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Phase II Single Daily-Dose Response Study of a New Liothyronine Sodium (T3) Preparation With Sustained Effects in Hypothyroid Patients


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Hypothyroidism

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Trial Information

Phase II Single Daily-Dose Response Study of a New Liothyronine Sodium (T3) Preparation With Sustained Effects in Hypothyroid Patients


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Measurement of Blood Levels of Thyroid Hormone Sensitive Parameters

Outcome Description:

Serum Total T3, TSH

Outcome Time Frame:

Six Weeks.

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

BCT303-2

NCT ID:

NCT01800617

Start Date:

March 2013

Completion Date:

Related Keywords:

  • Hypothyroidism
  • Hypothyroidism

Name

Location

Georgetown University HospitalWashington, District of Columbia  20007