Phase 2
Completed N=101
Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test Formulation
Source: ClinicalTrials.gov NCT01916304 ↗Enrolled (actual)
101
Serious AEs
6.9%
Results posted
Jul 2015
Primary outcomePrimary: Percentage of Participants That Do Not Need a Change of Dose — 32.9 percentage of participants
Summary
The purpose of this study is to investigate the effect of switching participants taking levothyroxine to a new sodium formulation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants That Do Not Need a Change of Dose |
32.9 | — |
| SECONDARY Magnitude of the Change in Daily Dose Needed |
19.51; 42.68; 1.22; 1.22; 32.93; 2.44 | — |
| SECONDARY Percentage of Participants That Obtained a Thyroid Stimulating Hormone (TSH) Between 0.4-2.5 mU/L |
57.3 | — |
| SECONDARY Absolute Serum Thyroid Stimulating Hormone Values |
1.1; 0.3; 0.6 | — |
| SECONDARY Relative Percent Change From Baseline in Serum Thyroid Stimulating Hormone |
-74.5; -54.0 | — |
Eligibility Criteria
Inclusion Criteria
- (Near) total thyroidectomised patients.
- Aged 18 years and older.
- Stabilised on the same daily dose of L-Thyroxine Christiaens® during the last 6 weeks before inclusion in the study.
- Written informed consent given.
- Able and willing to comply with protocol requirements and to complete the study.
Exclusion Criteria
- History of Graves' disease or positive TSH-receptor antibodies.
- History of thyroid cancer requiring TSH suppression.
- Medical procedures or treatments planned that could influence the thyroid hormone state of the patients during this trial.
- Use of levothyroxine containing medicines provided by other brands to treat hypothyroidism.
- Pregnant or planning pregnancy. Female patients of childbearing potential need to apply highly effective methods of birth control.
- Participation in another trial in the past 6 weeks.
- Exclusion criteria during the study are the occurrence of any serious adverse reaction, any laboratory or clinically relevant change in patient status, any change in smoking status, use of drugs non-authorized by the physician (to avoid relevant drug interactions) and lack of patient compliance with the study drug. (OR events not considered as exclusion criteria but to be documented in the case report form, as a possible explanation for change in lab parameters and/or dose switch).
Data sourced from ClinicalTrials.gov (NCT01916304). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.