Hypothyroidism Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Dose-conversion Study to Evaluate the Safety and Efficacy of Hormone Replacement Therapy With Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants Who Are Euthyroid on T4 Replacement Therapy
Verified date | May 2022 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the safe and effective dose conversion from levothyroxine (synthetic T4) therapy to Armour Thyroid therapy in participants who are on a stable dose of levothyroxine and have thyroid stimulating hormone (TSH) levels within the normal reference range.
Status | Completed |
Enrollment | 284 |
Est. completion date | June 22, 2021 |
Est. primary completion date | June 22, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Participants who have a diagnosis of primary hypothyroidism made = 12 months before study entry (Visit 1). - Be on continuous thyroid replacement therapy with synthetic T4 for primary hypothyroidism for at least 12 months immediately prior to the Screening Visit (Visit 1). - Be on a stable Food and Drug Administration (FDA)-approved daily dose of synthetic T4 for a minimum of 3 months prior to the Screening Visit (Visit 1). Must enter the study on the same stable dose. - Have euthyroid status indicated by at least 1 documented TSH value within normal reference range (0.45 - 4.12 mIU/L, inclusive) at a minimum of 6 weeks and maximum of 12 months prior to the Screening Visit (Visit 1). Also have a confirmed TSH value within the normal reference range drawn at the Screening Visit (Visit 1). - Male and female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period (35 days after last dose of study intervention). Exclusion Criteria: - Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion of Armour Thyroid or synthetic T4. - History of alcohol or other substance abuse within the previous 5 years. - Known or suspected allergy or intolerance to any ingredients of Armour Thyroid, including its excipients, levothyroxine (T4), other thyroid replacement medications, or pork products. - Have received active treatment with an investigational drug within 30 days or 5 half lives, whichever is longer, of Screening Visit (Visit 1). - Current enrollment in an investigational drug or device study or participation in such a study within 60 days of entry into this study. |
Country | Name | City | State |
---|---|---|---|
United States | Mountain Diabetes and Endocrine Center /ID# 235202 | Asheville | North Carolina |
United States | Atlanta Diabetes Associates /ID# 235032 | Atlanta | Georgia |
United States | Texas Diabetes and Endocrinology - Central Austin /ID# 237137 | Austin | Texas |
United States | Texas Diabetes and Endocrinology - South Austin /ID# 238071 | Austin | Texas |
United States | Central Research Associates /ID# 237950 | Birmingham | Alabama |
United States | Columbus Regional Research Ins /ID# 237199 | Columbus | Georgia |
United States | North TX Endocrine Center /ID# 237652 | Dallas | Texas |
United States | Research Institute Dallas /ID# 237655 | Dallas | Texas |
United States | Creekside Endocrine Associates PC /ID# 235866 | Denver | Colorado |
United States | Academy of Diabetes Thyroid and Endocrine /ID# 235870 | El Paso | Texas |
United States | The Center for Diabetes and Endocrine Care /ID# 235853 | Fort Lauderdale | Florida |
United States | NorCal Medical Research Inc /ID# 235210 | Greenbrae | California |
United States | Physician's East Endocrinology /ID# 235204 | Greenville | North Carolina |
United States | OnSite Clinical Solutions, LLC - Hickory /ID# 238023 | Hickory | North Carolina |
United States | Diabetes-Lipid Management & Research Center /ID# 235716 | Huntington Beach | California |
United States | Physicians Research Associates, LLC /ID# 238088 | Lawrenceville | Georgia |
United States | Kentucky Diabetes Endocrinology Center /ID# 235714 | Lexington | Kentucky |
United States | Atria Clinical Research /ID# 237986 | Little Rock | Arkansas |
United States | L-MARC Research Center /ID# 236701 | Louisville | Kentucky |
United States | Rainier Clinical Research Center LLC /ID# 235211 | Renton | Washington |
United States | Texas Diabetes & Endocrinology /ID# 235860 | Round Rock | Texas |
United States | Center for Excellence in Diabetes and Endocrinology /ID# 238120 | Sacramento | California |
United States | Diabetes & Glandular Disease Clinic P.A. /ID# 235894 | San Antonio | Texas |
United States | Care Access Research /ID# 238026 | Santa Clarita | California |
United States | MultiCare Institute for Research & Innovation /ID# 236022 | Spokane | Washington |
United States | Multicare Institute for Research and Innovation /ID# 236977 | Tacoma | Washington |
United States | San Fernando Valley Health Institute /ID# 238258 | Van Nuys | California |
United States | Metabolic Research Inst /ID# 236809 | West Palm Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Allergan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The percent of participants who are Sustained Thyroid-Stimulating Hormone (TSH) Responders | Participants whose TSH values are within the normal reference range among participants who received at least 1 dose of study intervention | Up to week 48 | |
Secondary | The percent of participants who are Titration TSH Responders | Participants whose TSH values are within the normal reference range among participants who received at least 1 dose of study intervention | Up to week 48 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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