Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
143 participants
OBSERVATIONAL
2023-07-25
2024-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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All Participants
Up to 150 participants will be enrolled at one or more clinical research sites in the United States. Participants will be healthy, menstruating individuals between 18 to 42 years of age who meet all eligibility criteria.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
42 Years
FEMALE
Yes
Sponsors
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Fitbit LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Johnson, DO
Role: PRINCIPAL_INVESTIGATOR
Artemis Institute for Clinical Research
Locations
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Artemis Headlands LLC (Artemis Institute for Clinical Research)
San Diego, California, United States
Countries
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Other Identifiers
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GH-FH-001
Identifier Type: -
Identifier Source: org_study_id