🏛️ Verified NIH Protocol • Sourced via U.S. National Library of Medicine (Last Synced: 2026-01-05)

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

🟢 Recruiting Phase 2 💊 Investigational Drug / Biologic Sponsor: AbbVie

🩺 Protocol Summary

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.

Primary Research Facility: Central Research Associates /ID# 255719 (Birmingham, Alabama)

📋 Basic Study Criteria & Logistics Checklist

0 of 3 Checked

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

Diagnosed with, undergoing evaluation for, or seeking treatment related to Hypothyroidism?

🔍 Study Population / Focus Area (Source: Protocol Primary Condition)

Aged between 18 Years and 75 Years?

🔍 Protocol Specified Age Range: 18 Years to 75 Years

Able to attend required in-person clinic visits and study procedures at one of the participating study centers?

🔍 Logistical Requirement: 139 Registered Participating Sites

📍 Primary Site Map

Site: Central Research Associates /ID# 255719 — Birmingham, Alabama

📍 All Participating Trial Locations (139 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. Central Research Associates /ID# 255719 — Birmingham, Alabama • Contact: (205) 327-1090

2. UAB Hospital /ID# 262565 — Birmingham, Alabama

3. Kaiser San Diego Dept Endocrinology, SCPMG /ID# 262552 — Bonita, California

4. Facey Medical Foundation - Burbank /ID# 262104 — Burbank, California

5. John Muir Medical Center /ID# 257103 — Concord, California • Contact: (925) 687-8860

6. Diagnamics Inc. /ID# 262680 — Encinitas, California

7. Providence - St. Jude Medical Center /ID# 256520 — Fullerton, California

8. NorCal Medical Research /ID# 256512 — Greenbrae, California

9. Velocity Clinical Research - Huntington Park /ID# 259044 — Huntington Park, California

10. Scripps Whittier Diabetes Institute /ID# 259215 — La Jolla, California

11. Facey Medical Foundation /ID# 260863 — Mission Hills, California

12. Hoag Memorial Hospital Presbyterian /ID# 260990 — Newport Beach, California

13. Diabetes Associates Medical Group /ID# 256949 — Orange, California

14. Western University of Health Sciences /ID# 262183 — Pomona, California

15. Research at Mills-Peninsula Medical Center - Sutter Health /ID# 258825 — San Mateo, California

16. Care Access - Santa Clarita /ID# 262573 — Santa Clarita, California

17. Facey Medical Foundation - Valencia /ID# 262102 — Santa Clarita, California

18. Olive View UCLA Medical Center /ID# 259092 — Sylmar, California

19. The Lundquist Institute at Harbor-UCLA Medical Center /ID# 262572 — Torrance, California

20. Diablo Clinical Research /ID# 261329 — Walnut Creek, California

21. San Fernando Valley Health Institute /ID# 257363 — West Hills, California

22. New England Research Associates - Bridgeport /ID# 262184 — Bridgeport, Connecticut

23. Innovative Research of West Florida /ID# 257356 — Clearwater, Florida • Contact: (727) 584-6368

24. ALL Medical Research /ID# 256748 — Cooper City, Florida

25. Northeast Research Institute (NERI) /ID# 261841 — Fleming Island, Florida

📄 Print Doctor Discussion Sheet

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💰 Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act § 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

💡 Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

🏛️ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT06345339 • Last Synced: 2026-01-05

View on ClinicalTrials.gov ↗