Back to search results

REVEAL Registry for Functional Hypothalamic Amenorrhea

This study, called REVEAL, is building a registry of women with Functional Hypothalamic Amenorrhea (FHA). FHA is a condition where you stop having periods due to low estrogen levels. The goal is to understand how common FHA is and its impact across different racial and ethnic groups. If you are a woman between 18 and 40 years old and have been diagnosed with FHA, or have hormone levels consistent with FHA (like low estradiol, LH, or FSH), you might be able to join. Participants will complete an Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) for three days and answer questions in the REVEAL Questionnaire about their health and lifestyle. The study will look at participants over 5 years.

Study design
This is an observational study aiming to enroll 100,000 women. It is not testing a new treatment but rather collecting information about a health condition.
What's involved
You would complete a dietary assessment for two weekdays and one weekend day, and fill out a questionnaire about your medical history, reproductive history, and lifestyle.
Compensation
Not stated in the trial record.
Follow-up
Participants will be studied for 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06583408

The REgistry of Very Early Estrogen and AnovuLation

Recruiting
Not specifiedAges 18–40Observational
Mayo Clinic
~100,000 participants
Updated 2025-11-21 on ClinicalTrials.gov
What's tested:Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)REVEAL Questionnaire

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Study Participants
Measured over 5 years

Conditions

Hypothalamic Amenorrhea, Functional
Hypothalamic Amenorrhea
Functional Hypogonadotropic Hypogonadism

Explore related trials

AnovulationHypoestrogenemiaHypothalamic amenorrhea, functionalEstradiolFLT4 GeneFollicle-Stimulating HormoneFree testosteroneLuteinizing HormoneMuellerian-Inhibiting FactorProlactinTestosterone

Where it's being run

2 sites across 2 states
Florida1
Minnesota1

Study leadership

  • Chrisandra Shufelt, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Chandler E. Palmer, MHA
[email protected]
904-953-5438
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

3 or more months of consecutive amenorrhea with a diagnosis of functional hypothalamic amenorrhea or screening hormones consistent with functional hypothalamic amenorrhea including but not limited to:
Estradiol: \< 50pg/mL
LH: \< 10 IU/mL
FSH: \< 10 IU
Testosterone: 2 - 45 ng/dL
Free Testosterone: 0.1 - 6.4 pg/mL
FT4: 0.93 - 1.70 ng/dL
Prolactin: \< 20 ng/mL
AMH: \> 1 ng/mL
Urine or serum human chorionic gonadotropin: Negative
LH:FSH Ratio \<1
No signs of male-like hair growth on the upper lip, chin, chest, abdomen, buttocks, or back
Does not have a diagnosis for secondary amenorrhea, including prolactinoma, PCOS, premature ovarian insufficiency, pituitary surgery, infection, or infarction
Premenopausal status determined by WISE criteria
Able to give informed consent
Able to read English

Exclusion

Parturition/lactating in the last 6-12 months
Lack of consent

What this trial measures

  • Study Participants5 years

    Establish and maintain a comprehensive registry of patients diagnosed with Functional Hypothalamic Amenorrhea (FHA). This registry will include detailed demographic information, clinical data, and longitudinal follow-up to track the prevalence, underlying causes, risk factors, and prognosis of FHA. It will also facilitate the collection of data on racial and ethnic disparities, lifestyle factors, psychological stressors, hormonal imbalances, and the impact of various treatment interventions on long-term health outcomes collected through questionnaires done at baseline and yearly.