Primary Hypothyroidism Clinical Trials

Feel Tired All The Time? It Could Be Hypothyroidism!

Explore the potential of novel therapeutic approaches for Primary Hypothyroidism through clinical trials.

Hypothyroidism is one of the most common thyroid diseases affecting people all over the world regardless of age, sex, and race. With Hypothyroidism, low thyroid hormone levels cause the body’s functions to slow down, leading to general symptoms like cold intolerance, fatigue, loss of energy, and memory problems.

The common endocrine condition is treated by replacing the missing thyroid hormone with synthetic thyroxine pills (LT4), which usually have to be taken every day for life.

Prime Revival Research Institute is conducting Hypothyroidism Clinical Trials to evaluate the safety and efficacy of an investigative natural therapy in people diagnosed with Primary Hypothyroidism.

You may be able to participate if you:

Are between 18 – 75 years of age
Have been diagnosed with Primary Hypothyroidism
Have had no thyroid surgery within the last 12 months
Are on continuous thyroid hormone replacement therapy (LT4) for the last 6 months
Have a body weight between 132.7 – 264.5 pounds

Your doctor will review additional study criteria with you and see if you qualify. If you do qualify and decide to participate in the Hypothyroidism Clinical trials, you will receive all study-related care.

*There is no cost to you or your private medical insurance to participate in the Hypothyroidism Clinical Trials. You will receive monetary compensation for your time and travel.
*If you think you may be eligible to participate in the Hypothyroidism Clinical Trials or would like more information, please enter your information so we can see if you may qualify and can contact you about the study.

About the Hypothyroidism Clinical Trials

Prime Revival Research Institute is conducting a multi-center, Phase 2, double-blind, randomized, clinical study to evaluate the safety and effective dose conversion from LT4 to North Star DTE therapy in patients with Primary Hypothyroidism.

Hypothyroidism Clinical Trials aim to validate the dose conversion between levothyroxine (LT4) and North Star desiccated thyroid extract (DTE) in subjects with primary hypothyroidism who are on a stable dose of LT4. The study will consist of a 4-week screening period, a 30-week treatment period, and an 8-week follow-up. The Hypothyroidism research study is divided into 3 phases:

Screening period (up to 4 weeks).
Treatment period (30 weeks)
Follow-up period (8 weeks)

During the treatment, participants will receive the study drug in capsules packaged into a bottle and will also receive training related to dose administration. Fasting conditions apply to this study drug which might not be the same with other standard replacement therapies.

About Hypothyroidism

The hormones produced by the thyroid gland, thyroxine (tetraiodothyronine, T4) and triiodothyronine (T3), are essential for the proper regulation of metabolism. In Primary Hypothyroidism, the thyroid gland produces an insufficient amount of T3 and T4, which leads to the loss of negative feedback regulation, and increased secretion of TSH in the bloodstream.

Hypothyroidism is manifested by a variety of symptoms, such as fatigue, depressed mood and neurocognition, weight gain, constipation, dry skin, hair loss, cold sensitivity, and an overall decrease in the quality of life (QoL). The long-term health outcomes of hypothyroidism may include cardiovascular conditions, such as ischemic heart disease, heart failure, and stroke.

Numerous risk factors influence the cells in the thyroid, therefore, affecting the production of thyroid hormones. Here are the major causes, from the most to least common:

Autoimmune diseases
Surgical removal of a part or all of the thyroid
Radiation therapy
Congenital hypothyroidism
Thyroiditis
Medicines
Iodine level fluctuation
Damage to the pituitary gland

The standard treatment for Hypothyroidism patients involves synthetic thyroid hormone replacement therapy with levothyroxine (LT4), which provides adequate control of symptoms for most patients.

RecruitingSTATUS AND CRITERIA

$ 99

Per Month

Age 18 – 75 years
Gender Male and Female
Condition Hypothyroidism
Location Texas

Enroll Now

What to Expect?

If you would like to learn more about our Hypothyroidism Clinical Trials, please fill out the form above. One of our research representatives will call you to give you further information about the study. If you qualify for the Hypothyroidism Clinical Trials, you will be invited to our study site for screening. After the screenings, if you qualify and decide to participate, you will be asked to sign an informed consent form which includes the criteria and details of the investigational study treatment.

Once signed, you will be asked health-related questions, and several health assessments and tests will be conducted to help determine if you are eligible as a volunteer. You will be assigned to either of the 2 groups in which you will receive either the study drug (study group) or LT4 tablets (active control group) once daily for 30 weeks.

*Participants will receive free-of-cost investigational treatment. If participants decide to participate in the Primary Hypothyroidism Clinical Research study, they may also receive study-related care from healthcare professionals.

Frequently Asked Questions (FAQs)

1. What are the signs of Hypothyroidism?

Thyroid hormones play a critical role in regulating the body’s metabolism, so their deficiency can lead to a wide range of symptoms. Some common signs experienced by hypothyroidism individuals are fatigue and weakness, weight gain, cold intolerance, dry skin and hair, mood changes, depression, and impaired memory and concentration.

2. At what age is Hypothyroidism common?

Hypothyroidism can occur at any age, but it is more common in women over the age of 60 years. However, it can also affect children, adolescents, and younger adults. In infants and young children, it can lead to developmental delays and growth problems if left untreated.

3. How to diagnose Hypothyroidism?

Hypothyroidism can be diagnosed through a combination of physical examination, blood tests, and evaluation of symptoms. Blood tests are typically used to measure levels of thyroid-stimulating hormone (TSH) and thyroxine (T4) in the blood. If TSH levels are high and T4 levels are low, it may indicate Hypothyroidism.

4. What are the TSH levels in Primary Hypothyroidism?

In Primary Hypothyroidism, TSH levels are significantly higher than the reference range, indicating that the pituitary gland is producing more TSH in an attempt to stimulate the underactive thyroid gland to produce more thyroid hormone. The TSH levels outstand above the upper limit of the reference range (usually around 4.0-5.0 mIU/L) which may indicate Hypothyroidism.

5. What is the best treatment for Primary Hypothyroidism?

The primary treatment for an underactive thyroid (Hypothyroidism) involves the administration of synthetic thyroid hormone replacement therapy. The most commonly prescribed medication is Levothyroxine, which is a synthetic form of the thyroid hormone thyroxine (T4) taken orally, once a day, on an empty stomach, and at least 30 minutes before consuming any other medications or food. The dosage is usually based on the patient’s age, weight, and severity of the hypothyroidism.