The REgistry of Very Early Estrogen and AnovuLation

Mayo Clinic100,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100,000

Conditions

Hypothalamic Amenorrhea, Functional Hypothalamic Amenorrhea Functional Hypogonadotropic Hypogonadism

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 QuestionnaireOTHER

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

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (2)

Mayo Clinic

Jacksonville, Florida, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

Study Participants

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.

Time frame: 5 years

Secondary Outcomes

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

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.

Time frame: 5 years

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

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.

Central Contacts

Chandler E. Palmer, MHA

CONTACT

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

Chrisandra L Shufelt, MD

CONTACT

904 953-7224 DLREVEAL@exchange.mayo.edu

Data from ClinicalTrials.gov

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