Evaluation of The Cycle SyncingⓇ Method: A 12-Week Virtual Clinical Trial

December 2, 2025 updated by: FLO LIVING, LLC
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89118
        • Citruslabs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cycle SyncingⓇ Intervention Group
Participants will follow the Cycle SyncingⓇ Method daily for 12 weeks using the MyFLO app.
Dietary supplement: MyFLO 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Month 1, Month 2, and Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Improvement in Symptom Burden
Time Frame: Baseline, Month 1, Month 2, and Month 3
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
Time Frame: Baseline, Month 1, Month 2, Month 3
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)
Time Frame: 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.
Baseline, Month 1, Month 2, Month 3
Impact on Blood Glucose Levels
Time Frame: 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.
Baseline, Month 1, Month 2, Month 3
Change in Estrone-3-glucuronide (E3G) levels
Time Frame: Baseline, Month 1, Month 2, Month 3
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
Time Frame: Baseline, Month 1, Month 2, Month 3
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
Time Frame: Baseline, Month 1, Month 2, Month 3
Evaluation of changes in FSH levels measured via the MIRA urine device.
Baseline, Month 1, Month 2, Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FLO LIVING, LLC

Collaborators

Citruslabs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Actual)

October 1, 2025

Study Completion (Actual)

October 1, 2025

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLOLIV202503

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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