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The REgistry of Very Early Estrogen and AnovuLation

RecruitingObservational study

Who can join

Ages 18 to 40 · Women

Full 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

About the 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.

What is being tested

Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) (other)
REVEAL Questionnaire (other)

Sponsor: Mayo Clinic · Participants: 100,000 · Started: Jul 1, 2024

Contact the study team

Chandler E. Palmer, MHA · Phone: 904-953-5438
Chrisandra L Shufelt, MD · Phone: 904 953-7224

Official record on ClinicalTrials.gov — NCT06583408

Locations in the U.S.

Florida	Mayo Clinic, Jacksonville
Minnesota	Mayo Clinic, Rochester

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.