Evaluation of The Cycle SyncingⓇ Method: A 12-Week Virtual Clinical Trial
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedFirst Submitted
Initial submission to the registry
November 19, 2025
CompletedFirst Posted
Study publicly available on registry
December 16, 2025
CompletedDecember 16, 2025
December 1, 2025
5 months
November 19, 2025
December 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (7)
Time to Improvement in Symptom Burden
Baseline, Month 1, Month 2, and Month 3
Change in Luteinizing Hormone (LH) levels
Baseline, Month 1, Month 2, Month 3
Variations in Basal Body Temperature (BBT)
Baseline, Month 1, Month 2, Month 3
Impact on Blood Glucose Levels
Baseline, Month 1, Month 2, Month 3
Change in Estrone-3-glucuronide (E3G) levels
Baseline, Month 1, Month 2, Month 3
- +2 more secondary outcomes
Study Arms (1)
Cycle SyncingⓇ Intervention Group
EXPERIMENTALParticipants will follow the Cycle SyncingⓇ Method daily for 12 weeks using the MyFLO app.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- FLO LIVING, LLClead
- Citruslabscollaborator
Study Sites (1)
Citruslabs
Las Vegas, Nevada, 89118, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2025
First Posted
December 16, 2025
Study Start
May 1, 2025
Primary Completion
October 1, 2025
Study Completion
October 1, 2025
Last Updated
December 16, 2025
Record last verified: 2025-12