Subclinical hypothyroidism
Conditions
Interventions
Trade Name: Euthyrox 25 µg
Product Name: Euthyrox
Pharmaceutical Form: Tablet
INN or Proposed INN: LEVOTHYROXINE
CAS Number: 51489
Current Sponsor code: Euthyrox
Other descriptive name: L-Thyroxine
Co
Sponsors
Institut für klinische Forschung und Entwicklung Berlin GmbH am St. Hedwig Krankenhaus
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: 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 • change/improvement of memory function;Secondary Objective: Secondary objectives: • change/improvement of psychometric parameters • change/improvement of Depression and anxiety • change/improvement of the quality of life (EQ-5D) • patients subjective evaluation of the tolerance, therapy satisfaction and the willingness for a subsequent treatment • adverse events ;Primary end point(s): Improvement of memory tests;Timepoint(s) of evaluation of this end point: after 52 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Improvement of psychometric parameters Improvement of Depression and anxiety Improvement of the quality of life (EQ-5D) Patients subjective evaluation of the tolerance, therapy satisfaction and the willingness for a subsequent treatment Adverse events ;Timepoint(s) of evaluation of this end point: after 52 weeks of treatment | — |
Countries
Germany
Contacts
Public ContactIKFE Berlin GmbH
Institut für Klinische Forschung und Entwicklung Berlin GmbH
Outcome results
None listed