Improvement in treatment of hypothyroidism using slow-release Liothyronine
- Conditions
- Hypothyroidism.Hypothyroidism, unspecifiedE03.9
- Registration Number
- IRCT20100922004794N12
- Lead Sponsor
- Dorsa Pharmaceutical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion criteria for Phase 2 and Phase 3 are the same as follows: Patients over 20 y. with hypothyroidism caused by any reason e.g. Hashimoto thyroiditis, treated Graves’ patients after radioactive iodine intake, total thyroidectomized patients due to thyroid cancer or congenital hypothyroidism, who take LT4 monotherapy for at least 3 months and attain euthyroid status (TSH=0.5-5 mU/L is optimal).
Exclusion criteria for Phase 2 and Phase 3 are the same as follows: Pregnant women, those with end-organ failure e.g. chronic kidney and liver disease, congestive heart failure, or any kind of cancer, having other cofactors that mimicked symptoms of hypothyroidism, including low Hb, 25[OH] D deficiency, vitamin B12 deficiency, having long-standing psychiatric disorders(e.g major depressive disorders) and fibromyalgia, because those can mask some of the hypothyroid symptoms (eg, fatigue, arthralgia, depression, cognitive slowing); will be excluded. The patients should avoid taking methimazole, PTU, Tamoxifen, and drug-containing estrogen, progesterone, and corticosteroids.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of Life. Timepoint: At baseline and after 12 months. Method of measurement: Thyroid-specific Patient-Reported Outcome short-form (ThyPRO-39) modeled for hypothyroid subjects.
- Secondary Outcome Measures
Name Time Method