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Can your phone prevent pregnancy? flo app trial recruits 3,800 women

NCT ID NCT07630064

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether the Flo app, when used with an Apple Watch that measures wrist temperature overnight, can help women prevent pregnancy without hormones or devices. About 3,800 women in the US will use the app as their only birth control for up to 13 cycles. The app tells them which days they are fertile and should use protection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Flo Digital Contraceptive app (software as a medical device) used with an Apple Watch for temperature tracking
What this could lead to
If successful, this could provide a hormone-free, non-invasive contraceptive option that helps women prevent pregnancy using only their smartphone and a smartwatch.
What could go wrong
This is a single-arm study with no comparison group, and effectiveness depends on consistent daily use. The app may not work as well for women with irregular cycles or those who forget to wear the watch.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 3,800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 contraceptive pills * Hormonal implants, injections, vaginal rings or transdermal patches * Intrauterine devices (copper and/or levonorgestrel) * Surgical sterilization (tubal ligation, salpingectomy, intrafallopian tube coils) * ≤12 weeks postpartum (second or third trimester pregnancy)\* * \*Includes terminations of any pregnancy \>14 weeks OR have given birth \>12 weeks postpartum without return of at least one menses * Postabortion (first trimester miscarriage, ectopic, termination) who have: * History of cycles outside the 21-35 day range, OR * Not had return of at least one menses following the abortion * Currently lactating (breastfeeding, pumping or otherwise), regardless of interval since last pregnancy * Had fewer than 9 menstrual cycles in the past 12 months * Have received medical advice from a healthcare provider that pregnancy is medically contraindicated, irrespective of whether this is due to a medical condition or risk, or due to medication being taken, or other reason. * Participants must be willing to NOT use condoms for penile-vaginal intercourse. Those who are unable or unwilling to restrict use of condoms for penile-vaginal intercourse for any reason, including but not limited to compromising health and/or safety of self or others will be excluded * Note: Use of barrier contraceptive for sexual encounters that could not result in pregnancy, such as oral or anal sex, is not restricted * Any condition or circumstance that, in the opinion of the Lead Investigator (LI) or designee, would compromise the participant's ability to comply with the study protocol, pose an unacceptable risk to the participant's safety or well-being, or interfere with the evaluation of study objectives * Concurrent participation in another research study that aims to prevent pregnancy * Extreme shift work patterns (e.g., unpredictable or rotating shifts changing more frequently than weekly, frequent time zone changes) that prevent consistent sleep schedules necessary for reliable temperature measurement

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Lindus Health

    RECRUITING

    Boston, Massachusetts, 02111, United States

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