Flo Digital Contraceptive Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFlo Health Inc.

About 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

Eligibility criteria

Qualifiers

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).

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Flo Digital Contraceptive

Treatment groups

3,800 Participants
are divided into 1 treatment group

Sponsors and collaborators

Flo Health Inc.

Lead sponsor

Lindus Health

Collaborator