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CompletedNCT01560299Updated Mar 22, 2012

Evaluation of Optimal Time of Methimazole Discontinuation Before Radio-iodine Therapy in Hyperthyroid Grave's Patients

An interventional study of Methimazole and Methimazole in Graves Disease, sponsored by Mashhad University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-03-22.

Sponsored by Mashhad University of Medical Sciences · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Iodine therapy is the best treatment for graves disease.Most patients receive methimozale prior to radio-iodine treatment. This may decrease treatment response to iodine therapy.

Some physicians advice to discontinue methimazole 3 days before radioiodine therapy and others prefer longer off - methimazole period which bothers most patients. This study aimed to evaluate optimum time for methimazole discontinuation in graves disease.

02

Conditions studied

  • Graves Disease

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Keywords

  • hyperthyroidism
  • radio-iodine
  • I-131
  • methimazole
  • graves disease
03

In context

Graves Disease

150 studies on the registry are indexed under Graves Disease; 53 are open to participants now.

This study's enrollment of 150 is above the median of 60 across 92 interventional studies indexed under Graves Disease.

Browse Graves Disease studies →

Lead sponsor

Mashhad University of Medical Sciences is the lead sponsor of 90 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • age 18-65
  • graves disease(TSH\<0.1 \&increased FT4 \& positive TSI
  • one or more bartlena criteria for radio-iodine therapy
  • 24 hour RAIU>25%
  • euthyroidism after methimazole treatment

Exclusion criteria

Exclusion Criteria:

  • pregnancy or lactation
  • moderate or severe graves ophthalmopathy
  • CHF or coronary heart disease
  • palpable thyroid nodule
  • lithium or amiodarone or lugol or ipodate treatment
  • recent imaging with contrast agent
  • very large goiter(more than 150 gram)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Active comparator
    group one

    This group will be advised to discontinue methimazole 24-48 hour before iodine therapy

    Drug: Methimazole

  • Active comparator
    group two

    methimazole stopped 48-72 hour before radioiodine therapy

    Drug: Methimazole

  • Active comparator
    group three

    Drug: Methimazole

Interventions

  • DrugMethimazole

    Methimazole was stopped 24-48 before radio-iodine therapy

  • DrugMethimazole

    methimazole discontinued 49-72 hours before radioiodine treatment

  • DrugMethimazole

    methimazole discontinued 73-168 hours before radio-iodine treatment

06

What researchers measure

Primary outcomes

  1. thyroid function tests over one year after radioiodine therapy

    thyroid function test may change over one year . In order to consider the patients as cured ,thyroid function tests should reveal hypothyroidism or euthyroidism . In order to rule out temporary hypothyroidism the tests should be repeated after 6 months of radioiodine therapy.

    Time frame: months 1 , 3 ,6,9,12

07

Study locations

1 site
  • Mashad University of Medical Sciences
    Mashad, Khorasan Razavi 91766, Iran, Islamic Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01560299
Lead sponsor
Mashhad University of Medical Sciences
Responsible party
S.R.ZAKAVI (associate professor, Mashhad University of Medical Sciences) — Principal investigator
First posted
Mar 22, 2012
Start date
Feb 2010
Primary completion
Jan 2012
Completion
Jan 2012
Last update
Mar 22, 2012

Study contacts

rasoul zakavi, associate professor
principal investigator · Mashhad University of Medical Sciences

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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