RECRUITINGPhase 2 / Phase 3INTERVENTIONAL
A Study to Assess the Safety and Efficacy of Oral Armour Thyroid Compared to Synthetic T4 for the Treatment of Primary Hypothyroidism in Adult Participants
A Phase 2/3 Multicenter, Double Blinded, Randomized, Dose-conversion, Active Control Study Examining the Efficacy and Safety of Armour Thyroid Compared to Synthetic T4 for the Treatment of Adults With Primary Hypothyroidism
About This Trial
This study will evaluate the efficacy and safety of Armour Thyroid treatment compared with synthetic T4 in subjects who have primary hypothyroidism and are currently stabilized (i.e., in-range thyroid-stimulating hormone \[TSH\]) on synthetic T4 treatment. This study will also therefore evaluate the efficacy and safety of dose conversion from synthetic T4 therapy to Armour Thyroid therapy.
Who May Be Eligible (Plain English)
Who May Qualify:
- Have a diagnosis of primary hypothyroidism made \>= 12 months prior to Screening.
- Be on continuous thyroid replacement therapy of synthetic T4 for primary hypothyroidism for at least 12 months immediately prior to the Screening Visit.
- Be on a stable FDA-approved daily dose of synthetic T4 prior to the Screening visit, and must be taking synthetic T4 dose of at least 25 mcg at Screening visit. Must enter the study using the same stable dose to determine dose conversion.
- Documentation of 1 in-range thyroid-stimulating hormone (TSH) (i.e., within 0.45 - 4.12 mIU/L, inclusive) at Screening and at least 1 additional in range TSH (i.e., within 0.45 - 4.12 mIU/L, inclusive) taken at a minimum of 6 weeks and a maximum of 12 months prior to Screening.
Who Should NOT Join This Trial:
- 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 6 months prior to the Screening.
- Known or suspected allergy or intolerance to any ingredients of Armour Thyroid, including its excipients, synthetic T4, other thyroid replacement medications, or pork products.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Have a diagnosis of primary hypothyroidism made \>= 12 months prior to Screening.
* Be on continuous thyroid replacement therapy of synthetic T4 for primary hypothyroidism for at least 12 months immediately prior to the Screening Visit.
* Be on a stable FDA-approved daily dose of synthetic T4 prior to the Screening visit, and must be taking synthetic T4 dose of at least 25 mcg at Screening visit. Must enter the study using the same stable dose to determine dose conversion.
* Documentation of 1 in-range thyroid-stimulating hormone (TSH) (i.e., within 0.45 - 4.12 mIU/L, inclusive) at Screening and at least 1 additional in range TSH (i.e., within 0.45 - 4.12 mIU/L, inclusive) taken at a minimum of 6 weeks and a maximum of 12 months prior to Screening.
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 6 months prior to the Screening.
* Known or suspected allergy or intolerance to any ingredients of Armour Thyroid, including its excipients, synthetic T4, other thyroid replacement medications, or pork products.
Treatments Being Tested
DRUG
Armour Thyroid
Oral Capsule or Tablet
DRUG
Levothyroxine
Oral Capsule
Locations (20)
Central Research Associates /ID# 255719
Birmingham, Alabama, United States
UAB Hospital /ID# 262565
Birmingham, Alabama, United States
Kaiser San Diego Dept Endocrinology, SCPMG /ID# 262552
Bonita, California, United States
Facey Medical Foundation - Burbank /ID# 262104
Burbank, California, United States
John Muir Medical Center /ID# 257103
Concord, California, United States
Diagnamics Inc. /ID# 262680
Encinitas, California, United States
Providence - St. Jude Medical Center /ID# 256520
Fullerton, California, United States
NorCal Medical Research /ID# 256512
Greenbrae, California, United States
Velocity Clinical Research - Huntington Park /ID# 259044
Huntington Park, California, United States
Scripps Whittier Diabetes Institute /ID# 259215
La Jolla, California, United States
Facey Medical Foundation /ID# 260863
Mission Hills, California, United States
Hoag Memorial Hospital Presbyterian /ID# 260990
Newport Beach, California, United States
Diabetes Associates Medical Group /ID# 256949
Orange, California, United States
Western University of Health Sciences /ID# 262183
Pomona, California, United States
Research at Mills-Peninsula Medical Center - Sutter Health /ID# 258825
San Mateo, California, United States
Care Access - Santa Clarita /ID# 262573
Santa Clarita, California, United States
Facey Medical Foundation - Valencia /ID# 262102
Santa Clarita, California, United States
Olive View UCLA Medical Center /ID# 259092
Sylmar, California, United States
The Lundquist Institute at Harbor-UCLA Medical Center /ID# 262572
Torrance, California, United States
Diablo Clinical Research /ID# 261329
Walnut Creek, California, United States