A Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants

Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT04124705
Collaborator
(none)
284
28
2
20.4
10.1
0.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
284 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 :
Oct 11, 2019
Actual Primary Completion Date :
Jun 22, 2021
Actual Study Completion Date :
Jun 22, 2021

Arms and Interventions

Arm Intervention/Treatment
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.
Other Names:
  • Desiccated thyroid extract
  • AGN-204771
  • 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).

    Drug: Levothyroxine
    Administered orally once a day; the daily dose could range from 25- 200 µg.
    Other Names:
  • Synthetic T4
  • Outcome Measures

    Primary Outcome Measures

    1. The percent of participants who are Sustained Thyroid-Stimulating Hormone (TSH) Responders [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

    Secondary Outcome Measures

    1. The percent of participants who are Titration TSH Responders [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Central Research Associates /ID# 237950 Birmingham Alabama United States 35205
    2 Atria Clinical Research /ID# 237986 Little Rock Arkansas United States 72209-7040
    3 NorCal Medical Research Inc /ID# 235210 Greenbrae California United States 94904
    4 Diabetes-Lipid Management & Research Center /ID# 235716 Huntington Beach California United States 92648
    5 Center for Excellence in Diabetes and Endocrinology /ID# 238120 Sacramento California United States 95821-2123
    6 Care Access Research /ID# 238026 Santa Clarita California United States 91321
    7 San Fernando Valley Health Institute /ID# 238258 Van Nuys California United States 91405-3605
    8 Creekside Endocrine Associates PC /ID# 235866 Denver Colorado United States 80246
    9 The Center for Diabetes and Endocrine Care /ID# 235853 Fort Lauderdale Florida United States 33312
    10 Metabolic Research Inst /ID# 236809 West Palm Beach Florida United States 33401
    11 Atlanta Diabetes Associates /ID# 235032 Atlanta Georgia United States 30318
    12 Columbus Regional Research Ins /ID# 237199 Columbus Georgia United States 31904
    13 Physicians Research Associates, LLC /ID# 238088 Lawrenceville Georgia United States 30046
    14 Kentucky Diabetes Endocrinology Center /ID# 235714 Lexington Kentucky United States 40503
    15 L-MARC Research Center /ID# 236701 Louisville Kentucky United States 40213-1014
    16 Mountain Diabetes and Endocrine Center /ID# 235202 Asheville North Carolina United States 28803
    17 Physician's East Endocrinology /ID# 235204 Greenville North Carolina United States 27834
    18 OnSite Clinical Solutions, LLC - Hickory /ID# 238023 Hickory North Carolina United States 28601
    19 Texas Diabetes and Endocrinology - Central Austin /ID# 237137 Austin Texas United States 78731
    20 Texas Diabetes and Endocrinology - South Austin /ID# 238071 Austin Texas United States 78749
    21 North TX Endocrine Center /ID# 237652 Dallas Texas United States 75231
    22 Research Institute Dallas /ID# 237655 Dallas Texas United States 75231
    23 Academy of Diabetes Thyroid and Endocrine /ID# 235870 El Paso Texas United States 79935
    24 Texas Diabetes & Endocrinology /ID# 235860 Round Rock Texas United States 78681
    25 Diabetes & Glandular Disease Clinic P.A. /ID# 235894 San Antonio Texas United States 78229
    26 Rainier Clinical Research Center LLC /ID# 235211 Renton Washington United States 98057
    27 MultiCare Institute for Research & Innovation /ID# 236022 Spokane Washington United States 99202
    28 Multicare Institute for Research and Innovation /ID# 236977 Tacoma Washington United States 98405

    Sponsors and Collaborators

    • Allergan

    Investigators

    • Study Director: ALLERGAN INC., Allergan

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT04124705
    Other Study ID Numbers:
    • 3014-201-002
    First Posted:
    Oct 11, 2019
    Last Update Posted:
    May 13, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 13, 2022