Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-01-03 @ 9:31 PM
Study NCT ID:
NCT03740204
Status:
RECRUITING
Last Update Posted:
2025-05-06
First Post:
2018-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Estrogen in the Neurobiology of Eating Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D000568', 'term': 'Amenorrhea'}, {'id': 'D000856', 'term': 'Anorexia Nervosa'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-02', 'studyFirstSubmitDate': '2018-11-05', 'studyFirstSubmitQcDate': '2018-11-09', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in inhibition-switching performance on the Delis-Kaplan Executive Function System Color-Word Interference Test (D-KEFS CWIT) with 17-β estradiol versus placebo', 'timeFrame': 'Baseline to 8 weeks'}, {'measure': 'Change in Temporal Experience of Pleasure Scale (TEPS) Consummatory Pleasure score (Range: 8-48; direction: Higher values indicate more pronounced consummatory pleasure/better outcome) with 17-β estradiol versus placebo', 'timeFrame': 'Baseline to 8 weeks'}, {'measure': 'Change in delay discounting parameter k using the Monetary Choice Questionnaire with 17-β estradiol versus placebo', 'timeFrame': 'Baseline to 8 weeks'}, {'measure': 'Change in Eating Disorder Inventory-3 (EDI-3) Body Dissatisfaction score (Range: 0-36; direction: Higher values indicate more pronounced body dissatisfaction/worse outcome) with 17-β estradiol versus placebo', 'timeFrame': 'Baseline to 12 weeks'}, {'measure': 'Change in EDI-3 Drive for Thinness score (Range: 0-28; direction: Higher values indicate more pronounced drive for thinness/worse outcome) with 17-β estradiol versus placebo', 'timeFrame': 'Baseline to 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in functional magnetic resonance imaging (fMRI) activation of the dorsolateral prefrontal cortex (DLPFC) and anterior cingulate cortex (ACC) during a task switching paradigm with 17-β estradiol versus placebo', 'timeFrame': 'Baseline to 8 weeks'}, {'measure': 'Change in fMRI activation of the ventromedial prefrontal cortex (VMPFC) and ventral striatum in response to reward receipt with 17-β estradiol versus placebo', 'timeFrame': 'Baseline to 8 weeks'}, {'measure': 'Change in fMRI activation of the VMPFC and ventral striatum during delay discounting with 17-β estradiol versus placebo', 'timeFrame': 'Baseline to 8 weeks'}, {'measure': 'Change in the Eating Disorder Examination (EDE) Dietary Restraint subscale (Range: 0-6; direction: Higher values indicate more pronounced dietary restraint/worse outcome) with 17-β estradiol versus placebo', 'timeFrame': 'Baseline to 12 weeks'}, {'measure': 'Change in caloric intake by 4-day food diary with 17-β estradiol versus placebo', 'timeFrame': 'Baseline to 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adolescent', 'Amenorrhea', 'Anorexia Nervosa', 'Cognitive Flexibility', 'Dietary Restriction', 'Eating Disorders', 'Estrogen', 'Excessive Exercise', 'Females', 'Hypoestrogenemia', 'Reward'], 'conditions': ['Eating Disorders', 'Hypoestrogenemia']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double blind, placebo-controlled study of the effects of transdermal estradiol versus placebo on cognitive flexibility, reward processing, and eating disorder pathology in hypoestrogenemic female adolescents and young adults (ages 14-35 years) with an eating disorder characterized by extreme dietary restriction and/or excessive exercise. Subjects will be randomized 1:1 to 12 weeks of transdermal estradiol with cyclic progesterone or placebo patches and cyclic placebo pills. Study visits include a screening visit to determine eligibility and visits at baseline, 8 weeks, and 12 weeks. Study procedures comprise behavioral, neuroimaging, and endocrine assessments.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Female\n* 14-35 years\n* Bone age ≥13.5 years (applicable only for participants \\<16 years)\n* Clinically significant eating disorder characterized by restriction and/or excessive exercise and high drive for thinness\n* Hypoestrogenemia: Oligo-amenorrhea defined as lack of menses for ≥3 months within a 6-month period of oligomenorrhea (cycle length ≥5 weeks) or absence of menses at \\>15 years if premenarchal or low estradiol levels evaluated by the study physician\n* Low or normal weight defined by a body mass index that is \\<85th percentile for 14-18 year olds and a body mass index \\<25 kg/m2 for adults\n\nExclusion criteria:\n\n* Suicidal ideation where outpatient treatment is determined unsafe by study clinician\n* Other causes of oligo-amenorrhea, unless a study clinician determines that missed menstrual periods are more likely a consequence of restrictive eating\n* Medications that contain estrogen ± progesterone within the past 3 months\n* Levonorgestrel-releasing intrauterine device if subject is unable to provide two to three weekly blood samples for estradiol of if estradiol levels are determined to be too high by study doctor\n* Neurological or psychiatric disorders that may impact neural circuitry of interest\n* Lifetime history of seizure disorder or electroconvulsive therapy\n* Pregnancy/breastfeeding\n* Gastrointestinal tract surgery\n* Contraindications to estrogen use\n* Any other significant illness or condition that the investigator determines could interfere with study participation or safety or put the subject at any unnecessary risk'}, 'identificationModule': {'nctId': 'NCT03740204', 'briefTitle': 'The Role of Estrogen in the Neurobiology of Eating Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'The Role of Estrogen in the Neurobiology of Eating Disorders: A Study of Cognitive Flexibility and Reward in Eating Disorders', 'orgStudyIdInfo': {'id': '1R01MH116205', 'link': 'https://reporter.nih.gov/quickSearch/1R01MH116205', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '17-β estradiol with cyclic progesterone', 'interventionNames': ['Drug: 17-β estradiol transdermal patches with cyclic progesterone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo patch and pill']}], 'interventions': [{'name': '17-β estradiol transdermal patches with cyclic progesterone', 'type': 'DRUG', 'description': '17-β estradiol transdermal patches (100 mcg 17-β estradiol/day) with cyclic progesterone (200 mg micronized progesterone daily for 12 days every month)', 'armGroupLabels': ['17-β estradiol with cyclic progesterone']}, {'name': 'Placebo patch and pill', 'type': 'DRUG', 'description': 'Placebo patch and pill', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Madhusmita Misra, M.D., M.P.H.', 'role': 'CONTACT', 'email': 'mmisra@mgh.harvard.edu', 'phone': '617-726-5790'}, {'name': 'Kamryn Eddy, Ph.D.', 'role': 'CONTACT', 'email': 'keddy@mgh.harvard.edu', 'phone': '617-724-0799'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Madhusmita Misra, M.D., M.P.H.', 'role': 'CONTACT', 'email': 'abp6bd@uvahealth.edu', 'phone': '617-726-5790'}, {'name': 'Kamryn Eddy, Ph.D.', 'role': 'CONTACT', 'email': 'keddy@mgh.harvard.edu', 'phone': '617-724-1744'}], 'overallOfficials': [{'name': 'Madhusmita Misra, M.D., M.P.H.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Division Chief, Pediatric Endocrinology', 'investigatorFullName': 'Madhusmita Misra', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}