Flo Digital Contraceptive Study (NCT07630064) | Clinical Trial Compass
RecruitingNot Applicable
Flo Digital Contraceptive Study
United States3,800 participantsStarted 2026-04-22
Plain-language 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
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults with female reproductive organs aged ≥18 years
* Reside in the United States of America
* Have menstrual frequency (i.e., interval between first day of bleeding each cycle) between 16-90 days
* Sexually active, having vaginal sex with male partner(s) without known fertility problems AND where neither partner has a known, or is at high risk of, sexually transmitted infections (STIs).
* Desiring contraception, i.e., planning to prevent pregnancy and not currently trying or planning to conceive for at least 12 months, and up to 18 months. from enrollment
* Willing and able to use FDC as advised, including ability to:
* (1) Abstain from penile-vaginal intercourse on days indicated as "Use protection" OR
* (2) Use barrier methods (such as condoms) for penile-vaginal intercourse on days indicated as "Use protection"
* Possession of an iOS mobile device (version 16 or higher) with internet connectivity
* Sufficient English language proficiency and knowledge of English language required for correct use of the intervention and mobile device
* Willing to wear a functional Apple Watch capable of sensing wrist-skin temperature (Series 8 or later, Ultra) while sleeping, with it connected and sharing temperature data to the Flo application
* No known pregnancy at the time of enrollment
* Willing and able to provide valid consent
Exclusion Criteria:
* Current use of any contraceptive medication, implant or technique, including but not limited to:
* Oral contr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Typical-Use Pearl Index in Women Aged 18-35 Years with Regular Menstrual Cycles
Timeframe: Up to 13 menstrual cycles or 18 months from FDC activation, whichever occurs first.