Status:
COMPLETED
A Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants
Lead Sponsor:
Allergan
Conditions:
Hypothyroidism
Thyroid Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 t...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2021
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT04124705
Start Date
October 11 2019
End Date
June 22 2021
Last Update
June 5 2024
Active Locations (28)
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1
Sponsor Site /ID# 237950
Birmingham, Alabama, United States, 35205
2
Sponsor Site /ID# 237986
Little Rock, Arkansas, United States, 72209-7040
3
Sponsor Site /ID# 235210
Greenbrae, California, United States, 94904
4
Sponsor Site /ID# 235716
Huntington Beach, California, United States, 92648