The REgistry of Very Early Estrogen and AnovuLation

NCT06583408 | Recruiting

• 1 other identifier: 24-000952
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hypothalamic Amenorrhea, Functional; Hypothalamic Amenorrhea; Functional Hypogonadotropic Hypogonadism

Keywords

Anovulation; Estrogen Loss; Hypoestrogenemia

Outcome Measures

Primary Outcomes (1)

• 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.

  5 years

Secondary Outcomes (2)

• Assessing the Impact of Amenorrhea on Women's Health: Symptoms, Care Experiences, and Work Productivity

  5 years

• Impact of Social, Early Life, and Pregnancy Factors on Functional Hypothalamic Amenorrhea

  5 years

Study Arms (1)

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.

Other: Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24); Other: REVEAL Questionnaire

Interventions

Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) OTHER

Subjects will complete the ASA food diary for 2 weekdays and 1 weekend day

Women with > 3 months amenorrhea

REVEAL Questionnaire OTHER

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.

Women with > 3 months amenorrhea

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Anovulation

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Chrisandra Shufelt, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chandler E. Palmer, MHA

CONTACT

904-953-5438; palmer.chandler@mayo.edu

Chrisandra L Shufelt, MD

CONTACT

904 953-7224; DLREVEAL@exchange.mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair and Professor of Medicine

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: September 4, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: November 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)