The REgistry of Very Early Estrogen and AnovuLation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Mayo Clinic
- Enrollment
- 100,000
- Locations
- 1
- Primary Endpoint
- Study Participants
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Study Participants
Time Frame: 5 years
Establish and maintain a comprehensive registry of patients diagnosed with Functional Hypothalamic Amenorrhea (FHA). This registry will include detailed demographic information, clinical data, and longitudinal follow-up to track the prevalence, underlying causes, risk factors, and prognosis of FHA. It will also facilitate the collection of data on racial and ethnic disparities, lifestyle factors, psychological stressors, hormonal imbalances, and the impact of various treatment interventions on long-term health outcomes collected through questionnaires done at baseline and yearly.
Secondary Outcomes
- Assessing the Impact of Amenorrhea on Women's Health: Symptoms, Care Experiences, and Work Productivity(5 years)
- Impact of Social, Early Life, and Pregnancy Factors on Functional Hypothalamic Amenorrhea(5 years)
Investigators
Chrisandra L. Shufelt, MD
Chair and Professor of Medicine
Mayo Clinic