Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100000 participants
OBSERVATIONAL
2024-07-01
2029-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Women with > 3 months amenorrhea
Women aged 18-40 years old with a diagnosis of functional hypothalamic amenorrhea, or lab results that are within the inclusion criteria.
Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)
Subjects will complete the ASA food diary for 2 weekdays and 1 weekend day
REVEAL Questionnaire
Subjects will complete the REVEAL questionnaire form. This form includes questions about current and past medical history, including reproductive history, lifestyle specifics, and assessment of current health status.
Interventions
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Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)
Subjects will complete the ASA food diary for 2 weekdays and 1 weekend day
REVEAL Questionnaire
Subjects will complete the REVEAL questionnaire form. This form includes questions about current and past medical history, including reproductive history, lifestyle specifics, and assessment of current health status.
Eligibility Criteria
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Inclusion Criteria
* 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
* Lack of consent
18 Years
40 Years
FEMALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Chrisandra L. Shufelt, MD
Chair and Professor of Medicine
Principal Investigators
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Chrisandra Shufelt, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Jacksonville, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24-000952
Identifier Type: -
Identifier Source: org_study_id
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