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

NCT ID: NCT04124705

Last Updated: 2024-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 284 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-11
• Study Completion Date: 2021-06-22

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.

Conditions

Hypothyroidism; Thyroid Disease; Euthyroid; Thyroid Gland; Thyroid Hormones

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Armour® Thyroid

Intervention Type: DRUG

Administered orally once a day. the daily dose could range from 1/4 - 2 grains.

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).

Group Type: ACTIVE_COMPARATOR

Levothyroxine

Intervention Type: DRUG

Administered orally once a day; the daily dose could range from 25- 200 µg.

Interventions

Armour® Thyroid

Administered orally once a day. the daily dose could range from 1/4 - 2 grains.

Intervention Type: DRUG

Levothyroxine

Administered orally once a day; the daily dose could range from 25- 200 µg.

Intervention Type: DRUG

Other Intervention Names

Desiccated thyroid extract; AGN-204771; Synthetic T4

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ALLERGAN INC.

Role: STUDY_DIRECTOR

Allergan

Locations

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

Sponsor Site /ID# 235032

Atlanta, Georgia, United States

Sponsor Site /ID# 237199

Columbus, Georgia, United States

Sponsor Site /ID# 238088

Lawrenceville, Georgia, United States

Sponsor Site /ID# 235714

Lexington, Kentucky, United States

Sponsor Site /ID# 236701

Louisville, Kentucky, United States

Sponsor Site /ID# 235202

Asheville, North Carolina, United States

Sponsor Site/ID# 235204

Greenville, North Carolina, United States

Sponsor Site /ID# 238023

Hickory, North Carolina, United States

Sponsor Site /ID# 237137

Austin, Texas, United States

Sponsor Site/ID# 238071

Austin, Texas, United States

Sponsor Site/ID# 237652

Dallas, Texas, United States

Sponsor Site/ID# 237655

Dallas, Texas, United States

Sponsor Site /ID# 235870

El Paso, Texas, United States

Sponsor Site /ID# 235860

Round Rock, Texas, United States

Sponsor Site /ID# 235894

San Antonio, Texas, United States

Sponsor Site /ID# 235211

Renton, Washington, United States

Sponsor Site /ID# 236022

Spokane, Washington, United States

Sponsor Site/ID# 236977

Tacoma, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

3014-201-002

Identifier Type: -

Identifier Source: org_study_id