Status:
COMPLETED
Menstrual Cycle Study
Lead Sponsor:
Fitbit LLC
Conditions:
Menstruation
Ovulation
Eligibility:
FEMALE
18-42 years
Brief Summary
A data collection study to develop algorithms to estimate menstrual cycle phases.
Eligibility Criteria
Inclusion
- Inclusion:
- Adults who are between 18 - 42 years old at enrollment and menstruate
- Capable of giving informed consent in Spanish or English
- Menstrual cycle lengths between 21- 45 days
- Have tracked menstruation for at least 3 menstrual cycles out of the prior 6 months
- Willing to wear a wrist-worn wearable device continuously for 6 months
- Willing to use an ovulation predictor kit for 6 months
- Willing to report vaccine history
- Owns a smartphone compatible with the study and has access to wi-fi
- Exclusion:
- A citizen of the European Union or United Kingdom
- Trying to conceive during the six-month study period
- Have used specific forms of birth control in the 3 months prior to the study or planning on using specific birth control methods during the study duration
- Participant has undergone hormonal treatment in the past 3 months or planning to do so during the study
- Known history of health-related issues that affect their menstrual cycle, history of pelvic radiation, vasomotor symptoms, endometriosis, fibroids, polyps, ovarian cysts or known history of health-related issues that affect the physiology
- Currently (or within the past 3 months) engaged in health impacting behaviors
- Have been breastfeeding or pregnant in the past 6 months prior to the study
- On medications or taking substances that could affect their menstrual cycle or physiology
- Travel frequently such as crossing more than two time zones at least once every 2 weeks
- Have a known sleeping disorder or consistently work night shifts
Exclusion
Key Trial Info
Start Date :
July 25 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 30 2024
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT05999123
Start Date
July 25 2023
End Date
August 30 2024
Last Update
December 20 2024
Active Locations (1)
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1
Artemis Headlands LLC (Artemis Institute for Clinical Research)
San Diego, California, United States, 92103