A Study Evaluating the Safety and Efficacy of Hormone Replacement Therapy With ST-1891 Compared to Levothyroxine in Patients With Primary Hypothyroidism
NCT ID: NCT05412979
Last Updated: 2024-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
490 participants
INTERVENTIONAL
2022-04-29
2023-10-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ST-1891
ST-1891
ST-1891
Levothyroxine
Levothyroxine
Levothyroxine
Interventions
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ST-1891
ST-1891
Levothyroxine
Levothyroxine
Eligibility Criteria
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Inclusion Criteria
* On continuous thyroid replacement therapy with levothyroxine for at least 12 months immediately prior to Screening
* On a stable daily dose of levothyroxine for the 3 months prior to Screening
* Willing to give written informed consent for the Study
Exclusion Criteria
* Female patients who are pregnant or are breastfeeding starting 30 days prior to Screening
* Anticipated initiation or change in concomitant medications
* Concomitant use of prohibited medications
* Currently participating in another clinical study or have received active treatment with an investigational drug within 30 days or 5 half-lives of the investigational drug of Screening, whichever is longer
18 Years
75 Years
ALL
No
Sponsors
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Sention Therapeutics, LLC
INDUSTRY
Responsible Party
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Locations
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Sention Investigational Site
Greenbrae, California, United States
Sention Investigational Site
Newhall, California, United States
Sention Investigational Site
Denver, Colorado, United States
Sention Investigational Site
Fort Lauderdale, Florida, United States
Sention Investigational Site
Jacksonville, Florida, United States
Sention Investigational Site
New Port Richey, Florida, United States
Sention Investigational Site
Palm Harbor, Florida, United States
Sention Investigational Site
Atlanta, Georgia, United States
Sention Investigational Site
Lawrenceville, Georgia, United States
Sention Investigational Site
Roswell, Georgia, United States
Sention Investigational Site
Evergreen Park, Illinois, United States
Sention Investigational Site
Newburgh, Indiana, United States
Sention Investigational Site
South Bend, Indiana, United States
Sention Investigational Site
Ankeny, Iowa, United States
Sention Investigational Site
Louisville, Kentucky, United States
Sention Investigational Site
Dearborn, Michigan, United States
Sention Investigational Site
Chesterfield, Missouri, United States
Sention Investigational Site
Jefferson City, Missouri, United States
Sention Investigational Site
Staten Island, New York, United States
Sention Investigational Site
Cary, North Carolina, United States
Sention Investigational Site
Greenville, North Carolina, United States
Sention Investigational Site
Hickory, North Carolina, United States
Sention Investigational Site
Morehead City, North Carolina, United States
Sention Investigational Site
Raleigh, North Carolina, United States
Sention Investigational Site
Rocky Mount, North Carolina, United States
Sention Investigational Site
Salisbury, North Carolina, United States
Sention Investigational Site
Wilmington, North Carolina, United States
Sention Investigational Site
Mt. Pleasant, South Carolina, United States
Sention Investigational Site
Bristol, Tennessee, United States
Sention Investigational Site
Chattanooga, Tennessee, United States
Sention Investigational Site
Memphis, Tennessee, United States
Sention Investigational Site
Austin, Texas, United States
Sention Investigational Site
Austin, Texas, United States
Sention Investigational Site
Benbrook, Texas, United States
Sention Investigational Site
Live Oak, Texas, United States
Sention Investigational Site
Round Rock, Texas, United States
Sention Investigational Site
Webster, Texas, United States
Sention Investigational Site
Virginia Beach, Virginia, United States
Sention Investigational Site
Renton, Washington, United States
Countries
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Other Identifiers
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ST-1891-201
Identifier Type: -
Identifier Source: org_study_id
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