A Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants
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|ClinicalTrials.gov Identifier: NCT04124705|
Recruitment Status : Completed
First Posted : October 11, 2019
Last Update Posted : May 13, 2022
|Condition or disease||Intervention/treatment||Phase|
|Hypothyroidism Thyroid Disease Euthyroid Thyroid Gland Thyroid Hormones||Drug: Armour® Thyroid Drug: Levothyroxine||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||284 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||October 11, 2019|
|Actual Primary Completion Date :||June 22, 2021|
|Actual Study Completion Date :||June 22, 2021|
Experimental: Armour® Thyroid
Participants were randomized to receive Armour Thyroid at a dose corresponding to their pre-randomized dose of synthetic T4. During the first 18 to 36 weeks (titration period) the dose of Armour Thyroid could be titrated based on levels of thyroid stimulating hormone (TSH), in order to achieve TSH levels within the normal reference range (0.45 - 4.12 mIU/L, inclusive). Once TSH levels were within the normal reference range, participants continued to receive a stable dose of Armour Thyroid for an additional 12 weeks (stabilization period).
Drug: Armour® Thyroid
Administered orally once a day. the daily dose could range from 1/4 - 2 grains.
Active Comparator: Levothyroxine
Participants were randomized to receive levothyroxine at their pre-randomized dose. During the first 18 to 36 weeks (titration period) the dose of levothyroxine could be titrated based on levels of TSH in order to achieve TSH levels within the normal reference range (0.45-4.12 mIU/L, inclusive). Once TSH levels were within the normal reference range, participants continued to receive a stable dose of levothyroxine for an additional 12 weeks (stabilization period).
Administered orally once a day; the daily dose could range from 25- 200 µg.
Other Name: Synthetic T4
- The percent of participants who are Sustained Thyroid-Stimulating Hormone (TSH) Responders [ Time Frame: Up to week 48 ]Participants whose TSH values are within the normal reference range among participants who received at least 1 dose of study intervention
- The percent of participants who are Titration TSH Responders [ Time Frame: Up to week 48 ]Participants whose TSH values are within the normal reference range among participants who received at least 1 dose of study intervention
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124705
|Study Director:||ALLERGAN INC.||Allergan|