An observational study in Hypothalamic Amenorrhea, Functional, Hypothalamic Amenorrhea and Functional Hypogonadotropic Hypogonadism, sponsored by Mayo Clinic. Recruiting at 2 sites in United States. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by Mayo Clinic · Observational
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.
75 studies on the registry are indexed under Anovulation; 7 are open to participants now.
This study's planned enrollment of 100,000 is above the median of 300 across 17 observational studies indexed under Anovulation.
Browse Anovulation studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study subjects are women aged 18-40 years old with a diagnosis of Functional Hypothalamic Amenorrhea (FHA) or lab results that are within the inclusion criteria. To ensure accurate case ascertainment before enrollment into the study, volunteers must have a diagnosis of FHA from a provider with previously performed lab tests, which will be reviewed and adjudicated by a women's health expert to confirm a diagnosis of FHA. If the potential participant doesn't have access or cannot obtain the required lab results, they can contact the study team to receive an at-home finger-stick hormone test (U.S. Specialty Labs) paid for by the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women aged 18-40 years old with a diagnosis of functional hypothalamic amenorrhea, or lab results that are within the inclusion criteria.
Other: Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) · Other: REVEAL Questionnaire
Subjects will complete the ASA food diary for 2 weekdays and 1 weekend day
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.
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
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.
Time frame: 5 years
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2024 (actual). Primary completion is estimated for Aug 2029, 61 months after the start.
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