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Recruiting NCT06583408

The REgistry of Very Early Estrogen and AnovuLation

— Observational Hypothalamic Amenorrhea, Functional Hypothalamic Amenorrhea Functional Hypogonadotropic Hypogonadism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24), REVEAL Questionnaire.
Who it may be relevant to
Registry conditions: Hypothalamic Amenorrhea, Functional, Hypothalamic Amenorrhea, Functional Hypogonadotropic Hypogonadism. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)
    Subjects will complete the ASA food diary for 2 weekdays and 1 weekend day
  • Other REVEAL Questionnaire
    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.

Primary outcome measures

  • Study Participants [Time frame: 5 years]
Secondary outcome measures (2)
  • Assessing the Impact of Amenorrhea on Women's Health: Symptoms, Care Experiences, and Work Productivity [Time frame: 5 years]
  • Impact of Social, Early Life, and Pregnancy Factors on Functional Hypothalamic Amenorrhea [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • 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 criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 2 centers
  • Mayo Clinic — Jacksonville
  • Mayo Clinic — Rochester

Identifiers

NCT: NCT06583408 · 24-000952

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗