Survey for the Initial Treatment of Hypothyroidism in France
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,285
- 试验地点
- 1
- 主要终点
- Initial questionnaire
研究概览
简要总结
This observational survey with prospective and/or retrospective follow-up is designed to study practices for the initial treatment of hypothyroidism in France without modifying subject treatment.
详细描述
Thyroid disorder can be central, caused by a deficiency in thyroid stimulating hormone (TSH) production; or peripheral, caused by the decrease in the plasma concentration of thyroid hormones, more specifically of free thyroxine (free T4). Peripheral hypothyroidism is caused by the decrease in the production capacities of the thyroid gland.
The treatment of hypothyroidism is based on the restoration and maintenance of biological (judged on the basis of the standardised TSH and T4 values) and clinical euthyroidism.
A number of forms of thyroid hormones are available in the French market (Euthyral®, Cynomel®, L-thyroxine drops®), of which, Levothyrox® is the most frequently prescribed drug in this category.
The treatment of peripheral hypothyroidism, in particular, is well codified and almost consensual. In France, there is no published observational study, based on which one can document the manner in which subjects are treated. This observational study is set up to document these practices.
OBJECTIVES The principal objectives of this survey is to to get information on the use of Levothyrox in France
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recently diagnosed hypothyroid subject (either during the inclusion period, or within the 6 previous months) for whom, data related to the diagnosis is available if the diagnosis was not carried out initially by the investigating doctor
- •Subject, who has given his/her oral consent for participation
排除标准
- •Subject included in clinical trial or having participated in a clinical trial during the last 3 months
- •Subject presenting a major and objectifiable risk of not being able to follow-up until the next TSH level (moving, problems encountered during another study, pathology affecting the vital prognosis in the short-term)
- •All contraindications to Lévothyrox
结局指标
主要结局
Initial questionnaire
时间窗: Baseline
Documentation of indications for levothyroxine treatment
次要结局
- Follow-up questionnaire(3 months)