Trials Sponsors Conditions Drugs Pricing

Conditions

Graves Disease (Basedow's Disease)

Outcome Measures

Primary Outcomes (1)

will assess differences in terms of quality of life at 3 months using a specific questionnaire (ThyPRO).
2 years

Secondary Outcomes (1)

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.
2 years

Study Arms (2)

conventional approach

OTHER

conventional traitment

Drug: The initiation of LT4 as soon as the first biological signs of hypothyroidism.

experimental approach

EXPERIMENTAL

early and systematic traitment

Drug: the early prophylactic introduction of low dose of LT4 (50 µg/d) at 15 days post-ablation

Interventions

the early prophylactic introduction of low dose of LT4 (50 µg/d) at 15 days post-ablationDrug

experimental approach

The initiation of LT4 as soon as the first biological signs of hypothyroidism.Drug

conventional approach

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patient presenting a hyperthyroïdie Basedowienne proving a treatment by iodine 131.
Patient without or with ophtalmopathie junior defined by a score of ophtalmopathie in 0 or in 1 and a score of clinical activity in 0 (see secondary).

Sponsors & Collaborators

Assistance Publique Hopitaux De Marseille
Otherlead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

MeSH Terms

Conditions

Graves Disease

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

ExophthalmosOrbital DiseasesEye DiseasesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormones

Study Officials

BERNARD BELAIGUES
Assistance Publique hôpitaux de Marseille
STUDY DIRECTOR

Enrollment

200 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 27, 2011

First Posted

February 14, 2011

Study Start

May 2011

Date type not reported

This date has not been verified as actual or estimated.

Assessing the Impact of the Early and Systematic Hormonal Replacement After Radio-isotopic Ablation of Graves'hyperthyroïdism on Quality of Life, Efficiency and Tolerance

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

conventional approach

experimental approach

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

conventional approach

experimental approach

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations