A Study of T3 Therapy in Patients With Hypothyroidism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipe, LLC
ClinicalTrials.gov Identifier:
NCT01800617
First received: February 18, 2013
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Hypothyroidism
Drug: Liothyronine, Sodium
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ipe, LLC:

Primary Outcome Measures:
  • Measurement of Blood Levels of Thyroid Hormone Sensitive Parameters [ Time Frame: Six Weeks. ] [ Designated as safety issue: No ]
    Serum Total T3, TSH


Secondary Outcome Measures:
  • Measurement of Oxygen Consumption [ Time Frame: Six Weeks. ] [ Designated as safety issue: No ]
    Resting Metabolic Rate


Enrollment: 18
Study Start Date: March 2013
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liothyronine, Sodium Drug: Liothyronine, Sodium

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01800617

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

No publications provided

Responsible Party: Ipe, LLC
ClinicalTrials.gov Identifier: NCT01800617     History of Changes
Other Study ID Numbers: BCT303-2
Study First Received: February 18, 2013
Last Updated: July 1, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014