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Recruiting NCT06583408

The REgistry of Very Early Estrogen and AnovuLation

Trial Parameters

Condition Hypothalamic Amenorrhea, Functional
Sponsor Mayo Clinic
Study Type OBSERVATIONAL
Phase N/A
Enrollment 100,000
Sex FEMALE
Min Age 18 Years
Max Age 40 Years
Start Date 2024-07-01
Completion 2029-08-01
Interventions
Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)REVEAL Questionnaire

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.

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

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