Assistance Publique Hopitaux de Marseille
Marseille, 13354, France
NCT Number: NCT01295333
The aim of our study is to compare in a randomized multicentric study the early prophylactic introduction of low dose of LT4 (50 µg/d) at 15 days post-ablation (experimental arm) compared to a conventional approach based on the initiation of LT4 as soon as the first biological signs of hypothyroidism. Two hundred patients with Graves' disease with no or minimal (eyelid retraction or oculopalpebral asynergy) and non inflammatory ophthalmopathy (clinical activity score to 0) will be included in this study. The administrated iodine-131 activity will be adjusted to the weight of the thyroid gland (20 MBq/g thyroid tissue). Patients will be evaluated at 6 weeks, 3 months, 6 months and 12 months post-ablation. The primary objective will assess differences in terms of quality of life at 3 months using a specific questionnaire (ThyPRO). Secondary objectives will compare quality of life outcomes at different study visits (using ThyPRO and SF36), fatigue (MFIS) and depression (Beck), autoimmune parameters (signs of ophthalmopathy, TSH receptor antibodies assessment), efficacy and medico-economic data.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Marseille, 13354, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2 years
Time frame: 2 years
Assistance Publique Hopitaux De Marseille
Other
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