Menstrual Cycle Study

Sponsor

Fitbit LLC (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05999123

Collaborator

(none)

150

Enrollment

Location

9.2

Anticipated Duration (Months)

16.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A data collection study to develop algorithms to estimate menstrual cycle phases.

Condition or Disease	Intervention/Treatment	Phase
Menstruation Ovulation

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Study for the Development of Biometrics-informed Menstrual Cycle Algorithms

Actual Study Start Date :

Jul 25, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Ovulation Day Estimation [6 months]
The algorithm's estimated ovulation day compared to the reference urinary ovulation predictor kits (OPK).

Secondary Outcome Measures

Menstruation Day Estimation [6 months]
The algorithm's estimated menstruation date(s) compared to participants' self-reported menstruation date(s).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 42 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Artemis Headlands LLC (Artemis Institute for Clinical Research)	San Diego	California	United States	92103

Sponsors and Collaborators

Fitbit LLC

Investigators

Principal Investigator: Daniel Johnson, DO, Artemis Institute for Clinical Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fitbit LLC

ClinicalTrials.gov Identifier:

NCT05999123

Other Study ID Numbers:

GH-FH-001

First Posted:

Aug 21, 2023

Last Update Posted:

Aug 24, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Study Results

No Results Posted as of Aug 24, 2023