Clinical trial · Interventional
Levothyroxine Replacement With Liquid Gel Capsules vs Tablets Post-thyroidectomy
Levothyroxine Replacement With Liquid Gel Capsules or Tablets in Post-thyroidectomy Stage in Low Risk Differentiated Thyroid Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminating study as sponsor has sold the drug to another company
Summary
Brief summary (as posted)
In some patients, levothyroxine liquid gel capsules may demonstrate superior absorption than the tablet option. Impaired absorption of thyroid hormone directly correlates to higher and more unpredictable TSH (thyroid stimulating hormone) levels. The investigators therefore hypothesize that following thyroidectomy for Stage I/II differentiated thyroid cancer the gel capsule levothyroxine formulation will provide more predictable TSH results and in turn require fewer dose adjustments to achieve optimal hormone levels in the postoperative period. The aim of this investigation is to compare the use of levothyroxine in liquid gel capsules to tablet form for TSH suppression following thyroidectomy for presumed stage I/II differentiated thyroid cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Postsurgical Hypothyroidism | — | UNRESOLVED | — |
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Levothyroxine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tablets
- description
- Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)
- interventionNames
- Drug: Levothyroxine
- type
- EXPERIMENTAL
- label
- Gelcaps
- description
- Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)
- interventionNames
- Drug: Levothyroxine
Primary outcomes (1)
- measure
- Number of Patients in Each Group at Predefined Target TSH Range at 18 Weeks
- timeFrame
- 18 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years * Presumed AJCC (American Joint Committee on Cancer) tumor Stage I or II * Planned total or near-total thyroidectomy * Planned goal TSH suppression 0.1-0.5 mU/L for at least 18 weeks postoperatively * Normal serum TSH within 12 months preceding surgery Exclusion Criteria: * AJCC Stage III or greater * Undifferentiated, Anaplastic or Medullary Thyroid Cancer * Planned postoperative TSH goal other than 0.1-0.5 mU/L * History of gastrointestinal malabsorption or gastric bypass surgery * Pregnancy * Use of medications that alter the absorption or metabolism of levothyroxine * Prior use of levothyroxine
References
Publications (2)
- BACKGROUNDVita R, Fallahi P, Antonelli A, Benvenga S. The administration of L-thyroxine as soft gel capsule or liquid solution. Expert Opin Drug Deliv. 2014 Jul;11(7):1103-11. doi: 10.1517/17425247.2014.918101. Epub 2014 Jun 4. PMID 24896369
- BACKGROUNDMcMillan CV, Bradley C, Woodcock A, Razvi S, Weaver JU. Design of new questionnaires to measure quality of life and treatment satisfaction in hypothyroidism. Thyroid. 2004 Nov;14(11):916-25. doi: 10.1089/thy.2004.14.916. PMID 15671770