Hypothalamic AmenorrheaARCHNCT05629377
Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health (ARCH)
An observational study of Hypothalamic Amenorrhea, run by Mayo Clinic at 1 site in United States.
Trial summary
Hypothalamic amenorrhea (HA) occurs during reproductive years and results in stopped menstrual cycles and infertility which can be prolonged from months to years and is characterized by varying combinations of psychosocial stress, anxiety, high levels of physical activity, and/or weight loss. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Hypothalamic Amenorrhea
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2023to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Premenopausal women with hypothalamic amenorrhea at Mayo Clinic Florida.
Who may be able to join
- Secondary amenorrhea of 3 or more consecutive months duration
- Include the screening hormones (eg, estradiol (E2) < 50 pg/ml, Follicle-Stimulating Hormone (FSH) <10 mIU/ml, and Luteinizing Hormone (LH) < 10mIU/ml and other HA-defining hormones); or clinical diagnosis of HA by medical providers.
- Pre-menopause status.
- Able to give informed consent.
Who cannot join
- A diagnosis for secondary amenorrhea including prolactinoma, Polycystic Ovary Syndrome (PCOS), premature ovarian insufficiency, pituitary surgery, infection or infarction
- Pregnancy
- Psychotropic/illicit drug use
- Mental/neurological/major psychological disorders (other than depression and anxiety).
- Parturition/lactating in the last 6-12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health
Hypothalamic amenorrhea (HA) occurs during reproductive years and results in stopped menstrual cycles and infertility which can be prolonged from months to years and is characterized by varying combinations of psychosocial stress, anxiety, high levels of physical activity, and/or weight loss. Data from our group indicates that one-third of women with HA (mean age: 27 yrs) have preclinical cardiovascular disease (CVD) measured noninvasively as vascular dysfunction and vascular inflammation. This study will use HA as a marker of fertility status for cardiovascular health and perform dense-phenotyping using remote patient monitoring (FitBit) and patient reported outcomes (questionnaires) to determine which HA phenotypes are related to preclinical CVD and inflammation.
- Conditions
- Hypothalamic Amenorrhea
- Keywords
- Functional Hypothalamic Amenorrhea, Amenorrhea
- Medical subject headings
- Amenorrhea
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypothalamic Amenorrhea (HA) duration
Duration of HA by month of amenorrhea (absence of menstruation)
Measured: 3 months
Vascular dysfunction
Measured by reactive hyperemic index (RHI)
Measured: 3 months
Psychosocial stress
Measured by NIH PROMIS® short-form questionnaires
Measured: 3 months
Perceived stress
Measured by the validate perceived stress scale questionnaire, a 10-item questionnaire, scores range from 0 to 40; higher scores indicate higher levels of perceived stress.
Measured: 3 months
Step count
Measured by Fitbit Versa 2 watch that tracks steps per day, active and resting heart rate, sleep hours per day
Measured: 3 months
Physical activity level
Measured by Fitbit Versa 2 watch that tracks amount of light physical activity, moderate, and vigorous activity
Measured: 3 months
Heart Rate
Measured by Fitbit Versa 2 watch that tracks heart rate
Measured: 3 months
Caloric intake and nutrition
Measured using a self-reported food diary
Measured: 3 days
Vascular inflammation
concentration of cytokines multiplex immunoassay platform
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start17 Jan 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothalamic AmenorrheaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Chrisandra L. Shufelt, MD, Mayo Clinic
- Investigators
- Chrisandra Shufelt, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629377
- Sponsor's protocol ID
- 22-006348
- Other IDs
- R01HD106096
- Acronym
- ARCH
- Status last verified
- Jun 2026
- First submitted
- 14 Oct 2022
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health
- ClinicalTrials.gov ID
- NCT05629377
- Acronym / sponsor ID
- ARCH / 22-006348
- Conditions
- Hypothalamic Amenorrhea
- Keywords
- Functional Hypothalamic Amenorrhea, Amenorrhea
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 29 Nov 2022 (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.
Hypothalamic amenorrhea (HA) occurs during reproductive years and results in stopped menstrual cycles and infertility which can be prolonged from months to years and is characterized by varying combinations of psychosocial stress, anxiety, high levels of physical activity, and/or weight loss. Data from our group indicates that one-third of women with HA (mean age: 27 yrs) have preclinical cardiovascular disease (CVD) measured noninvasively as vascular dysfunction and vascular inflammation. This study will use HA as a marker of fertility status for cardiovascular health and perform dense-phenotyping using remote patient monitoring (FitBit) and patient reported outcomes (questionnaires) to determine which HA phenotypes are related to preclinical CVD and inflammation.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Premenopausal women with hypothalamic amenorrhea at Mayo Clinic Florida.
Key inclusion criteria (4 listed)
- Secondary amenorrhea of 3 or more consecutive months duration
- Include the screening hormones (eg, estradiol (E2) < 50 pg/ml, Follicle-Stimulating Hormone (FSH) <10 mIU/ml, and Luteinizing Hormone (LH) < 10mIU/ml and other HA-defining hormones); or clinical diagnosis of HA by medical providers.
- Pre-menopause status.
- Able to give informed consent.
Key exclusion criteria (5 listed)
- A diagnosis for secondary amenorrhea including prolactinoma, Polycystic Ovary Syndrome (PCOS), premature ovarian insufficiency, pituitary surgery, infection or infarction
- Pregnancy
- Psychotropic/illicit drug use
- Mental/neurological/major psychological disorders (other than depression and anxiety).
- Parturition/lactating in the last 6-12 months.
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
Hypothalamic Amenorrhea (HA) duration
Time frame: 3 months
Duration of HA by month of amenorrhea (absence of menstruation)
Vascular dysfunction
Time frame: 3 months
Measured by reactive hyperemic index (RHI)
Psychosocial stress
Time frame: 3 months
Measured by NIH PROMIS® short-form questionnaires
Perceived stress
Time frame: 3 months
Measured by the validate perceived stress scale questionnaire, a 10-item questionnaire, scores range from 0 to 40; higher scores indicate higher levels of perceived stress.
Step count
Time frame: 3 months
Measured by Fitbit Versa 2 watch that tracks steps per day, active and resting heart rate, sleep hours per day
Physical activity level
Time frame: 3 months
Measured by Fitbit Versa 2 watch that tracks amount of light physical activity, moderate, and vigorous activity
Heart Rate
Time frame: 3 months
Measured by Fitbit Versa 2 watch that tracks heart rate
Caloric intake and nutrition
Time frame: 3 days
Measured using a self-reported food diary
Vascular inflammation
Time frame: 3 months
concentration of cytokines multiplex immunoassay platform
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
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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.
Chrisandra Shufelt, MD principal investigator
Mayo Clinic
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 Hypothalamic Amenorrhea, run by Mayo Clinic 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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Hypothalamic Amenorrhea (HA) duration (time frame: 3 months). The study lists 9 primary outcomes in all. 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 4 Jun 2026.