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rhTSH, Thyroid Size, and Radioiodine Therapy in Benign Goiter

This study has been completed.
Information provided by:
Odense University Hospital Identifier:
First received: September 2, 2005
Last updated: December 27, 2010
Last verified: April 2009

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:

  1. Prospective randomized double blind study of pretreatment with 0.3 mg recombinant human TSH for the effect of radioiodine in nontoxic multinodular goiter.
  2. Prospective randomized double blind study of the pretreatment with 0.3 mg recombinant human TSH for the effect of radioiodine on thyroid size and function in patients with a very large (>100 ml) nontoxic or toxic goiter.
  3. Does administration of 0.9 mg recombinant human TSH affect thyroid function and volume in healthy individuals? A randomized double-blind cross-over trial.
  4. 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;

  5. The influence of rhTSH on thyroid radioiodine uptake in patients with hyperthyroidism treated with continuous block-replacement therapy.

Condition Intervention Phase
Benign Nontoxic and Toxic Goiter
Graves' Disease
Drug: Recombinant human thyrotropin (Thyrogen)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Ultrasonography/MR of the thyroid gland/benign goiter, in order to determine thyroid size after intervention.

Estimated Enrollment: 110
Study Start Date: April 2002
Study Completion Date: July 2005

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy volunteers with an intact thyroid gland
  • Patients with nontoxic/subtoxic nodular goiter confirmed by ultrasonography
  • Patients with toxic nodular goiter
  • Patients with Graves' disease

Exclusion Criteria:

  • Treatment with drugs that alter thyroid function or size (the last 3 months prior to inclusion)
  • Prior 131I treatment
  • Alcohol, medicine or drug abuse
  • Pregnancy or lactation
  • No safe contraception
  • Participation in another clinical trial
  • Allergic reaction towards rhTSH
  • Fine needle biopsy without valid diagnostic criteria for benign disease
  • Suspicion of malignancy, increased ionized serum calcium and/or serum calcitonin
  • Incontinence
  • Physically or psychic condition that hinders corporation
  • Ischemic attack up till 3 months before inclusion
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Please refer to this study by its identifier: NCT00145366

Department of Endocrinology, Odense University Hospital
Odense, Funen, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Principal Investigator: Viveque Egsgaard Nielsen, MD Odense University Hospital
  More Information

Publications: Identifier: NCT00145366     History of Changes
Other Study ID Numbers: 008
Study First Received: September 2, 2005
Last Updated: December 27, 2010

Keywords provided by Odense University Hospital:
Benign nontoxic and toxic goiter
goiter reduction
131I kinetic
thyroid size
patient satisfaction
adverse effects
Graves' disease

Additional relevant MeSH terms:
Graves Disease
Orbital Diseases
Eye Diseases
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on May 23, 2017