The REgistry of Very Early Estrogen and AnovuLation

Recruiting

• Conditions: Hypothalamic Amenorrhea, Functional; Hypothalamic Amenorrhea; Functional Hypogonadotropic Hypogonadism
• Interventions: Other: Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24); Other: REVEAL Questionnaire

• Registration Number: NCT06583408
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-30
• Last Update Submitted: 2024-08-30
• Study First Posted: 2024-09-04
• Last Update Posted: 2024-09-04
• Primary Completion: 2029-08-01
• Study Completion: 2029-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100000

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

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Exclusion Criteria

• Parturition/lactating in the last 6-12 months
• Lack of consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with > 3 months amenorrhea	Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)	Women aged 18-40 years old with a diagnosis of functional hypothalamic amenorrhea, or lab results that are within the inclusion criteria.
Women with > 3 months amenorrhea	REVEAL Questionnaire	Women aged 18-40 years old with a diagnosis of functional hypothalamic amenorrhea, or lab results that are within the inclusion criteria.

Primary Outcome Measures

Name	Time	Method
Study Participants	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 Outcome Measures

Name	Time	Method
Assessing the Impact of Amenorrhea on Women's Health: Symptoms, Care Experiences, and Work Productivity	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.
Impact of Social, Early Life, and Pregnancy Factors on Functional Hypothalamic Amenorrhea	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States