The REgistry of Very Early Estrogen and AnovuLation
Mayo Clinic
100,000 participants
Jul 1, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria16
- 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 Criteria2
- Parturition/lactating in the last 6-12 months
- Lack of consent
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Subjects will complete the ASA food diary for 2 weekdays and 1 weekend day
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.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06583408