Actively Recruiting
The REgistry of Very Early Estrogen and AnovuLation
Led by Mayo Clinic · Updated on 2025-11-21
100000
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to build a registry of women aged 18 to 40 years who experience early estrogen loss due to Functional Hypothalamic Amenorrhea (FHA). The study focuses on understanding how common this condition is and its racial and ethnic diversity among affected women. By gathering detailed information, researchers hope to learn more about FHA's impact on women's health over time. Participants include women diagnosed with FHA or those whose lab results meet specific hormone criteria related to FHA. During the study, women will complete questionnaires such as the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) for diet tracking over three days and the REVEAL questionnaire, which gathers medical, reproductive, lifestyle, and health status information. These tools help researchers collect comprehensive data about the participants. Women will be followed for up to five years, during which researchers will monitor symptoms, care experiences, work productivity, and social or life factors affecting FHA. The study involves regular assessments through questionnaires and hormone evaluations. Participants must be able to give informed consent and read English. The research will provide valuable insights into FHA's effects and support future care strategies.
CONDITIONS
Brief Title
The REgistry of Very Early Estrogen and AnovuLation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 40 years
- 3 or more months of consecutive amenorrhea with a diagnosis of functional hypothalamic amenorrhea or lab results consistent with FHA
- Hormone levels within specified ranges including estradiol below 50pg/mL and negative pregnancy 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 causes like prolactinoma, PCOS, premature ovarian insufficiency, pituitary surgery, infection, or infarction
- Premenopausal status as determined by WISE criteria
- Able to give informed consent
- Able to read English
You will not qualify if you...
- Recent childbirth or lactation 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants complete dietary assessments and health questionnaires to monitor their health status and symptoms related to amenorrhea over time.
Participants complete 2 weekday and 1 weekend day dietary assessments and periodic questionnaires
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
Research Team
C
Chandler E. Palmer, MHA
C
Chrisandra L Shufelt, MD
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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