ACTRN12621000237886进行中（未招募）2 期
Thyroid Replacement Options-Pilot Study. To assess the feasibility and design of a large-scale Thyroid Replacement Options study of Australians aged 18-60 years who are dissatisfied with their wellbeing on levothyroxine (LT4) replacement for primary hypothyroidism.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •Provide signed and dated informed consent form
- •- Willing to comply with all study procedures for the duration of the study
- •- Aged 18-60 years
- •- Have confirmed history of hypothyroidism (documented in medical record or confirmed by usual treating medical practitioner), either previous biochemical primary hypothyroidism, total thyroidectomy, or radioiodine ablation
- •- Currently taking LT4 (without any other thyroid hormone products) at a dose greater than or equal to 100 mcg daily of brand names Oroxine or Eutroxsig
- •- Have had recorded serum TSH concentration between 0.3 and 4.0 mU/L within the last three months of the screening visit, or completed after Screening Visit on their current LT4 dose and prior to being enrolled into the trial.
排除标准
- •An individual who meets any of the below criteria will be excluded from participation in the study:
- •- Hypopituitarism
- •- History of thyroid cancer requiring suppression of TSH concentration
- •- Any active malignancy
- •- History of cardiac disease (coronary artery disease, arrhythmia, or heart failure)
- •- History of cirrhosis
- •- History of chronic kidney disease, stage 3 or higher
- •- Current T3-containing treatment
- •- Currently taking LT4 with brand name Eltroxin
- •- Planned or current pregnancy within the trial period
- •- Drug treatment known to affect thyroid hormone metabolism (including amiodarone, cholestyramine, systemic corticosteroids, propranolol, phenytoin, phenobarbital, carbamazepine, lithium, rifampicin, or biotin-containing supplements)
- •- Concurrent participation in another clinical trial
- •- Unable to provide consent
- •- Unable to read sufficiently to perform study tasks (i.e., study questionnaires)
- •- Significant concerns from the study team about the potential participant’s ability to complete, or safety during, the trial
研究者
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