Recruiting

Estrogen & Anovulation

Sponsor:

Mayo Clinic

Code:

NCT06583408

Conditions

Hypothalamic Amenorrhea, Functional

Hypothalamic Amenorrhea

Functional Hypogonadotropic Hypogonadism

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)

REVEAL Questionnaire

Study Details

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.

Conditions

Hypothalamic Amenorrhea, Functional

Hypothalamic Amenorrhea

Functional Hypogonadotropic Hypogonadism

Study ID

NCT06583408

Start date

Jul 1, 2024

Status verified date

Oct, 2025

Completion date

Aug 1, 2029

Anticipated

Primary completion date

Aug 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Study Participants [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Chandler E. Palmer, MHA

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

Chrisandra L Shufelt, MD

904 953-7224DLREVEAL@exchange.mayo.edu

Locations

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Chrisandra Shufelt, MD

DLREVEAL@exchange.mayo.edu

Principal Investigator:

Chrisandra Shufelt, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Chandler E. Palmer, MHA

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

More Information

Sponsor

Mayo Clinic

Last update posted

Nov 21, 2025

Last verified

Oct, 2025

Keywords

  • Anovulation
  • Estrogen Loss
  • Hypoestrogenemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-11-21.