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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
Awards & highlights

Study Summary

This trial is testing two different treatments for hypothyroidism to see how they affect energy levels, heart function, and cholesterol.

Eligible Conditions
  • Hypothyroidism
  • Thyroid Goiter
  • Thyroid Cancer

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in cholesterol
Energy expenditure (EE)
Short term change in weight
Other outcome measures
Change in Quality of Life

Side effects data

From 2022 Phase 4 trial • 52 Patients • NCT04288115
5%
carcinoma of prostate
5%
polyp of sigmoid colon
5%
polyp of transverse colon
5%
restenosis
5%
fall
5%
fluoroscopy guided percutaneous insertion of drug eluting stent into coronary artery with contrast
5%
paresthesia of upper limb
5%
simple extraction of tooth
5%
revision posterior decompression cervical cord and fusion
5%
Gangrene of toe
5%
catheter ablation of arrhythmogenic focus
5%
hypertensive disorder
5%
angina pectoris
5%
intravitreal injection of anti-vascular endothelial growth factor
5%
low blood pressure
5%
shoulder pain
5%
diarrhea
5%
transurethral prostatectomy
5%
spasm
5%
bronchitis
5%
scalp itchy
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,356 Previous Clinical Trials
4,315,053 Total Patients Enrolled
4 Trials studying Hypothyroidism
2,856 Patients Enrolled for Hypothyroidism
Virginia Commonwealth UniversityLead Sponsor
697 Previous Clinical Trials
22,884,983 Total Patients Enrolled
Francesco S Celi, MD, MHScPrincipal InvestigatorVirginia Commonwealth University
1 Previous Clinical Trials
3 Total Patients Enrolled

Media Library

Levothyroxine Clinical Trial Eligibility Overview. Trial Name: NCT04782856 — Phase 2
Hypothyroidism Research Study Groups: Combination therapy, Single therapy
Hypothyroidism Clinical Trial 2023: Levothyroxine Highlights & Side Effects. Trial Name: NCT04782856 — Phase 2
Levothyroxine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04782856 — Phase 2

Frequently Asked Questions

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

To what afflictions is Levothyroxine commonly prescribed?

"Levothyroxine is generally used to treat plasmapheresis, yet it can also be effective as a supplementary or complementary treatment for additional medical issues such as blood specimen collection and caloric deficit."

Answered by AI

What is the current intake capacity for this clinical experiment?

"That is accurate. As per the records hosted on clinicaltrials.gov, this research project, originally posted in October 28th 2020, continues to solicit new participants and currently needs 30 volunteers from 1 medical centre."

Answered by AI

Is this the inaugural attempt to conduct this trial?

"Presently, there are 19 Levothyroxine trials running in 171 cities and 29 countries. This pharmaceutical drug's first trial was completed by Baxter Healthcare Corporation in 2007 as part of its Phase 4 drug approval process with a collective sample size of 4640 patients. To date, 18447 studies have been concluded since then."

Answered by AI

Are there opportunities for new participants to join this clinical trial?

"Per the information housed on clinicaltrials.gov, this investigation is still recruiting participants; it was first advertised on October 28th 2020 and was last modified on April 25th 2022."

Answered by AI

Does the FDA sanction Levothyroxine for medicinal purposes?

"With data only to support Levothyroxine's safety, it was given a rating of 2 out of 3 by Power. This is due to the Phase 2 status of this trial, meaning efficacy has yet to be established."

Answered by AI

To what demographic is enrollment in this research endeavor available?

"This study seeks 30 individuals afflicted with hypothyroidism, between the ages of 18 and 89. Most critically, participants must meet these primary requirements: Adult males or females aged at least 18 but no more than 89 years old."

Answered by AI

What additional research has been conducted surrounding Levothyroxine?

"Currently, there are 19 active clinical trials involving Levothyroxine. Out of these investigations, 5 have progressed to Phase 3 thus far. While the majority occur in Jinan, Shandong Province, this research is being conducted across 245 distinct medical centres worldwide."

Answered by AI

Is the age threshold for participation in this experiment higher than 30 years?

"The enrollment criteria mandates that participants should be between 18 and 89 years old. 36 studies are available for minors while 241 clinical trials apply to seniors."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
Maryland
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Energy Metabolism in Thyroidectomized Patients
2020. "Energy Metabolism in Thyroidectomized Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04782856.
~3 spots leftby Apr 2025
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