Back to resultsA Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants
Primary Purpose
Hypothyroidism, Thyroid Disease, Euthyroid
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Armour® Thyroid
Levothyroxine
Sponsored by
About this trial
This is an interventional treatment trial for Hypothyroidism
Eligibility Criteria
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.
Sites / Locations
- Central Research Associates /ID# 237950
- Atria Clinical Research /ID# 237986
- NorCal Medical Research Inc /ID# 235210
- Diabetes-Lipid Management & Research Center /ID# 235716
- Center for Excellence in Diabetes and Endocrinology /ID# 238120
- Care Access Research /ID# 238026
- San Fernando Valley Health Institute /ID# 238258
- Creekside Endocrine Associates PC /ID# 235866
- The Center for Diabetes and Endocrine Care /ID# 235853
- Metabolic Research Inst /ID# 236809
- Atlanta Diabetes Associates /ID# 235032
- Columbus Regional Research Ins /ID# 237199
- Physicians Research Associates, LLC /ID# 238088
- Kentucky Diabetes Endocrinology Center /ID# 235714
- L-MARC Research Center /ID# 236701
- Mountain Diabetes and Endocrine Center /ID# 235202
- Physician's East Endocrinology /ID# 235204
- OnSite Clinical Solutions, LLC - Hickory /ID# 238023
- Texas Diabetes and Endocrinology - Central Austin /ID# 237137
- Texas Diabetes and Endocrinology - South Austin /ID# 238071
- North TX Endocrine Center /ID# 237652
- Research Institute Dallas /ID# 237655
- Academy of Diabetes Thyroid and Endocrine /ID# 235870
- Texas Diabetes & Endocrinology /ID# 235860
- Diabetes & Glandular Disease Clinic P.A. /ID# 235894
- Rainier Clinical Research Center LLC /ID# 235211
- MultiCare Institute for Research & Innovation /ID# 236022
- Multicare Institute for Research and Innovation /ID# 236977
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Armour® Thyroid
Levothyroxine
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04124705
Brief Title
A Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 11, 2019 (Actual)
Primary Completion Date
June 22, 2021 (Actual)
Study Completion Date
June 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothyroidism, Thyroid Disease, Euthyroid, Thyroid Gland, Thyroid Hormones
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
284 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Armour® Thyroid
Arm Type
Experimental
Arm Description
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).
Arm Title
Levothyroxine
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Armour® Thyroid
Other Intervention Name(s)
Desiccated thyroid extract, AGN-204771
Intervention Description
Administered orally once a day. the daily dose could range from 1/4 - 2 grains.
Intervention Type
Drug
Intervention Name(s)
Levothyroxine
Other Intervention Name(s)
Synthetic T4
Intervention Description
Administered orally once a day; the daily dose could range from 25- 200 µg.
Primary Outcome Measure Information:
Title
The percent of participants who are Sustained Thyroid-Stimulating Hormone (TSH) Responders
Description
Participants whose TSH values are within the normal reference range among participants who received at least 1 dose of study intervention
Time Frame
Up to week 48
Secondary Outcome Measure Information:
Title
The percent of participants who are Titration TSH Responders
Description
Participants whose TSH values are within the normal reference range among participants who received at least 1 dose of study intervention
Time Frame
Up to week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALLERGAN INC.
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Central Research Associates /ID# 237950
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Atria Clinical Research /ID# 237986
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72209-7040
Country
United States
Facility Name
NorCal Medical Research Inc /ID# 235210
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Diabetes-Lipid Management & Research Center /ID# 235716
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Center for Excellence in Diabetes and Endocrinology /ID# 238120
City
Sacramento
State/Province
California
ZIP/Postal Code
95821-2123
Country
United States
Facility Name
Care Access Research /ID# 238026
City
Santa Clarita
State/Province
California
ZIP/Postal Code
91321
Country
United States
Facility Name
San Fernando Valley Health Institute /ID# 238258
City
Van Nuys
State/Province
California
ZIP/Postal Code
91405-3605
Country
United States
Facility Name
Creekside Endocrine Associates PC /ID# 235866
City
Denver
State/Province
Colorado
ZIP/Postal Code
80246
Country
United States
Facility Name
The Center for Diabetes and Endocrine Care /ID# 235853
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33312
Country
United States
Facility Name
Metabolic Research Inst /ID# 236809
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Atlanta Diabetes Associates /ID# 235032
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Columbus Regional Research Ins /ID# 237199
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Physicians Research Associates, LLC /ID# 238088
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Kentucky Diabetes Endocrinology Center /ID# 235714
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
L-MARC Research Center /ID# 236701
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213-1014
Country
United States
Facility Name
Mountain Diabetes and Endocrine Center /ID# 235202
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Physician's East Endocrinology /ID# 235204
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
OnSite Clinical Solutions, LLC - Hickory /ID# 238023
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Texas Diabetes and Endocrinology - Central Austin /ID# 237137
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Texas Diabetes and Endocrinology - South Austin /ID# 238071
City
Austin
State/Province
Texas
ZIP/Postal Code
78749
Country
United States
Facility Name
North TX Endocrine Center /ID# 237652
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Research Institute Dallas /ID# 237655
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Academy of Diabetes Thyroid and Endocrine /ID# 235870
City
El Paso
State/Province
Texas
ZIP/Postal Code
79935
Country
United States
Facility Name
Texas Diabetes & Endocrinology /ID# 235860
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Diabetes & Glandular Disease Clinic P.A. /ID# 235894
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Rainier Clinical Research Center LLC /ID# 235211
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
MultiCare Institute for Research & Innovation /ID# 236022
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Multicare Institute for Research and Innovation /ID# 236977
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing, please refer to the link below.
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
http://www.AllerganClinicalTrials.com
Description
Additional information on study locations near you may be found at AllerganClinicalTrials.com.
Learn more about this trial
A Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants
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