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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypothyroidism; Thyroid Disease; Euthyroid; Thyroid Gland; Thyroid Hormones
• Intervention / Treatment: Drug: Armour® Thyroid; Drug: Levothyroxine

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 Type: Interventional
• Enrollment (Actual): 284
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Sponsor Site /ID# 237950
  • Arkansas
    • Little Rock, Arkansas, United States, 72209-7040
      • Sponsor Site /ID# 237986
  • California
    • Greenbrae, California, United States, 94904
      • Sponsor Site /ID# 235210
    • Huntington Beach, California, United States, 92648
      • Sponsor Site /ID# 235716
    • Sacramento, California, United States, 95821-2123
      • Sponsor Site /ID# 238120
    • Santa Clarita, California, United States, 91321
      • Sponsor Site /ID# 238026
    • Van Nuys, California, United States, 91405-3605
      • Sponsor Site /ID# 238258
  • Colorado
    • Denver, Colorado, United States, 80246
      • Sponsor Site/ID# 235866
  • Florida
    • Fort Lauderdale, Florida, United States, 33312
      • Sponsor Site /ID# 235853
    • West Palm Beach, Florida, United States, 33401
      • Sponsor Site /ID# 236809
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Sponsor Site /ID# 235032
    • Columbus, Georgia, United States, 31904
      • Sponsor Site /ID# 237199
    • Lawrenceville, Georgia, United States, 30046
      • Sponsor Site /ID# 238088
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Sponsor Site /ID# 235714
    • Louisville, Kentucky, United States, 40213-1014
      • Sponsor Site /ID# 236701
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Sponsor Site /ID# 235202
    • Greenville, North Carolina, United States, 27834
      • Sponsor Site/ID# 235204
    • Hickory, North Carolina, United States, 28601
      • Sponsor Site /ID# 238023
  • Texas
    • Austin, Texas, United States, 78731
      • Sponsor Site /ID# 237137
    • Austin, Texas, United States, 78749
      • Sponsor Site/ID# 238071
    • Dallas, Texas, United States, 75231
      • Sponsor Site/ID# 237652
    • Dallas, Texas, United States, 75231
      • Sponsor Site/ID# 237655
    • El Paso, Texas, United States, 79935
      • Sponsor Site /ID# 235870
    • Round Rock, Texas, United States, 78681
      • Sponsor Site /ID# 235860
    • San Antonio, Texas, United States, 78229
      • Sponsor Site /ID# 235894
  • Washington
    • Renton, Washington, United States, 98057
      • Sponsor Site /ID# 235211
    • Spokane, Washington, United States, 99202
      • Sponsor Site /ID# 236022
    • Tacoma, Washington, United States, 98405
      • Sponsor Site/ID# 236977

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	End of the titration period (Week 18, 24, 30, or 36)

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: ALLERGAN INC., Allergan

Publications and helpful links

Helpful Links

• Additional information on study locations near you may be found at AllerganClinicalTrials.com.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2019
• Primary Completion (Actual): June 22, 2021
• Study Completion (Actual): June 22, 2021

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 10, 2019
• First Posted (Actual): October 11, 2019

Study Record Updates

• Last Update Posted (Actual): June 5, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Hypothyroidism; Thyroid Diseases
• Other Study ID Numbers: 3014-201-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• 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