Levothyroxine Replacement With Liquid Gel Capsules vs Tablets Post-thyroidectomy

• Status: Terminated
• Trial end date: 2019-11-04
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: Akrimax Pharmaceuticals

Criteria

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