Status:
COMPLETED
rhTSH, Thyroid Size, and Radioiodine Therapy in Benign Goiter
Lead Sponsor:
Odense University Hospital
Conditions:
Benign Nontoxic and Toxic Goiter
Graves' Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 introdu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00145366
Start Date
April 1 2002
End Date
July 1 2005
Last Update
December 28 2010
Active Locations (1)
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1
Department of Endocrinology, Odense University Hospital
Odense, Funen, Denmark, 5000