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
18 Years
65 Years
Open (Enrolling)
Both
Hypothyroidism
Both
Hypothyroidism
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 Hospital | Washington, District of Columbia 20007 |
