Menstrual Cycle Study

Fitbit

Status: Completed

Conditions: Menstruation; Ovulation

Study type: Observational

Funder types: Industry

Identifiers

NCT05999123

GH-FH-001

Details and patient eligibility

About

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

Enrollment: 143 patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

143 participants in 1 patient group

All Participants

Description:

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.