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Could a stopped period warn of heart trouble? mayo clinic investigates

NCT ID NCT05629377

Knowledge-focused Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at young women with hypothalamic amenorrhea (missed periods for months or years) to see if their condition is linked to early signs of heart disease. Researchers will use Fitbit trackers and questionnaires to measure stress, activity, and diet, along with blood tests for inflammation. The goal is to understand which women are most at risk, not to test a treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help identify which women with hypothalamic amenorrhea are at higher risk for heart disease, leading to earlier monitoring or prevention strategies.
What could go wrong
This is an observational study, not a treatment trial. It will not directly improve health, and results may not apply to all women with the condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Premenopausal women with hypothalamic amenorrhea at Mayo Clinic Florida.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

amenorrhea functional hypothalamic amenorrhea

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypothalamic amenorrhea

Contacts and locations

Locations

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.