nctId: NCT06345339 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 overallStatus: RECRUITING date: 2024-04-26 date: 2028-06-03 date: 2028-06-03 date: 2024-04-03 date: 2024-04-29 name: AbbVie class: INDUSTRY 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. conditions: Hypothyroidism studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 2800 type: ESTIMATED name: Armour Thyroid name: Levothyroxine measure: Percentage of Participants who Achieve Thyroid-Stimulating Hormone (TSH) Response measure: Number of Participants with Adverse Events (AEs) measure: Percentage of Participants who Achieve TSH Response measure: Number of Participants Needing Altered Dose Conversion from Synthetic T4 to Armour Thyroid measure: Frequency of Dose Titrations During the Double-Blind (DB) Period Among Participants who Achieved TSH Response at the End of the DB Period sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Diagnamics Inc. /ID# 262680 status: RECRUITING city: Encinitas state: California zip: 92024 country: United States lat: 33.03699 lon: -117.29198 facility: NorCal Medical Research /ID# 256512 status: RECRUITING city: Greenbrae state: California zip: 94904 country: United States lat: 37.94854 lon: -122.5247 facility: West Orange Endocrinology /ID# 256139 status: RECRUITING city: Ocoee state: Florida zip: 34761-4547 country: United States lat: 28.56917 lon: -81.54396 facility: Endocrine Research Solutions /ID# 256784 status: RECRUITING city: Roswell state: Georgia zip: 30076 country: United States name: Site Coordinator role: CONTACT phone: 678-878-4750 lat: 34.02316 lon: -84.36159 facility: West Broadway Clinic /ID# 256756 status: RECRUITING city: Council Bluffs state: Iowa zip: 51501-3822 country: United States lat: 41.26194 lon: -95.86083 facility: L-MARC Research Center /ID# 255733 status: RECRUITING city: Louisville state: Kentucky zip: 40213-1014 country: United States lat: 38.25424 lon: -85.75941 facility: Physician's East Endocrinology /ID# 256491 status: RECRUITING city: Greenville state: North Carolina zip: 27834 country: United States lat: 35.61266 lon: -77.36635 facility: Diabetes and Endocrinology Associates of Stark County Inc /ID# 256751 status: RECRUITING city: Canton state: Ohio zip: 44718 country: United States lat: 40.79895 lon: -81.37845 facility: Lynn Institute of Norman /ID# 256785 status: RECRUITING city: Norman state: Oklahoma zip: 73072 country: United States lat: 35.22257 lon: -97.43948 facility: Lynn Institute of Oklahoma City /ID# 263141 status: RECRUITING city: Oklahoma City state: Oklahoma zip: 73112 country: United States lat: 35.46756 lon: -97.51643 facility: Texas Diabetes and Endocrinology - Central Austin /ID# 255728 status: RECRUITING city: Austin state: Texas zip: 78731 country: United States name: Site Coordinator role: CONTACT phone: 512-334-3505 lat: 30.26715 lon: -97.74306 facility: Texas Diabetes and Endocrinology - South Austin /ID# 255723 status: RECRUITING city: Austin state: Texas zip: 78749 country: United States lat: 30.26715 lon: -97.74306 facility: North TX Endocrine Center /ID# 255737 status: RECRUITING city: Dallas state: Texas zip: 75231 country: United States lat: 32.78306 lon: -96.80667 facility: Diabetes and Thyroid Center of Ft. Worth /ID# 256781 status: RECRUITING city: Fort Worth state: Texas zip: 76132 country: United States lat: 32.72541 lon: -97.32085 facility: Juno Research /ID# 259238 status: RECRUITING city: Houston state: Texas zip: 77040-5059 country: United States lat: 29.76328 lon: -95.36327 facility: Consano Clinical Research, LLC /ID# 256138 status: RECRUITING city: Shavano Park state: Texas zip: 78231 country: United States name: Site Coordinator role: CONTACT phone: 210.291.3797 lat: 29.58495 lon: -98.55252 facility: Texas Valley Clinical Research /ID# 261476 status: RECRUITING city: Weslaco state: Texas zip: 78596 country: United States lat: 26.15952 lon: -97.99084 hasResults: False