BridgeMD
New treatment option for Contraception Use
Official title Flo Digital Contraceptive Study
ClinicalTrials.gov ID: NCT07630064
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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)\
See the full eligibility 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.