Status:
RECRUITING
The REgistry of Very Early Estrogen and AnovuLation
Lead Sponsor:
Mayo Clinic
Conditions:
Hypothalamic Amenorrhea, Functional
Hypothalamic Amenorrhea
Eligibility:
FEMALE
18-40 years
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 ...
Eligibility Criteria
Inclusion
- 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
- Parturition/lactating in the last 6-12 months
- Lack of consent
Key Trial Info
Start Date :
July 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
100000 Patients enrolled
Trial Details
Trial ID
NCT06583408
Start Date
July 1 2024
End Date
August 1 2029
Last Update
November 21 2025
Active Locations (2)
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1
Mayo Clinic
Jacksonville, Florida, United States, 32224
2
Mayo Clinic
Rochester, Minnesota, United States, 55905