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Levothyroxine for Hypothyroidism

Phase 2

Waitlist Available

Led By Francesco S Celi, MD, MHSc

Research Sponsored by Virginia Commonwealth University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 6 months

Summary

This trial compares two treatments for patients who have had their thyroid gland removed. One treatment uses Levothyroxine alone, and the other uses a combination of Levothyroxine and Liothyronine. These treatments replace essential hormones to help the body function normally. Some patients prefer the combination therapy despite mixed results.

Eligible Conditions

Hypothyroidism
Thyroid Goiter
Thyroid Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 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

Change in Cholesterol

Energy Expenditure (EE)

Short Term Change in Weight

Other study objectives

Change in Quality of Life

Side effects data

From 2022 Phase 4 trial • 52 Patients • NCT04288115

Gangrene of toe

catheter ablation of arrhythmogenic focus

revision posterior decompression cervical cord and fusion

transurethral prostatectomy

diarrhea

angina pectoris

fall

fluoroscopy guided percutaneous insertion of drug eluting stent into coronary artery with contrast

hypertensive disorder

low blood pressure

bronchitis

intravitreal injection of anti-vascular endothelial growth factor

carcinoma of prostate

paresthesia of upper limb

restenosis

scalp itchy

shoulder pain

simple extraction of tooth

spasm

polyp of transverse colon

polyp of sigmoid colon

100%

80%

60%

40%

20%

Study treatment Arm

Placebo Group ("Real Discontinuation")

Levothyroxine Group ("Sham Discontinuation")

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Combination therapyExperimental Treatment2 Interventions

Liothyronine/levothyroxine (LT3/LT4) combination therapy. LT4/LT3 group will have 25 mcg of LT4 substituted with 5 mcg LT3 twice daily, to mimic the average daily T3 production form the thyroid The VCU Investigational Pharmacy will over-encapsulate LT4 plus 5 mcg LT3 in "AM" and "PM" color coded capsules. Patients will be instructed to take the AM drug first thing in the morning with water only, and to wait at least 30 minutes before taking other medications coffee or breakfast. The PM dose will be taken at least 30 minutes before dinner. Dose adjustments will be performed at the 6-week and 3-month follow up visits by an unblinded endocrinologist (Dr. Yavuz) aiming to achieve and maintain a target TSH within the normal range and within ± 0.5 mcIU/ml from the baseline (pre-surgery) TSH, Doses will be rounded to the nearest available formulation. No changes will be made in LT3.

Group II: Single therapyActive Control2 Interventions

Levothyroxine (LT4) and placebo (a look-alike inactive substance, a "sugar pill") Patients in the LT4 group will be started at a dose of 1.6 mcg/Kg (52 The VCU Investigational Pharmacy will over-encapsulate LT4 plus placebo, in "AM" and "PM" color coded capsules. Patients will be instructed to take the AM drug first thing in the morning with water only, and to wait at least 30 minutes before taking other medications coffee or breakfast. The PM dose will be taken at least 30 minutes before dinner. Dose adjustments will be performed at the 6-week and 3-month follow up visits by an unblinded endocrinologist (Dr. Yavuz) aiming to achieve and maintain a target TSH within the normal range and within ± 0.5 mcIU/ml from the baseline (pre-surgery) TSH, Doses will be rounded to the nearest available formulation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Liothyronine

2015

Completed Phase 3

~310

Levothyroxine

2013

Completed Phase 4

~3840