Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

This study will include will include a Screening Period, double-blinded Titration Period (at least 18 weeks, up to 36 weeks), and a double-blinded Stabilization Period (12 weeks). Participants will be randomized to receive either their same dose of levothyroxine or an approximately, matching dose of Armour Thyroid, using a dose-conversion chart based on the United States Pharmacopeia (USP) Drug Information 2000, which states that 1 grain of Armour Thyroid is equivalent to 100 mcg of levothyroxine. During the Titration Period, Investigators will have the option to up-or down-titrate a participant's dose as needed based on the participant's TSH level (normal reference range 0.45 - 4.12 mIU/L, inclusive). At Week 18, if a participant's TSH levels are not within the normal reference range, the Investigator may up-or down-titrate the dose by continuing the Titration Period beyond Week 18 for up to a maximum of 3 additional titrations at 6-week intervals. Participants whose TSH levels have not normalized after the maximum 3 additional titrations will not enter the Stabilization Period. At the end of the Titration Period, participants with TSH levels within normal reference range may enter the Stabilization Period. Depending on whether a participant requires additional dose titration after the Week 18 visit, the Stabilization Period may end at Week 30, 36, 42, or 48. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04124705
Study type Interventional
Source Allergan
Contact
Status Completed
Phase Phase 2
Start date October 11, 2019
Completion date June 22, 2021

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05975866 - The Effects of an Anti-inflammatory Diet With or Without Curcumin Supplementation on Anthropometric Measurements, Concentrations of Thyroid Hormones, Anti-TPO, and Systemic Inflammation in Plasma and NFK-B in Peripheral Blood Mononuclear Cells in Patients With Hashimato N/A
Not yet recruiting NCT05334771 - Early Detection of Endolymphatic Hydrops in Hypothyroid Patients
Withdrawn NCT01707056 - The Effect of Coffee on the Absorption of Thyroid Hormone in Patients With Thyroid Carcinoma N/A
Completed NCT00094237 - Subclinical Thyroid Dysfunction and Risk of Myocardial Infarction and Stroke N/A
Recruiting NCT06015620 - Comorbidities Resolution After MGB Surgery and Change in Body Composition
Completed NCT03612908 - TSHβX1 and D2 THR92ALA in Pregnancy
Completed NCT04782856 - Energy Metabolism in Thyroidectomized Patients Phase 2
Completed NCT01921452 - Study to Verify Clinical Utility of Point-of-Care (POC) Thyroid Stimulating Hormone (TSH) Test Kits as Compared to Third Generation TSH Test Kit Phase 4
Completed NCT01197183 - Observational Study With Prospective and/or Retrospective Follow-up, Without Modifying Patient Treatment and Follow-up Practices for the Initial Treatment of Hypothyroidism in France N/A
Recruiting NCT05247476 - Type 2 Deiodinase Gene Polymorphism and the Treatment of Hypothyroidism Caused by Thyroidectomy in Thyroid Cancer Patients. Phase 4
Recruiting NCT03754621 - Upper Limit for TSH of First and Second Trimester Pregnancy in Turkey
Completed NCT02959827 - Iodinated Contrast Agents and Risk of Hypothyroidism in Young Children in the United States
Withdrawn NCT02577367 - Mean Percentage of Levothyroxine Dosage Increase in Patients With Hypothyroidism Started on Enteral Feeding Phase 4
Completed NCT04098991 - Improving White Matter Integrity With Thyroid Hormone
Not yet recruiting NCT03257566 - Hypothyroidism in Patients With Type 1 Diabetes N/A
Terminated NCT02567877 - Is Levothyroxine Alone Adequate Thyroid Hormone Replacement?
Completed NCT02280330 - Iodine Status of Preschoolers Given Micronutrient Powder for 6 Months Phase 4
Completed NCT00403390 - Generic vs. Name-Brand Levothyroxine N/A
Not yet recruiting NCT06096454 - Effect of Life Style Modification and Metformin on Hypothyroidism With Insulin Resistance Phase 4
Completed NCT04528225 - A Prospective Study of Hypothyroidism After Radiotherapy for Breast Cancer