Hormonal Imbalance, Menstrual Cycle Disorder, Menstrual Symptoms
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTMyFLO App
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.
Sponsors
Citruslabs
FLO LIVING, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
22 Years to 42 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cycle Symptom Burden | Baseline, Month 1, Month 2, and Month 3 | Change in total symptom burden and severity scores as measured by validated symptom questionnaires. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Improvement in Symptom Burden | Baseline, Month 1, Month 2, and Month 3 | Time to statistically significant improvement in symptom burden, based on monthly assessments using validated questionnaires. |
| Change in Luteinizing Hormone (LH) levels | Baseline, Month 1, Month 2, Month 3 | Evaluation of changes in LH levels measured via the MIRA urine device. |
| Variations in Basal Body Temperature (BBT) | Baseline, Month 1, Month 2, Month 3 | 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. |
| Change in Pregnanediol Glucuronide (PdG) levels | Baseline, Month 1, Month 2, Month 3 | Evaluation of changes in PdG levels measured via the MIRA urine device. |
| Change in Estrone-3-glucuronide (E3G) levels | Baseline, Month 1, Month 2, Month 3 | Evaluation of changes in E3G levels measured via the MIRA urine device. |
| Change in Follicle-Stimulating Hormone (FSH) levels | Baseline, Month 1, Month 2, Month 3 | Evaluation of changes in FSH levels measured via the MIRA urine device. |
| Impact on Blood Glucose Levels | Baseline, Month 1, Month 2, Month 3 | Assessment of blood glucose trends throughout the study, with a focus on changes during the luteal phase of the menstrual cycle. |
Countries
United States
Outcome results
None listed