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Compares treatment options for Hypothyroidism
Official title 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
ClinicalTrials.gov ID: NCT06345339
What this study is testing
What is Armour Thyroid?
Armour Thyroid is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hypothyroidism.
Also referred to as AGN-282176.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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...
- 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...
You likely can't join if
- Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion of Armour Thyroid or...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Bonita, California, United States
- Burbank, California, United States
- Concord, California, United States
- Encinitas, California, United States
- Fullerton, California, United States
- Greenbrae, California, United States
- Huntington Park, California, United States
- La Jolla, California, United States
- Mission Hills, California, United States
- Newport Beach, California, United States
- Orange, California, United States
- Pomona, California, United States
- San Mateo, California, United States
- Santa Clarita, California, United States
- Sylmar, California, United States
- Torrance, California, United States
- Walnut Creek, California, United States
- West Hills, California, United States
- Bridgeport, Connecticut, United States
+ 95 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Bonita, California, United States; Burbank, California, United States; Concord, California, United States; Encinitas, California, United States; Fullerton, California, United States and 109 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.