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

Hypothyroidism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04124705
• Other study ID #: 3014-201-002
• Status: Completed
• Phase: Phase 2
• Start date: October 11, 2019
• Est. completion date: June 22, 2021

Study information

• Verified date: May 2024
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: June 22, 2021
• Est. primary completion date: June 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Euthyroid
• Hypothyroidism
• Thyroid Disease
• Thyroid Diseases
• Thyroid Gland
• Thyroid Hormones

Intervention

Drug:
• Armour® Thyroid
Administered orally once a day. the daily dose could range from 1/4 - 2 grains.
• Levothyroxine
Administered orally once a day; the daily dose could range from 25- 200 µg.

Locations

Country	Name	City	State
United States	Sponsor Site /ID# 235202	Asheville	North Carolina
United States	Sponsor Site /ID# 235032	Atlanta	Georgia
United States	Sponsor Site /ID# 237137	Austin	Texas
United States	Sponsor Site/ID# 238071	Austin	Texas
United States	Sponsor Site /ID# 237950	Birmingham	Alabama
United States	Sponsor Site /ID# 237199	Columbus	Georgia
United States	Sponsor Site/ID# 237652	Dallas	Texas
United States	Sponsor Site/ID# 237655	Dallas	Texas
United States	Sponsor Site/ID# 235866	Denver	Colorado
United States	Sponsor Site /ID# 235870	El Paso	Texas
United States	Sponsor Site /ID# 235853	Fort Lauderdale	Florida
United States	Sponsor Site /ID# 235210	Greenbrae	California
United States	Sponsor Site/ID# 235204	Greenville	North Carolina
United States	Sponsor Site /ID# 238023	Hickory	North Carolina
United States	Sponsor Site /ID# 235716	Huntington Beach	California
United States	Sponsor Site /ID# 238088	Lawrenceville	Georgia
United States	Sponsor Site /ID# 235714	Lexington	Kentucky
United States	Sponsor Site /ID# 237986	Little Rock	Arkansas
United States	Sponsor Site /ID# 236701	Louisville	Kentucky
United States	Sponsor Site /ID# 235211	Renton	Washington
United States	Sponsor Site /ID# 235860	Round Rock	Texas
United States	Sponsor Site /ID# 238120	Sacramento	California
United States	Sponsor Site /ID# 235894	San Antonio	Texas
United States	Sponsor Site /ID# 238026	Santa Clarita	California
United States	Sponsor Site /ID# 236022	Spokane	Washington
United States	Sponsor Site/ID# 236977	Tacoma	Washington
United States	Sponsor Site /ID# 238258	Van Nuys	California
United States	Sponsor Site /ID# 236809	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)