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 range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Study Participants

Timeframe: 5 years

Trial details

NCT IDNCT06583408

SponsorMayo Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-08-01

Contact for this trial

Chandler E. Palmer, MHA

904-953-5438 palmer.chandler@mayo.edu

View on ClinicalTrials.gov More Hypothalamic Amenorrhea, Functional trials