Hypothalamic Amenorrhea, FunctionalREVEALNCT06583408
The REgistry of Very Early Estrogen and AnovuLation
An observational study of Hypothalamic Amenorrhea, Functional and Hypothalamic Amenorrhea, run by Mayo Clinic at 2 sites in United States.
Trial summary
The purpose of this study is to to build a registry of women with early estrogen loss due to Functional Hypothalamic Amenorrhea (FHA) to understand the prevalence, racial and ethnic diversity of this condition. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Hypothalamic Amenorrhea, Functional, Hypothalamic Amenorrhea, Functional Hypogonadotropic Hypogonadism
- What is being tested?
- Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) and REVEAL Questionnaire
- How many people
- 100,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2024to 1 Aug 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
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: The study subjects are women aged 18-40 years old with a diagnosis of Functional Hypothalamic Amenorrhea (FHA) or lab results that are within the inclusion criteria. To ensure accurate case ascertainment before enrollment into the study, volunteers must have a diagnosis of FHA from a provider with previously performed lab tests, which will be reviewed and adjudicated by a women's health expert to confirm a diagnosis of FHA. If the potential participant doesn't have access or cannot obtain the required lab results, they can contact the study team to receive an at-home finger-stick hormone test (U.S. Specialty Labs) paid for by the study.
Who may be able to join
- 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
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- 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
Who cannot join
- Parturition/lactating in the last 6-12 months
- Lack of consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
Chrisandra Shufelt, MD, DLREVEAL@exchange.mayo.edu
Stephanie Faubion, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Chandler E. Palmer, MHA, 904-953-5438, palmer.chandler@mayo.edu
About this study
The purpose of this study is to to build a registry of women with early estrogen loss due to Functional Hypothalamic Amenorrhea (FHA) to understand the prevalence, racial and ethnic diversity of this condition.
- Conditions
- Hypothalamic Amenorrhea, Functional, Hypothalamic Amenorrhea, Functional Hypogonadotropic Hypogonadism
- Being tested
- Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24), REVEAL Questionnaire
- Keywords
- Anovulation, Estrogen Loss, Hypoestrogenemia
- Medical subject headings
- Anovulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)Other
Subjects will complete the ASA food diary for 2 weekdays and 1 weekend day
REVEAL QuestionnaireOther
Subjects will complete the REVEAL questionnaire form. This form includes questions about current and past medical history, including reproductive history, lifestyle specifics, and assessment of current health status.
| Study group | Role | What they receive |
|---|---|---|
| Women with > 3 months amenorrhea | Women aged 18-40 years old with a diagnosis of functional hypothalamic amenorrhea, or lab results that are within the inclusion criteria. Receives: Other: Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24); Other: REVEAL Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Participants
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.
Measured: 5 years
Secondary outcomes (2)
Assessing the Impact of Amenorrhea on Women's Health: Symptoms, Care Experiences, and Work Productivity
Improve understanding of women's overall experience of Functional Hypothalamic Amenorrhea (FHA) by documenting the types of care received, frequency and quality of healthcare interactions, and patient satisfaction with the care provided. This includes detailed assessments of specific treatments or therapies received, the involvement of multidisciplinary care approaches, and the extent of follow-up care. Additionally, to quantify the impact of FHA on lost work productivity, including the number of workdays missed, impact on work performance, and economic burden associated with amenorrhea-related issues, measured at baseline and then yearly using questionnaires.
Measured: 5 years
Impact of Social, Early Life, and Pregnancy Factors on Functional Hypothalamic Amenorrhea
Enhance the understanding of how social determinants of health-such as socioeconomic status, education, access to healthcare, and community environment-contribute to the development of Functional Hypothalamic Amenorrhea (FHA). Additionally, the study will explore the impact of childhood adversity, including exposure to trauma, abuse, neglect, or chronic stress, on the likelihood of developing FHA. The relationship between pregnancy complications, such as preterm birth, miscarriage, or gestational conditions, and the onset of FHA will also be analyzed. Data will be collected through baseline and annual questionnaires throughout the study, providing a comprehensive understanding of these factors' roles in the development of FHA.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start1 Jul 2024
- Primary completion1 Aug 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothalamic Amenorrhea, FunctionalStudies 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
- Prospective
- Enrolment
- 100,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- 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
- NCT06583408
- Sponsor's protocol ID
- 24-000952
- Acronym
- REVEAL
- Status last verified
- Oct 2025
- First submitted
- 22 Aug 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No