Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-01-13 @ 6:05 PM
Study NCT ID:
NCT06583408
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2024-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The REgistry of Very Early Estrogen and AnovuLation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000858', 'term': 'Anovulation'}], 'ancestors': [{'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2024-08-22', 'studyFirstSubmitQcDate': '2024-08-30', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study Participants', 'timeFrame': '5 years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': "Assessing the Impact of Amenorrhea on Women's Health: Symptoms, Care Experiences, and Work Productivity", 'timeFrame': '5 years', 'description': "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."}, {'measure': 'Impact of Social, Early Life, and Pregnancy Factors on Functional Hypothalamic Amenorrhea', 'timeFrame': '5 years', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anovulation', 'Estrogen Loss', 'Hypoestrogenemia'], 'conditions': ['Hypothalamic Amenorrhea, Functional', 'Hypothalamic Amenorrhea', 'Functional Hypogonadotropic Hypogonadism']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "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.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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:\n\n * Estradiol: \\< 50pg/mL\n * LH: \\< 10 IU/mL\n * FSH: \\< 10 IU\n * Testosterone: 2 - 45 ng/dL\n * Free Testosterone: 0.1 - 6.4 pg/mL\n * FT4: 0.93 - 1.70 ng/dL\n * Prolactin: \\< 20 ng/mL\n * AMH: \\> 1 ng/mL\n * Urine or serum human chorionic gonadotropin: Negative\n* LH:FSH Ratio \\<1\n* No signs of male-like hair growth on the upper lip, chin, chest, abdomen, buttocks, or back\n* Does not have a diagnosis for secondary amenorrhea, including prolactinoma, PCOS, premature ovarian insufficiency, pituitary surgery, infection, or infarction\n* Premenopausal status determined by WISE criteria\n* Able to give informed consent\n* Able to read English\n\nExclusion Criteria:\n\n* Parturition/lactating in the last 6-12 months\n* Lack of consent'}, 'identificationModule': {'nctId': 'NCT06583408', 'acronym': 'REVEAL', 'briefTitle': 'The REgistry of Very Early Estrogen and AnovuLation', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'The REgistry of Very Early Estrogen and AnovuLation', 'orgStudyIdInfo': {'id': '24-000952'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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.', 'interventionNames': ['Other: Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)', 'Other: REVEAL Questionnaire']}], 'interventions': [{'name': 'Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)', 'type': 'OTHER', 'description': 'Subjects will complete the ASA food diary for 2 weekdays and 1 weekend day', 'armGroupLabels': ['Women with > 3 months amenorrhea']}, {'name': 'REVEAL Questionnaire', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Women with > 3 months amenorrhea']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chrisandra Shufelt, MD', 'role': 'CONTACT', 'email': 'DLREVEAL@exchange.mayo.edu'}, {'name': 'Stephanie Faubion, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chrisandra Shufelt, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chandler E. Palmer, MHA', 'role': 'CONTACT', 'email': 'palmer.chandler@mayo.edu', 'phone': '904-953-5438'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Chandler E. Palmer, MHA', 'role': 'CONTACT', 'email': 'palmer.chandler@mayo.edu', 'phone': '904-953-5438'}, {'name': 'Chrisandra L Shufelt, MD', 'role': 'CONTACT', 'email': 'DLREVEAL@exchange.mayo.edu', 'phone': '904 953-7224'}], 'overallOfficials': [{'name': 'Chrisandra Shufelt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair and Professor of Medicine', 'investigatorFullName': 'Chrisandra L. Shufelt, MD', 'investigatorAffiliation': 'Mayo Clinic'}}}}