study tests if the Flo Digital Contraceptive app can effectively prevent pregnancy when used alone. Women will use the app with nightly wrist temperature data from an Apple Watch for up to 13 menstrual cycles or 18 months while logging relevant health info.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Users exposed to the Flo Digital Contraceptive
Find a Clinic Near You
Who Is Running the Clinical Trial?
Flo Health Inc.
Lead Sponsor
Lindus Health
Industry Sponsor
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