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Completed

NCT Number: NCT00531713

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

To compare the effect of T4-T3 combination therapy versus T4 monotherapy in patients with autoimmune hypothyroidism, on stable T4-substitution therapy

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Key information

Conditions

Quality of Life Behavior Behavioral Symptoms Depression Endocrine System Diseases Hypothyroidism Thyroid Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dept of endocrinology , Herlev Hospital

Herlev, dk-3650, Denmark

About this study

double blind randomized cross-over study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triiodothyronine

Drug

50 microgram of the usual T4 is withdrawn and the patients is given 20 microgram of T3

Primary outcomes

  1. Selv-rating scales: SF-36, SCL -90-R, BDI

    Time frame: 3 month treating

Secondary outcomes

  1. BMI, bioimpedance

    Time frame: 3 month treament

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital at Herlev

Other

Registry information

Official study title

Effect of T4-T3 Combination Therapy Versus T4 Monotherapy in Patients With Hypothyroidism,a Double Blind Randomized Cross-Over Study.

Acronym: T4-T3

Important dates

Study start
2003
Study completion
2007
First posted
Sep 19, 2007
Registry last updated
Sep 19, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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