The REgistry of Very Early Estrogen and AnovuLation

Recruiting now

Conditions studied: Hypothalamic Amenorrhea, Functional, Hypothalamic Amenorrhea, Functional Hypogonadotropic Hypogonadism

In brief

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.

Key facts

Study ID

NCT06583408

Run by

Mayo Clinic

People needed

100000

Starts

2024-07-01

Expected to finish

2029-08-01

Last updated by the study team

2025-11-21

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Parturition/lactating in the last 6-12 months
• Lack of consent

Where it is running

• Mayo Clinic — Jacksonville, Florida, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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