Menstrual Cycle Study | NCT05999123

Studies
Menstrual Cycle Study

NCT05999123

Sponsor

Fitbit LLC

Status

Completed

Last Update Posted

Dec 20, 2024Actual

Enrollment

143Actual

Phase

Not provided

Conditions

Menstruation
Ovulation

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 25, 2023Actual

Primary Completion Date

Aug 30, 2024Actual

Completion Date

Aug 30, 2024Actual

First Submitted Date

Aug 13, 2023

First Submission Date that Met QC Criteria

Aug 13, 2023

First Posted Date

Aug 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2024

Last Update Posted Date

Dec 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

143Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ovulation Day Estimation	The algorithm's estimated ovulation day compared to the reference urinary ovulation predictor kits (OPK).	6 months

Secondary Outcomes

Measure	Description	Time Frame
Menstruation Day Estimation	The algorithm's estimated menstruation date(s) compared to participants' self-reported menstruation date(s).	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

Healthy, menstruating individuals between 18 to 42 years of age who meet eligibility criteria from one or more clinical research sites in the United States.

Sampling Method

Non-Probability Sample