The REgistry of Very Early Estrogen and AnovuLation (NCT06583408) | Clinical Trial Compass
RecruitingNot Applicable
The REgistry of Very Early Estrogen and AnovuLation
United States100,000 participantsStarted 2024-07-01
Plain-language 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.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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