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A Study of T3 Therapy in Patients With Hypothyroidism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01800617
Recruitment Status : Completed
First Posted : February 27, 2013
Last Update Posted : July 2, 2014
Information provided by (Responsible Party):
Ipe, LLC

Brief Summary:
The purpose of this study is to test a new thyroid hormone preparation. The thyroid gland produces two thyroid hormones: mostly T4 and a smaller amount of T3. Thyroid hormone therapy for hypothyroidism or thyroid cancer is generally provided using levothyroxine, which is a synthetic form of T4. T4 is converted into the active hormone T3 in the circulation. Therefore, some researchers believe that T3 levels in T4-treated patients may be slightly lower than in individuals whose own thyroid gland is functioning normally. Symptoms of hypothyroidism have been suggested to occur because of this possible T3 deficiency, although this is controversial. Studies of T3, added to or substituted for T4 in traditional levothyroxine regimens, have generally not shown any benefit of T3. However, it is still possible that no benefit is seen because of the short duration of action or "half-life" of T3. This short-life makes it necessary to dose T3 twice or three times daily. Despite multiple daily doses of T3, T3 levels during its therapy tend to be troubled by peaks and troughs. These peaks can be associated with symptoms of excessive thyroid hormone levels. This study will look at TSH and thyroid hormone levels following a daily dose of a new preparation of T3 that may have longer duration of action than liothyronine. This preparation of T3 is called Thyromax® or BCT303. The investigators believe that steady levels of T3 will be seen after taking Thyromax®. The investigators believe that in patients with hypothyroidism use of Thyromax® in the correct dose will produce normal TSH levels, without producing symptoms of too much thyroid hormone. The goal of future studies is to test whether Thyromax® may be a potential treatment for hypothyroidism, by comparing it with traditional levothyroxine therapy.

Condition or disease Intervention/treatment Phase
Hypothyroidism Drug: Liothyronine, Sodium Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Single Daily-Dose Response Study of a New Liothyronine Sodium (T3) Preparation With Sustained Effects in Hypothyroid Patients
Study Start Date : March 2013
Actual Primary Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothyroidism

Arm Intervention/treatment
Experimental: Liothyronine, Sodium Drug: Liothyronine, Sodium

Primary Outcome Measures :
  1. Measurement of Blood Levels of Thyroid Hormone Sensitive Parameters [ Time Frame: Six Weeks. ]
    Serum Total T3, TSH

Secondary Outcome Measures :
  1. Measurement of Oxygen Consumption [ Time Frame: Six Weeks. ]
    Resting Metabolic Rate

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Hypothyroid patients taking levothyroxine
  • Age 18-65
  • Able to make weekly in-person visits to Washington, D.C.

Exclusion Criteria:

  • Pregnancy or lactation
  • Chronic medical conditions such as heart disease or any other chronic medical conditions such as lung disease (e.g. asthma), kidney disease (e.g. kidney failure), liver disease (e.g. hepatitis), diabetes, or cancer.
  • Steroid medications such as estrogen, progesterone, estrogen or progesterone related medications, testosterone, or glucocorticoids
  • Already taking T3

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01800617

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United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Ipe, LLC

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Responsible Party: Ipe, LLC Identifier: NCT01800617     History of Changes
Other Study ID Numbers: BCT303-2
First Posted: February 27, 2013    Key Record Dates
Last Update Posted: July 2, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
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Thyroid Diseases
Endocrine System Diseases