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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
284
Administered orally once a day. the daily dose could range from 1/4 - 2 grains.
Administered orally once a day; the daily dose could range from 25- 200 µg.
Percentage of Participants With a Sustained TSH Response
Sustained TSH response is defined as TSH values that are within the normal reference range of 0.45 to 4.12 mIU/L, inclusive, at both the end of Titration Period and the end of the Stabilization Period.
Time frame: End of the titration period (Week 18, 24, 30, or 36) and end of the stabilization period (Week 30, 36, 42, or 48, depending on the length of the titration period).
Percentage of Participants With a Titration TSH Response
Titration TSH Response is defined as having a TSH value within the normal reference range of 0.45 to 4.12 mIU/L, inclusive, at the end of the Titration Period.
Time frame: End of the titration period (Week 18, 24, 30, or 36)
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Sponsor Site /ID# 237950
Birmingham, Alabama, United States
Sponsor Site /ID# 237986
Little Rock, Arkansas, United States
Sponsor Site /ID# 235210
Greenbrae, California, United States
Sponsor Site /ID# 235716
Huntington Beach, California, United States
Sponsor Site /ID# 238120
Sacramento, California, United States
Sponsor Site /ID# 238026
Santa Clarita, California, United States
Sponsor Site /ID# 238258
Van Nuys, California, United States
Sponsor Site/ID# 235866
Denver, Colorado, United States
Sponsor Site /ID# 235853
Fort Lauderdale, Florida, United States
Sponsor Site /ID# 236809
West Palm Beach, Florida, United States
...and 18 more locations