Effect of T4-T3 Combination Therapy Versus T4 Monotherapy in Patients With Hypothyroidism
Information source: Copenhagen University Hospital at Herlev
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Quality of Life; Depression
Intervention: Triiodothyronine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Copenhagen University Hospital at Herlev Official(s) and/or principal investigator(s):
Birte Nygaard, Principal Investigator, Affiliation: Herlev Trials
Summary
To compare the effect of T4-T3 combination therapy versus T4 monotherapy in patients with
autoimmune hypothyroidism, on stable T4-substitution therapy
Clinical Details
Official title: Effect of T4-T3 Combination Therapy Versus T4 Monotherapy in Patients With Hypothyroidism,a Double Blind Randomized Cross-Over Study.
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Crossover Assignment, Efficacy Study
Primary outcome: Selv-rating scales:
SF-36, SCL -90-R, BDI
Secondary outcome: BMI, bioimpedance
Detailed description:
double blind randomized cross-over study.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Dept of endocrinology , Herlev Hospital, Herlev dk-3650, Denmark
Additional Information
Starting date: April 2003
Ending date: March 2007
Last updated: September 18, 2007
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