A study to evaluate the efficacy of treatment with thyroid hormon in comparison to placebo in patients with borderline thyroid hypofunctio
- Conditions
- Subclinical hypothyroidismTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2010-023509-37-DE
- Lead Sponsor
- Institut für klinische Forschung und Entwicklung Berlin GmbH am St. Hedwig Krankenhaus
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1.Male or female, 18 - 64 years old at screening
2.Serum TSH 3 - 10 mU/L and fT3 and fT4 in normal range at screening
3.Willing and able to provide written informed consent and to participate in all study specific procedures
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Known clinically significant thyroid diseases requiring treatment
2.Use of any thyroid medication 8 weeks before screening
3.Pregnant or breastfeeding patients or patients planning to become pregnant in the next year
4.Symptomatic coronary artery disease, heart failure, tachycardic arrhythmia
5.Severe depression or other psychiatric disorders requiring treatment
6.Medication with a significant impact on thyroid function (see Appedix 2)
7.Clinically significant abnormal laboratory values at screening
8.Patients with galactose intolerance, lactase deficiency or glucose-galactose malabsorption
9.Participation in another study in the last 30 days before screening
10.Alcohol and/or drug abuse or dependence
11. Severe illnesses (such as cancer, clinically significant cardiovascular, gastrointestinal, pulmonary, endocrinological, neurological, psychiatric disorders), which would compromise the patient´s safety during the study
12.MMSE test score < 18
13.Insufficient knowledge of German to understand the questionnaires
14.Other factors (such as psychosocial stress, administrative factors, inadequate understanding of the study), which would compromise a successful participation in the clinical study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary objective: <br>The primary objective of this study is to show an amelioration of cognitive and psychometric parameters in patients with subclinical hypothyroidism under the therapy with levothyroxine <br>•change/improvement of memory function;Secondary Objective: Secondary objectives: <br>• change/improvement of psychometric parameters<br>• change/improvement of Depression and anxiety<br>• change/improvement of the quality of life (EQ-5D)<br>•patients subjective evaluation of the tolerance, therapy satisfaction and the willingness for a subsequent treatment <br>•adverse events<br>;Primary end point(s): Improvement of memory tests;Timepoint(s) of evaluation of this end point: after 52 weeks of treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Improvement of psychometric parameters<br>Improvement of Depression and anxiety<br>Improvement of the quality of life (EQ-5D)<br>Patients subjective evaluation of the tolerance, therapy satisfaction and the willingness for a subsequent treatment <br>Adverse events<br>;Timepoint(s) of evaluation of this end point: after 52 weeks of treatment