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Hormone Therapy

Group 1 for Hypothyroidism

Phase 2 & 3

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 90 weeks

Awards & highlights

Study Summary

This trial will compare the effectiveness and safety of Armour Thyroid with synthetic T4 in people with hypothyroidism who are currently stable on synthetic T4. It will also assess how well patients respond

Who is the study for?

This trial is for adults with primary hypothyroidism who have been stable on synthetic T4 therapy for at least a year. Participants must have had their thyroid condition diagnosed over 12 months ago and show consistent in-range thyroid-stimulating hormone (TSH) levels.Check my eligibility

What is being tested?

The study compares Armour Thyroid, a natural desiccated thyroid medication, to synthetic T4 (Levothyroxine) in treating hypothyroidism. It will assess the safety and effectiveness of switching from synthetic T4 to Armour Thyroid.See study design

What are the potential side effects?

Potential side effects may include changes in energy levels, heart rate fluctuations, weight changes, sensitivity to heat or cold, hair thinning, and mood swings which are common symptoms associated with adjusting thyroid medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am taking a stable dose of synthetic thyroid hormone (T4) of at least 25 mcg daily.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 90 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 90 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 90 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with Adverse Events (AEs)

Percentage of Participants who Achieve Thyroid-Stimulating Hormone (TSH) Response

Secondary outcome measures

Frequency of Dose Titrations During the Double-Blind (DB) Period Among Participants who Achieved TSH Response at the End of the DB Period

Number of Participants Needing Altered Dose Conversion from Synthetic T4 to Armour Thyroid

Percentage of Participants who Achieve TSH Response

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2Experimental Treatment2 Interventions

Participants will alternate between Armour Thyroid and synthetic T4 for up to 81 weeks.

Group II: Group 1Experimental Treatment1 Intervention

Participants will receive Armour Thyroid for up to 81 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Levothyroxine

2013

Completed Phase 4

~3840

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

966 Previous Clinical Trials

500,708 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

403 Previous Clinical Trials

145,242 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different geographical areas can patients access this clinical trial?

"Patients are being enrolled at L-MARC Research Center /ID# 255733 in Louisville, Kentucky, Lynn Institute of Norman /ID# 256785 in Norman, Oklahoma, and NorCal Medical Research /ID# 256512 in Greenbrae, Florida along with an additional 17 sites."

Answered by AI

Which individuals meet the eligibility criteria to participate in this research study?

"This trial aims to enroll 2800 individuals aged between 18 and 75 who have hypothyroidism. Eligible participants must meet these requirements: A confirmed diagnosis of primary hypothyroidism at least one year before the screening, with documented normal thyroid-stimulating hormone (TSH) levels within the range of 0.45 - 4.12 mIU/L during screening and on another occasion between six weeks and twelve months prior to screening. Additionally, patients should have been consistently receiving FDA-approved synthetic T4 replacement therapy for primary hypothyroidism for a minimum of twelve months leading up to the Screening Visit, maintaining"

Answered by AI

Is there an age requirement in place for participants above 45 years old to be considered for this research project?

"Participants eligible for this study must be aged between 18 and 75 years. Notably, there are separate trials available for individuals under 18 (31 trials) and those over 65 (204 trials)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "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. https://clinicaltrials.gov/ct2/show/NCT06345339.

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