Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-27 @ 11:26 AM
Study NCT ID:
NCT05607303
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-04
First Post:
2022-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Hormones on Frequency of Headache and Brain Structure and Function in Puberty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-03', 'studyFirstSubmitDate': '2022-10-31', 'studyFirstSubmitQcDate': '2022-10-31', 'lastUpdatePostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in frequency of headache.', 'timeFrame': '1 year', 'description': 'Measured by headache count from daily headache diary.'}], 'secondaryOutcomes': [{'measure': 'Change in amygdala structure.', 'timeFrame': '1 year', 'description': 'Amygdala volume as measured on MRI.'}, {'measure': 'Change in resting state functional connectivity pattern.', 'timeFrame': '1 year', 'description': 'Measured by proportion of between-module connectivity patterns vs. within-module connectivity patterns.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Headache', 'Gender Identity']}, 'descriptionModule': {'briefSummary': 'With a rising population of transgender adults and youth, there is a need for more research to meet the needs of this community. Transfemale (MTF) youth (male sex, female gender identity) who begin clinical Gender Affirming Hormone Therapy (GAHT) with estrogen may be at a higher risk for headache since estrogen has been linked to headache in cisgender females (female sex, female gender identity). This research hopes to learn more about headache in MTF youth.', 'detailedDescription': 'MTF youth who will begin estrogen clinically will be enrolled in the study and will be seen twice, once before starting estrogen and then one year after beginning estrogen. Cisgender males (male sex, male gender identity) will also be enrolled as a control group and will be seen once at the beginning of the study and then once a year later. The researchers will track how often youth have headaches during this time to see if it is different between groups. In a subset of the youth enrolled, an MRI will be completed to also look at brain structure and function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '9 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population is limited to transgender females (male sex, female gender identity) for the case population and cisgender males (male sex, male gender identity) for the purposes of the study analysis as outlined in the protocol.', 'genderDescription': 'Transfemale (MTF) youth (male sex, female gender identity) and cisgender males (male sex, male gender identity) will be recruited for the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor MTF youth (cases):\n\n* Identify as MTF\n* Age 11-20 years at the time of enrollment\n* Plan to start estrogen clinically in \\< 6 months\n\nFor cisgender male youth (controls):\n\n* Identify as cisgender male\n* Age 9-20 years at the time of enrollment\n* No diagnosis of Klinefelter Syndrome (XXY)\n\nExclusion Criteria:\n\n* Cognitive, or psychiatric impairment resulting in inability to tolerate the study procedures not including depression or anxiety\n* Known history of stroke, multiple sclerosis, or other serious neurologic condition\n\n * MRI-specific exclusion criteria (Weight \\> 500 lbs, claustrophobia, metal in body)'}, 'identificationModule': {'nctId': 'NCT05607303', 'briefTitle': 'Effect of Hormones on Frequency of Headache and Brain Structure and Function in Puberty', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Effect of Hormones on Frequency of Headache and Brain Structure and Function in Puberty', 'orgStudyIdInfo': {'id': '20-1824'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'MTF youth who will begin taking estrogen clinically in \\< 6 months with or without headache', 'interventionNames': ['Other: Clinical estrogen therapy']}, {'label': 'Controls', 'description': 'Cisgender males with or without headache'}], 'interventions': [{'name': 'Clinical estrogen therapy', 'type': 'OTHER', 'description': "No research interventions will be used as a part of the study since the research is observational. Estrogen treatment will be prescribed and followed by participant's clinical physician.", 'armGroupLabels': ['Cases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Jennifer Hranilovich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Colorado"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}