Levothyroxine for Hypothyroidism

Phase-Based Estimates
1
Effectiveness
2
Safety
Virginia Commonwealth University, Richmond, VA
Hypothyroidism+5 More
Levothyroxine - Drug
Eligibility
18+
All Sexes
Eligible conditions
Hypothyroidism

Study Summary

This study is evaluating whether thyroid surgery may have positive impacts for individuals with hypothyroidism.

See full description

Eligible Conditions

  • Hypothyroidism
  • Thyroid Adenoma
  • Thyroid Diseases
  • Goiter
  • Thyroid Neoplasms
  • Thyroid Cancers
  • Thyroid Goiter

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Levothyroxine will improve 3 primary outcomes and 1 other outcome in patients with Hypothyroidism. Measurement will happen over the course of Baseline to 6 months post surgery.

Baseline to 6 months
Energy expenditure (EE)
Month 6
Change in Quality of Life
Change in cholesterol
Short term change in weight

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Single therapy
Combination therapy
Placebo group

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Levothyroxine is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Combination therapyLiothyronine/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.
Single therapyLevothyroxine (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
Levothyroxine
FDA approved
Liothyronine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to 6 months for reporting.

Closest Location

Virginia Commonwealth University - Richmond, VA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Clinical indication for total thyroidectomy
TSH at screening >0.045<4.5mlU/m
Adult men and women Age ≥18-89 years of age
Euthyroid patients with clinical indication for total thyroidectomy
Indication to total thyroidectomy for benign goiter or thyroid cancer not requiring suppressive thyroid hormone therapy

Patient Q&A Section

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

What is hypothyroidism?

Add answer

Hypothyroidism is a condition in which the thyroid does not produce enough thyroid hormones, known as Tl. Symptoms of hypothyroidism include fatigue, weight gain, feeling tired and depression. Hypothyroidism can occur during pregnancy to help give birth to a healthy baby.\n

Unverified Answer

How many people get hypothyroidism a year in the United States?

Add answer

Rates of [hypothyroidism](https://www.withpower.com/clinical-trials/hypothyroidism) are about seven per 100,000 women in the United States each year. Rates are higher among minorities. Thyroiditis in pregnancy can lead to postpartum hypothyroidism in at least 10 percent of treated women.

Unverified Answer

Can hypothyroidism be cured?

Add answer

Thyroid replacement therapy is recommended for the treatment of subacute thyroid failure. It has been shown to be safe and effective; in selected cases it can result in an improvement in the subjective symptoms of the patient.

Unverified Answer

What causes hypothyroidism?

Add answer

The main cause of [hypothyroidism](https://www.withpower.com/clinical-trials/hypothyroidism) is not known, but there are risks to both men and women because of various habits and diseases. For example, thyroid disorders can develop and be triggered by certain drugs like steroids and aspirin. Hypothyroidism is a rare but well-understood condition; so, in the future, better diagnostics and treatment methods might be developed for the treatment of it.

Unverified Answer

What are the signs of hypothyroidism?

Add answer

The symptoms of hypothyroidism include excessive fatigue, weight gain, changes in menstrual cycles, changes in hair coloring, loss of energy and feeling tired. Other signs consist of depressed mood, impaired concentration, lethargy, irregular sleep rhythms and muscle pains.\n

Unverified Answer

What are common treatments for hypothyroidism?

Add answer

In most cases [hypothyroidism](https://www.withpower.com/clinical-trials/hypothyroidism) is treated with thyroid hormone replacement treatment. In the event of nonalcoholic diabetes mellitus, or in patients with cardiovascular risk factors such as hypertension, cholesterol level must be controlled more cautiously by lipid lowering drugs and anti-hypertensive medicines, until the effects of hypothyroidism are reversed. A thyroid functional and hormone examination must be carried out, to exclude sub-clinical hypothyroidism. In cases of severe hypothyroidism, one may consider treatment with thyroid stimulating hormone (TSH) releasing hormone. This treatment does not require an end-point of its own and thus it is often only carried out in people who are incapable of having their TSH level properly measured.

Unverified Answer

What are the latest developments in levothyroxine for therapeutic use?

Add answer

The current study shows that the new drug products are comparable to standard and/or patented levothyroxine. The levothyroxine used has been approved for therapeutic use in the European Union and Australia. The new levothyroxine drug products have been approved for therapeutic use in several countries and are being prescribed for different indications.

Unverified Answer

How does levothyroxine work?

Add answer

Levothyroxine reduces serum TSH concentration by a predictable degree; serum FT4 concentration rises in some patients during dose titration. The increase is not due to increased SHBG production by the liver; it is due to increased production of FT4 by the thyroid. During long-term administration of levothyroxine, circulating levels of FT4 and T3 in both genders remain similar when taken in a conventional (daily) or a low-frequency (periodic) dosage, unless TSH levels are suppressed to a borderline low.

Unverified Answer

Have there been other clinical trials involving levothyroxine?

Add answer

Although many studies of FT4 level and levothyroxine in patients with T3 deficiency exist, none of these trials, including the largest--Toumey's, have addressed the specific clinical concerns raised by Levitt and colleagues--namely, treatment delay, the presence of other symptoms, and the effects of levothyroxine treatment after surgical correction of nodule size have been previously reported. This is the first report that demonstrates a positive result using levothyroxine for the treatment of T3 deficiency or hypothyroidism.

Unverified Answer

How serious can hypothyroidism be?

Add answer

It may be an absolute contraindication to any kind of surgical procedures, although it's important to take into account the severity of the underlying symptoms in the decision-making process. If thyroid function remains impaired, patients should be aware of the possible adverse effects of long-term thyroxine therapy on cardiovascular functioning (e.g. dyslipidemia and worsening of glucose tolerance) although they may not manifest themselves as long as these medications are taken in the requisite doses. However, cardiovascular symptoms may be present in the first 2‐3 years after thyroid replacement and the risks should be duly weighed against the need for further treatment.

Unverified Answer

Does levothyroxine improve quality of life for those with hypothyroidism?

Add answer

levothyroxine is associated with improvements in quality of life at least as good as those reported in previous research for thyroid replacement therapy. Levothyroxine may therefore be suitable for use in the treatment of hypothyroidism.

Unverified Answer

What is the latest research for hypothyroidism?

Add answer

Hypothyroidism has been known to affect the nervous system and cardiovascular system in humans. For example, in rats, hypothyroidism was shown to cause an increase in anxiety, and a loss of attention and short long term memory. These same changes have also been found in humans. As of 2013, a few studies have been performed into the links between hypothyroidism and human mental health. However, studies in animals have generally not been replicated in humans, despite many studies and observational data hinting at such links. In 2013, a systematic review looking at the links between hypothyroidism, depression, and cognitive performance was published. Though this review has limitations (e.g.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Hypothyroidism by sharing your contact details with the study coordinator.