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Recruiting

NCT Number: NCT06583408

The REgistry of Very Early Estrogen and AnovuLation

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic, Jacksonville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Assessing the Impact of Amenorrhea on Women's Health: Symptoms, Care Experiences, and Work Productivity

    Time frame: 5 years

    Improve understanding of women's overall experience of Functional Hypothalamic Amenorrhea (FHA) by documenting the types of care received, frequency and quality of healthcare interactions, and patient satisfaction with the care provided. This includes detailed assessments of specific treatments or therapies received, the involvement of multidisciplinary care approaches, and the extent of follow-up care. Additionally, to quantify the impact of FHA on lost work productivity, including the number of workdays missed, impact on work performance, and economic burden associated with amenorrhea-related issues, measured at baseline and then yearly using questionnaires.

  2. Impact of Social, Early Life, and Pregnancy Factors on Functional Hypothalamic Amenorrhea

    Time frame: 5 years

    Enhance the understanding of how social determinants of health-such as socioeconomic status, education, access to healthcare, and community environment-contribute to the development of Functional Hypothalamic Amenorrhea (FHA). Additionally, the study will explore the impact of childhood adversity, including exposure to trauma, abuse, neglect, or chronic stress, on the likelihood of developing FHA. The relationship between pregnancy complications, such as preterm birth, miscarriage, or gestational conditions, and the onset of FHA will also be analyzed. Data will be collected through baseline and annual questionnaires throughout the study, providing a comprehensive understanding of these factors' roles in the development of FHA.

Study contacts

Contact information is provided by the study sponsor or research team.

Chandler E. Palmer, MHA

CONTACT

[email protected]

904-953-5438

Chrisandra L Shufelt, MD

CONTACT

[email protected]

904 953-7224

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Acronym: REVEAL

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Sep 4, 2024
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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