Menstrual Cycle Study

Menstruation Clinical Trial

Official title:

Study for the Development of Biometrics-informed Menstrual Cycle Algorithms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05999123
• Other study ID #: GH-FH-001
• Status: Recruiting
• Start date: July 25, 2023
• Est. completion date: May 2024

Study information

• Verified date: August 2023
• Source: Fitbit LLC
• Contact: Artemis Research
• Phone: 855-367-8834
• Email: recruitment[@]artemis-research.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Menstruation
• Ovulation

Locations

Country	Name	City	State
United States	Artemis Headlands LLC (Artemis Institute for Clinical Research)	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Fitbit LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovulation Day Estimation	The algorithm's estimated ovulation day compared to the reference urinary ovulation predictor kits (OPK).	6 months
Secondary	Menstruation Day Estimation	The algorithm's estimated menstruation date(s) compared to participants' self-reported menstruation date(s).	6 months