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Recruiting NCT06345339

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

Phase II / Phase III Interventional Hypothyroidism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Armour Thyroid, Levothyroxine.
Who it may be relevant to
Registry conditions: Hypothyroidism. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Puerto Rico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Armour Thyroid
    Oral Capsule or Tablet
  • Drug Levothyroxine
    Oral Capsule

Primary outcome measures

  • Percentage of Participants who Achieve Thyroid-Stimulating Hormone (TSH) Response [Time frame: Week 55]
  • Number of Participants with Adverse Events (AEs) [Time frame: Up to approximately 90 weeks]
Secondary outcome measures (3)
  • Percentage of Participants who Achieve TSH Response [Time frame: Week 55]
  • Number of Participants Needing Altered Dose Conversion from Synthetic T4 to Armour Thyroid [Time frame: Up to approximately 29 weeks]
  • Frequency of Dose Titrations During the Double-Blind (DB) Period Among Participants who Achieved TSH Response at the End of the DB Period [Time frame: Week 55]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 134 centers
  • Central Research Associates /ID# 255719 — Birmingham
  • UAB Hospital /ID# 262565 — Birmingham
  • Kaiser San Diego Dept Endocrinology, SCPMG /ID# 262552 — Bonita
  • Facey Medical Foundation - Burbank /ID# 262104 — Burbank
  • John Muir Medical Center /ID# 257103 — Concord
  • Diagnamics Inc. /ID# 262680 — Encinitas
  • Providence - St. Jude Medical Center /ID# 256520 — Fullerton
  • NorCal Medical Research /ID# 256512 — Greenbrae
  • … and 126 more centers
Puerto Rico · 5 centers

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06345339 · M21-341

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗