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Effect of T4-T3 Combination Therapy Versus T4 Monotherapy in Patients With Hypothyroidism

Information source: Copenhagen University Hospital at Herlev
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

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
Last updated: September 18, 2007

Page last updated: August 23, 2015

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