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Sponsored by: |
Odense University Hospital |
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Information provided by: | Odense University Hospital |
ClinicalTrials.gov Identifier: | NCT00145366 |
The trials in this protocol deals with the effect of pretreatment with rhTSH on radioiodine treatment of thyroid size and function, in patients with nontoxic and toxic nodular goiter. It is an introduction of a novel principle, based on prospective, randomized double blind investigations. Attached to this, we investigate the acute effects of rhTSH on thyroid size (measured by ultrasonography), both in healthy individuals and in patients with nontoxic nodular goiter. Thus, the investigations are divided into 4 categories listed below:
Does administration of 0.3 mg recombinant human TSH affect thyroid function and volume in healthy individuals and in patients with multinodular non-toxic goiter? A randomized double-blind cross-over trial.
As a final note we investigate, in a pilot-study;
Condition | Intervention | Phase |
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Benign Nontoxic and Toxic Goiter Graves’ Disease |
Drug: Recombinant human thyrotropin (Thyrogen) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Pretreatment With Recombinant Human Thyrotropin (rhTSH) for the Effect on Thyroid Size and Function, and for the Effect of Radioiodine Treatment in Patients With Nodular Goiter. Prospective, Randomized Double-Blinded Trials. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Denmark, Funen | |
Department of Endocrinology, Odense University Hospital | |
Odense, Funen, Denmark, 5000 |
Principal Investigator: | Viveque Egsgaard Nielsen, MD | Odense University Hospital |
Study ID Numbers: | 008 |
Study First Received: | September 2, 2005 |
Last Updated: | November 27, 2006 |
ClinicalTrials.gov Identifier: | NCT00145366 |
Health Authority: | Denmark: National Board of Health |
Benign nontoxic and toxic goiter rhTSH 131I goiter reduction 131I kinetic |
thyroid size patient satisfaction adverse effects BRT Graves’ disease |
Goiter Autoimmune Diseases Eye Diseases Graves Disease Endocrine System Diseases Endocrinopathy |
Orbital Diseases Goiter, Nodular Graves' disease Hyperthyroidism Thyroid Diseases |
Immune System Diseases Exophthalmos |