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Hormone Therapy

Levothyroxine Dosing for Hypothyroidism in Older Adults (DOT4 Trial)

Phase 4
Recruiting
Led By Anne R. Cappola, M.D., Sc.M.
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with hypothyroidism of any etiology for at least 6 months, taking 75-200 mcg per day LT4 and a minimum of 1.2 mcg/kg/day with no dose adjustment since the last TSH test
Be older than 65 years old
Must not have
Hypopituitarism
History of thyroid cancer requiring suppression of TSH secretion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will explore if adjusting thyroid hormone levels in elderly people helps them feel better. #ClinicalTrial #LT4 #Thyroid

Who is the study for?
This trial is for community-dwelling individuals aged 65 or older who have been diagnosed with hypothyroidism for at least 6 months, are on a stable dose of Levothyroxine Sodium (75-200 mcg per day), and can take oral medication. They must be able to follow the study procedures throughout its duration. People with hypopituitarism, history of thyroid cancer requiring TSH suppression, severe kidney issues (GFR <30), or those taking certain thyroid medications cannot participate.
What is being tested?
The trial aims to explore the effects of more flexible dosing schedules of Levothyroxine Sodium (LT4) in older adults with hypothyroidism. It will assess how different dosing regimens might impact overall health and management of the condition.
What are the potential side effects?
While not explicitly stated here, common side effects associated with Levothyroxine Sodium may include heart palpitations, increased appetite, weight loss, heat sensitivity, excessive sweating, and nervousness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with hypothyroidism for at least 6 months and am on a stable dose of thyroid medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with hypopituitarism.
Select...
I have had thyroid cancer and need treatment to lower my TSH levels.
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I am currently using medications that affect my thyroid function.
Select...
My kidney function is low, with a GFR under 30.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Thyroid-Related Quality of Life Patient-Reported Outcome Quality of Life scale
Secondary study objectives
Beck Anxiety Inventory
Geriatric Depression Scale
LDL cholesterol
+6 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Higher TSH groupExperimental Treatment1 Intervention
Target TSH level of 5.5-7.0 mU/L
Group II: Lower TSH GroupActive Control1 Intervention
Target TSH level of 0.5-2.0 mU/L
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Levothyroxine Sodium
2019
N/A
~110

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,084 Previous Clinical Trials
42,726,820 Total Patients Enrolled
1 Trials studying Hypothyroidism
14 Patients Enrolled for Hypothyroidism
National Institute on Aging (NIA)NIH
1,802 Previous Clinical Trials
28,193,753 Total Patients Enrolled
2 Trials studying Hypothyroidism
914 Patients Enrolled for Hypothyroidism
Anne R. Cappola, M.D., Sc.M.Principal InvestigatorUniversity of Pennsylvania
1 Previous Clinical Trials
5 Total Patients Enrolled
~152 spots leftby Apr 2028
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