Actively Recruiting

Age: 18Years - 40Years
FEMALE
NCT06583408

The REgistry of Very Early Estrogen and AnovuLation

Led by Mayo Clinic · Updated on 2025-11-21

100000

Participants Needed

2

Research Sites

265 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The REgistry of Very Early Estrogen and AnovuLation

Who Can Participate

Age: 18Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 40 years
  • At least 3 consecutive months of amenorrhea with diagnosis or hormone screening consistent with functional hypothalamic amenorrhea
  • Hormone levels meeting specified ranges including estradiol < 50 pg/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
  • Negative urine or serum human chorionic gonadotropin test
  • LH to FSH ratio less than 1
  • No male-like hair growth on upper lip, chin, chest, abdomen, buttocks, or back
  • No diagnosis of secondary amenorrhea conditions such as prolactinoma, PCOS, premature ovarian insufficiency, pituitary surgery, infection, or infarction
  • Premenopausal status as determined by WISE criteria
  • Able to give informed consent and read English
Not Eligible

You will not qualify if you...

  • Given birth or breastfeeding within the last 6 to 12 months
  • Lack of consent to participate

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Mayo Clinic

Jacksonville, Florida, United States, 32224

Actively Recruiting

2

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

C

Chandler E. Palmer, MHA

CONTACT

C

Chrisandra L Shufelt, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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The REgistry of Very Early Estrogen and AnovuLation | DecenTrialz