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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00531713 |
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Date of registration:
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18/09/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of T4-T3 Combination Therapy Versus T4 Monotherapy in Patients With Hypothyroidism
T4-T3 |
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Scientific title:
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Effect of T4-T3 Combination Therapy Versus T4 Monotherapy in Patients With Hypothyroidism,a Double Blind Randomized Cross-Over Study. |
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Date of first enrolment:
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April 2003 |
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Target sample size:
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59 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00531713 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Birte Nygaard |
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Address:
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Telephone:
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Email:
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Affiliation:
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Herlev Trials |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Hypothyroidism, S-TSH> 20 at diagnosis,Anti-TPO >300 Normal TSH (0,4-4,0) for 6
months.
Exclusion Criteria:
- <18 år
- >75 år
- pregnant women
- Thyroid cancer
- T3 treatment
- Post-partum thyroiditis
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Quality of Life
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Depression
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Intervention(s)
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Drug: Triiodothyronine
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Primary Outcome(s)
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Selv-rating scales: SF-36, SCL -90-R, BDI
[Time Frame: 3 month treating]
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Secondary Outcome(s)
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BMI, bioimpedance
[Time Frame: 3 month treament]
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Secondary ID(s)
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T4-T3 hypothyreose
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KA 02022ms
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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