The purpose of this study is to investigate the effect of switching participants taking levothyroxine to a new sodium formulation.
The drug being tested in this study is a new sodium formulation of levothyroxine. Levothyroxine (L-Thyroxine Christiaens®) is used in the treatment of hypothyroidism. This study will investigate the effect of switching subjects taking levothyroxine to a new levothyroxine sodium formulation. The results of this study will be used to provide instructions to general practitioners and endocrinologists assisting patients on levothyroxine hormone substitution in performing the switch to the new formulation. The study will enroll approximately 90 patients. Patients receiving the same daily dose of L-Thyroxine Christiaens® during the past 6 weeks and with serum thyroid stimulating hormone (TSH) levels between 0.4-2.5 mU/L will be switched to the equivalent daily dose of the new formulation of levothyroxine. After the switch, patients will be followed up after 2 (± 2 weeks) and 4 months (± 4 weeks). All participants will be asked to take a daily dose at the same time each day throughout the study. This study will be conducted in Belgium. Participants will make 3 to 4 visits to the clinic.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
101
Levothyroxine tablets
Unnamed facility
Leuven, Belgium
Percentage of Participants That Do Not Need a Change of Dose
Dose change was determined by physician according to their clinical judgement.
Time frame: 2 months (± 2 weeks) after switch to sodium formulation.
Magnitude of the Change in Daily Dose Needed
Magnitude was determined via a change table which provides the percentage of participants that needed a change in Daily Dose (μg/day) of -25 μg, -12.5 μg, -6.25 μg, -5.35 μg, 0 μg or +12.5 μg.
Time frame: 2 months (± 2 weeks) after switch to sodium formulation.
Percentage of Participants That Obtained a Thyroid Stimulating Hormone (TSH) Between 0.4-2.5 mU/L
Blood samples were collected and samples were analyzed according to the local Quality System.
Time frame: Month 4 (± 4 weeks) after inclusion into study.
Absolute Serum Thyroid Stimulating Hormone Values
Blood samples were collected and samples were analyzed according to the local Quality System.
Time frame: Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.
Relative Percent Change From Baseline in Serum Thyroid Stimulating Hormone
Blood samples were collected and samples were analyzed according to the local Quality System. A negative change from Baseline indicated improvement.
Time frame: Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.
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