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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cycle SyncingⓇ Intervention Group | Experimental | Participants will follow the Cycle SyncingⓇ Method daily for 12 weeks using the MyFLO app. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyFLO App | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cycle Symptom Burden | Change in total symptom burden and severity scores as measured by validated symptom questionnaires. | Baseline, Month 1, Month 2, and Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Improvement in Symptom Burden | Time to statistically significant improvement in symptom burden, based on monthly assessments using validated questionnaires. | Baseline, Month 1, Month 2, and Month 3 |
| Change in Luteinizing Hormone (LH) levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Las Vegas | Nevada | 89118 | United States |
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| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Evaluation of changes in LH levels measured via the MIRA urine device.
| 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. | 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. | 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. | 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. | 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. | Baseline, Month 1, Month 2, Month 3 |