The REgistry of Very Early Estrogen and AnovuLation (REVEAL)

Mayo Clinic

Status: Enrolling

Conditions: Hypothalamic Amenorrhea, Functional; Hypothalamic Amenorrhea; Functional Hypogonadotropic Hypogonadism

Treatments: Other: REVEAL Questionnaire; Other: Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)

Study type: Observational

Funder types: Other

Identifiers

NCT06583408

24-000952

Details and patient eligibility

About

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.

Enrollment: 100,000 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

100,000 participants in 1 patient group

Women with > 3 months amenorrhea

Description:

Women aged 18-40 years old with a diagnosis of functional hypothalamic amenorrhea, or lab results that are within the inclusion criteria.

Treatment:

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

Other: REVEAL Questionnaire