The REgistry of Very Early Estrogen and AnovuLation

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT06583408
Status
Recruiting
Apply to this trial

Conditions

  • Functional Hypogonadotropic Hypogonadism
  • Hypothalamic Amenorrhea
  • Hypothalamic Amenorrhea, Functional

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) — OTHER
    Subjects will complete the ASA food diary for 2 weekdays and 1 weekend day
  • REVEAL Questionnaire — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jul 1, 2024
Status verified
Oct 2025
Primary completion
Aug 1, 2029
Completion
Aug 1, 2029

Study Design

Enrollment
100,000 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Study Participants [ Time Frame: 5 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo ClinicJacksonvilleFlorida32224
Chrisandra Shufelt, MD
[email protected]
Stephanie Faubion, MD (SUB_INVESTIGATOR)
Chrisandra Shufelt, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Chandler E. Palmer, MHA
[email protected]
904-953-5438

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