MenstruationNCT05999123
Menstrual Cycle Study
An observational study of Menstruation and Ovulation, run by Fitbit LLC at 1 site in United States.
Trial summary
A data collection study to develop algorithms to estimate menstrual cycle phases. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstruation, Ovulation
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2023to 30 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Healthy volunteers accepted
- 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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Artemis Headlands LLC (Artemis Institute for Clinical Research)
San Diego, California, 92103
About this study
Official title: Study for the Development of Biometrics-informed Menstrual Cycle Algorithms
A data collection study to develop algorithms to estimate menstrual cycle phases.
- Conditions
- Menstruation, Ovulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulation Day Estimation
The algorithm's estimated ovulation day compared to the reference urinary ovulation predictor kits (OPK).
Measured: 6 months
Secondary outcomes (1)
Menstruation Day Estimation
The algorithm's estimated menstruation date(s) compared to participants' self-reported menstruation date(s).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start25 Jul 2023
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenstruationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fitbit LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Johnson, DO, Principal investigator, Artemis Institute for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999123
- Sponsor's protocol ID
- GH-FH-001
- Status last verified
- Sep 2024
- First submitted
- 13 Aug 2023
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for the Development of Biometrics-informed Menstrual Cycle Algorithms
- ClinicalTrials.gov ID
- NCT05999123
- Acronym / sponsor ID
- GH-FH-001
- Conditions
- Menstruation, Ovulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Fitbit LLCIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A data collection study to develop algorithms to estimate menstrual cycle phases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ovulation Day Estimation
Time frame: 6 months
The algorithm's estimated ovulation day compared to the reference urinary ovulation predictor kits (OPK).
1 secondary outcome
Menstruation Day Estimation
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Johnson, DO principal investigator
Artemis Institute for Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menstruation and Ovulation, run by Fitbit LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovulation Day Estimation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.