Clinical trial NCT04124705: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypothyroidism
Thyroid Disease
Euthyroid
Thyroid Gland
Thyroid Hormones
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2019-10-11
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of Participants With a Sustained TSH Response
timeFrame: 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 outcomes:
measure: Percentage of Participants With a Titration TSH Response
timeFrame: End of the titration period (Week 18, 24, 30, or 36)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sponsor Site /ID# 237950
state: Alabama
city: Little Rock
country: United States
facility: Sponsor Site /ID# 237986
state: Arkansas
city: Greenbrae
country: United States
facility: Sponsor Site /ID# 235210
state: California
city: Huntington Beach
country: United States
facility: Sponsor Site /ID# 235716
state: California
city: Sacramento
country: United States
facility: Sponsor Site /ID# 238120
state: California
city: Santa Clarita
country: United States
facility: Sponsor Site /ID# 238026
state: California
city: Van Nuys
country: United States
facility: Sponsor Site /ID# 238258
state: California
city: Denver
country: United States
facility: Sponsor Site/ID# 235866
state: Colorado
city: Fort Lauderdale
country: United States
facility: Sponsor Site /ID# 235853
state: Florida
city: West Palm Beach
country: United States
facility: Sponsor Site /ID# 236809
state: Florida
city: Atlanta
country: United States
facility: Sponsor Site /ID# 235032
state: Georgia
city: Columbus
country: United States
facility: Sponsor Site /ID# 237199
state: Georgia
city: Lawrenceville
country: United States
facility: Sponsor Site /ID# 238088
state: Georgia
city: Lexington
country: United States
facility: Sponsor Site /ID# 235714
state: Kentucky
city: Louisville
country: United States
facility: Sponsor Site /ID# 236701
state: Kentucky
city: Asheville
country: United States
facility: Sponsor Site /ID# 235202
state: North Carolina
city: Greenville
country: United States
facility: Sponsor Site/ID# 235204
state: North Carolina
city: Hickory
country: United States
facility: Sponsor Site /ID# 238023
state: North Carolina
city: Austin
country: United States
facility: Sponsor Site /ID# 237137
state: Texas
city: Austin
country: United States
facility: Sponsor Site/ID# 238071
state: Texas
city: Dallas
country: United States
facility: Sponsor Site/ID# 237652
state: Texas
city: Dallas
country: United States
facility: Sponsor Site/ID# 237655
state: Texas
city: El Paso
country: United States
facility: Sponsor Site /ID# 235870
state: Texas
city: Round Rock
country: United States
facility: Sponsor Site /ID# 235860
state: Texas
city: San Antonio
country: United States
facility: Sponsor Site /ID# 235894
state: Texas
city: Renton
country: United States
facility: Sponsor Site /ID# 235211
state: Washington
city: Spokane
country: United States
facility: Sponsor Site /ID# 236022
state: Washington
city: Tacoma
country: United States
facility: Sponsor Site/ID# 236977
state: Washington
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References: