Menstrual Cycle DisorderNCT07286136
Evaluation of The Cycle SyncingⓇ Method: A 12-Week Virtual Clinical Trial
A study testing MyFLO App in people with Menstrual Cycle Disorder and Menstrual Symptoms, run by FLO LIVING, LLC at 1 site in United States.
Trial summary
This 12-week, 100% virtual single-group open-label trial evaluates the Cycle SyncingⓇ Method using the MyFLO app, MIRA hormonal monitoring, and continuous glucose monitoring to assess reduction in menstrual cycle symptom burden and hormonal regulation. Read more about this study
- Who is it for?
- Ages 22 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Cycle Disorder, Menstrual Symptoms, Hormonal Imbalance
- What is being tested?
- MyFLO App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female participants aged 22 - 42 years
- Regular menstrual cycles
- Willingness and ability to comply with daily app usage and device protocols
- Access to a compatible smartphone and reliable internet connection
- Ability to attend a weekly virtual call with study personnel
Who cannot join
- Current pregnancy or breastfeeding
- Use of hormonal contraceptives or other medications known to alter menstrual cycle physiology
- Presence of significant comorbidities or chronic conditions that may interfere with study participation
- Any condition that, in the investigator's opinion, would make participation unsafe
Trial locations and contacts
1 site in 1 country.
About this study
This 12-week, 100% virtual single-group open-label trial evaluates the Cycle SyncingⓇ Method using the MyFLO app, MIRA hormonal monitoring, and continuous glucose monitoring to assess reduction in menstrual cycle symptom burden and hormonal regulation.
- Being tested
- MyFLO App
- Medical subject headings
- Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyFLO AppDietary supplement
Participants follow the Cycle SyncingⓇ Method using the MyFLO app daily for 12 weeks. This includes personalized food and workout plans, symptom logging, hormonal testing with MIRA devices (urine and BBT), continuous glucose monitoring (CGM), and weekly virtual coaching sessions.
| Study group | Role | What they receive |
|---|---|---|
| Cycle SyncingⓇ Intervention Group | Experimental | Participants will follow the Cycle SyncingⓇ Method daily for 12 weeks using the MyFLO app. Receives: Dietary Supplement: MyFLO App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cycle Symptom Burden
Change in total symptom burden and severity scores as measured by validated symptom questionnaires.
Measured: Baseline, Month 1, Month 2, and Month 3
Secondary outcomes (7)
Time to Improvement in Symptom Burden
Time to statistically significant improvement in symptom burden, based on monthly assessments using validated questionnaires.
Measured: Baseline, Month 1, Month 2, and Month 3
Change in Luteinizing Hormone (LH) levels
Evaluation of changes in LH levels measured via the MIRA urine device.
Measured: Baseline, Month 1, Month 2, Month 3
Variations in Basal Body Temperature (BBT)
Assessment of blood glucose trends throughout the study, with a focus on changes during the luteal phase of the menstrual cycle. Data will be collected continuously via CGM and analyzed monthly.
Measured: Baseline, Month 1, Month 2, Month 3
Impact on Blood Glucose Levels
Assessment of blood glucose trends throughout the study, with a focus on changes during the luteal phase of the menstrual cycle.
Measured: Baseline, Month 1, Month 2, Month 3
Change in Estrone-3-glucuronide (E3G) levels
Evaluation of changes in E3G levels measured via the MIRA urine device.
Measured: Baseline, Month 1, Month 2, Month 3
Change in Pregnanediol Glucuronide (PdG) levels
Evaluation of changes in PdG levels measured via the MIRA urine device.
Measured: Baseline, Month 1, Month 2, Month 3
Change in Follicle-Stimulating Hormone (FSH) levels
Evaluation of changes in FSH levels measured via the MIRA urine device.
Measured: Baseline, Month 1, Month 2, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 May 2025
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual Cycle DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- FLO LIVING, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286136
- Sponsor's protocol ID
- FLOLIV202503
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Cycle SyncingⓇ Method: A 12-Week Virtual Clinical Trial
- ClinicalTrials.gov ID
- NCT07286136
- Acronym / sponsor ID
- FLOLIV202503
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- FLO LIVING, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 12-week, 100% virtual single-group open-label trial evaluates the Cycle SyncingⓇ Method using the MyFLO app, MIRA hormonal monitoring, and continuous glucose monitoring to assess reduction in menstrual cycle symptom burden and hormonal regulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cycle SyncingⓇ Intervention Group | Experimental | Dietary Supplement: MyFLO AppParticipants will follow the Cycle SyncingⓇ Method daily for 12 weeks using the MyFLO app. |
Who may qualify
- Ages
- 22 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female participants aged 22 - 42 years
- Regular menstrual cycles
- Willingness and ability to comply with daily app usage and device protocols
- Access to a compatible smartphone and reliable internet connection
- Ability to attend a weekly virtual call with study personnel
Key exclusion criteria (4 listed)
- Current pregnancy or breastfeeding
- Use of hormonal contraceptives or other medications known to alter menstrual cycle physiology
- Presence of significant comorbidities or chronic conditions that may interfere with study participation
- Any condition that, in the investigator's opinion, would make participation unsafe
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyFLO AppParticipants follow the Cycle SyncingⓇ Method using the MyFLO app daily for 12 weeks. This includes personalized food and workout plans, symptom logging, hormonal testing with MIRA devices (urine and BBT), continuous glucose monitoring (CGM), and weekly virtual coaching sessions. | Dietary supplement | Cycle SyncingⓇ Intervention Group |
Primary outcome
Change in Cycle Symptom Burden
Time frame: Baseline, Month 1, Month 2, and Month 3
Change in total symptom burden and severity scores as measured by validated symptom questionnaires.
7 secondary outcomes
Time to Improvement in Symptom Burden
Time frame: Baseline, Month 1, Month 2, and Month 3
Change in Luteinizing Hormone (LH) levels
Time frame: Baseline, Month 1, Month 2, Month 3
Variations in Basal Body Temperature (BBT)
Time frame: Baseline, Month 1, Month 2, Month 3
Impact on Blood Glucose Levels
Time frame: Baseline, Month 1, Month 2, Month 3
Change in Estrone-3-glucuronide (E3G) levels
Time frame: Baseline, Month 1, Month 2, Month 3
Change in Pregnanediol Glucuronide (PdG) levels
Time frame: Baseline, Month 1, Month 2, Month 3
Change in Follicle-Stimulating Hormone (FSH) levels
Time frame: Baseline, Month 1, Month 2, Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyFLO App in people with Menstrual Cycle Disorder and Menstrual Symptoms, run by FLO LIVING, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cycle Symptom Burden (time frame: Baseline, Month 1, Month 2, and Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025; AzTrials last refreshed its copy on 27 Oct 2026.