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OpenTrials
Completed

NCT Number: NCT07286136

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

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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Key information

Conditions

Menstrual Cycle Disorder Hormonal Imbalance Menstrual Symptoms Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

22 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Las Vegas, Nevada, 89118, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

FLO LIVING, LLC

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 16, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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