protocolSection identificationModule nctId: NCT06345339, orgStudyIdInfo id: M21-341, briefTitle: A Study to Assess the Safety and Efficacy of Oral Armour Thyroid Compared to Synthetic T4 for the Treatment of Primary Hypothyroidism in Adult Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-26, primaryCompletionDateStruct date: 2028-06-03, completionDateStruct date: 2028-06-03, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: AbbVie, class: INDUSTRY, descriptionModule briefSummary: This study will evaluate the efficacy and safety of Armour Thyroid treatment compared with synthetic T4 in subjects who have primary hypothyroidism and are currently stabilized (i.e., in-range thyroid-stimulating hormone \[TSH\]) on synthetic T4 treatment. This study will also therefore evaluate the efficacy and safety of dose conversion from synthetic T4 therapy to Armour Thyroid therapy., conditionsModule conditions: Hypothyroidism, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 2800, type: ESTIMATED, armsInterventionsModule interventions name: Armour Thyroid, interventions name: Levothyroxine, outcomesModule primaryOutcomes measure: Percentage of Participants who Achieve Thyroid-Stimulating Hormone (TSH) Response, primaryOutcomes measure: Number of Participants with Adverse Events (AEs), secondaryOutcomes measure: Percentage of Participants who Achieve TSH Response, secondaryOutcomes measure: Number of Participants Needing Altered Dose Conversion from Synthetic T4 to Armour Thyroid, secondaryOutcomes measure: Frequency of Dose Titrations During the Double-Blind (DB) Period Among Participants who Achieved TSH Response at the End of the DB Period, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Diagnamics Inc. /ID# 262680, status: RECRUITING, city: Encinitas, state: California, zip: 92024, country: United States, geoPoint lat: 33.03699, lon: -117.29198, locations facility: NorCal Medical Research /ID# 256512, status: RECRUITING, city: Greenbrae, state: California, zip: 94904, country: United States, geoPoint lat: 37.94854, lon: -122.5247, locations facility: West Orange Endocrinology /ID# 256139, status: RECRUITING, city: Ocoee, state: Florida, zip: 34761-4547, country: United States, geoPoint lat: 28.56917, lon: -81.54396, locations facility: Endocrine Research Solutions /ID# 256784, status: RECRUITING, city: Roswell, state: Georgia, zip: 30076, country: United States, contacts name: Site Coordinator, role: CONTACT, phone: 678-878-4750, geoPoint lat: 34.02316, lon: -84.36159, locations facility: West Broadway Clinic /ID# 256756, status: RECRUITING, city: Council Bluffs, state: Iowa, zip: 51501-3822, country: United States, geoPoint lat: 41.26194, lon: -95.86083, locations facility: L-MARC Research Center /ID# 255733, status: RECRUITING, city: Louisville, state: Kentucky, zip: 40213-1014, country: United States, geoPoint lat: 38.25424, lon: -85.75941, locations facility: Physician's East Endocrinology /ID# 256491, status: RECRUITING, city: Greenville, state: North Carolina, zip: 27834, country: United States, geoPoint lat: 35.61266, lon: -77.36635, locations facility: Diabetes and Endocrinology Associates of Stark County Inc /ID# 256751, status: RECRUITING, city: Canton, state: Ohio, zip: 44718, country: United States, geoPoint lat: 40.79895, lon: -81.37845, locations facility: Lynn Institute of Norman /ID# 256785, status: RECRUITING, city: Norman, state: Oklahoma, zip: 73072, country: United States, geoPoint lat: 35.22257, lon: -97.43948, locations facility: Lynn Institute of Oklahoma City /ID# 263141, status: RECRUITING, city: Oklahoma City, state: Oklahoma, zip: 73112, country: United States, geoPoint lat: 35.46756, lon: -97.51643, locations facility: Texas Diabetes and Endocrinology - Central Austin /ID# 255728, status: RECRUITING, city: Austin, state: Texas, zip: 78731, country: United States, contacts name: Site Coordinator, role: CONTACT, phone: 512-334-3505, geoPoint lat: 30.26715, lon: -97.74306, locations facility: Texas Diabetes and Endocrinology - South Austin /ID# 255723, status: RECRUITING, city: Austin, state: Texas, zip: 78749, country: United States, geoPoint lat: 30.26715, lon: -97.74306, locations facility: North TX Endocrine Center /ID# 255737, status: RECRUITING, city: Dallas, state: Texas, zip: 75231, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Diabetes and Thyroid Center of Ft. Worth /ID# 256781, status: RECRUITING, city: Fort Worth, state: Texas, zip: 76132, country: United States, geoPoint lat: 32.72541, lon: -97.32085, locations facility: Juno Research /ID# 259238, status: RECRUITING, city: Houston, state: Texas, zip: 77040-5059, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Consano Clinical Research, LLC /ID# 256138, status: RECRUITING, city: Shavano Park, state: Texas, zip: 78231, country: United States, contacts name: Site Coordinator, role: CONTACT, phone: 210.291.3797, geoPoint lat: 29.58495, lon: -98.55252, locations facility: Texas Valley Clinical Research /ID# 261476, status: RECRUITING, city: Weslaco, state: Texas, zip: 78596, country: United States, geoPoint lat: 26.15952, lon: -97.99084, hasResults: False