Patient meeting with a doctor about a hypothyroidism research study

Hypothyroidism Research Study

Investigating Thyroid Extract Tablets for the Treatment of Primary Hypothyroidism
Benefits of Joining a Clinical Trial
  • The potential for improvement of residual hypothyroid symptoms.
  • Contribution to the assessment of a DTE treatment option manufactured with consistent identity, strength, quality, and purity.
Gender
Male and Female
Ages
18-70
Status
Enrolling
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Overview

Hypothyroidism Research Study:

Investigating the efficacy and safety of Desiccated Thyroid Extract (DTE) Tablets for the Treatment of Primary Hypothyroidism

Hypothyroidism occurs when the thyroid gland does not produce enough hormones, which can affect energy levels, metabolism, and overall health. Many people with hypothyroidism take levothyroxine (LT4), a common thyroid hormone replacement medication.

Researchers are studying a new thyroid medication made from desiccated porcine (pig-derived) thyroid extract to see how well it works for people with primary hypothyroidism.

In this study, participants will take one tablet each day. They will receive either the study medication or levothyroxine, a standard treatment already used for hypothyroidism. This study does not use a placebo.

The goal of the study is to learn whether the investigational thyroid medication works as well as the standard levothyroxine treatment in managing hypothyroidism symptoms and thyroid hormone levels.

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About the Study

A Randomized, Double-Blind, Noninferiority Study to Investigate the Efficacy and Safety of Desiccated Porcine Thyroid Extract Tablets for the Treatment of Primary Hypothyroidism.

Hypothyroidism Research Study:

This study is designed to confirm the utility of the investigational product, to treat hypothyroidism. The study is designed to evaluate safety and efficacy of DTE tablets as compared to synthetic T4 (Synthroid).

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Who Can Join

Hypothyroidism Research Study Inclusion Criteria

You may be able to participate if you meet the following conditions:

  • Ages 18 to 70 years.

  • Diagnosis of primary hypothyroidism.

  • Euthyroid status for at least 6 weeks and up to 12 months prior to Screening, with at least one documented minimum stable dose of 50 mcg LT4.

  • TSH value within the normal reference range per central laboratory.

  • Weigh between 110 and 286 pounds
  • Are currently taking a stable dose of levothyroxine or a similar thyroid medication for at least 12 weeks
  • Take a daily thyroid medication dose of at least 50 mcg
  • Have controlled blood pressure and diabetes, if applicable

  • Willing to use oral contraceptives or a barrier method of contraception if of childbearing potential.

You may not be eligible if you:

  • Have a history of thyroid cancer
  • Have taken certain medications that affect thyroid hormone levels or thyroid treatment
  • Have taken weight-loss medications within the past 6 weeks

*Other conditions may apply

Not sure if you qualify?

A member of our study team will review your medical history and medications with you to determine if this study may be a good fit.

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What to Expect

Study Duration:

Duration of participation is approximately 34 weeks, which includes a 4-week screening period, a 4-week run-in period, and a 24-week treatment period.

Study Visits:

Up to 8 visits over 34 weeks

Participants will return to the clinic at Week 6, Week 12, Week 18, and Week 24 for safety visits and end-of-study procedures.

Compensation:

You may be compensated for your time and travel related to study participation. To be discussed.

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See if You Qualify.

To see if you qualify or to learn more, please complete the form

Frequently Asked Questions.

What is a Clinical Trial?

A clinical trial is a research study that evaluates new medications, devices, or treatment approaches to determine if they are safe and effective. Clinical trials help doctors and researchers develop better treatments for current and future patients. All studies follow strict safety guidelines and are carefully monitored.
Each clinical study has requirements for participants based on specific factors such as age, medical history and current health. The eligibility criteria in each study protocol are used to identify the volunteers best qualified to participate.
No. Study-related medications, tests, and medical visits are provided at no cost to you. Participation in a clinical trial should not require you to pay for study-related care.
Many studies provide compensation for time and travel. Compensation varies by study and will be explained before you decide to participate.
Health insurance is not required for most clinical trials. Study-related care is typically provided at no cost to you.
Participation is completely voluntary. You may choose to leave the study at any time, for any reason. Your decision will not affect your regular medical care or benefits.
Each study has specific eligibility criteria based on age, medical history, and other factors. The best way to find out if you qualify is to complete the eligibility form or speak with a research team member.
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