An observational study to assess proportion of hypothyroid patients having out-of-range serum TSH values despite being on treatment and to probe reasons for the same

Not Applicable

Completed

Conditions: Health Condition 1: null- Hypothyroidism

Registration Number: CTRI/2011/12/002219

Lead Sponsor: Abbott India Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 2000

Inclusion Criteria

1.Patients of either gender, aged more than or equal to 18 years and less than or equal to 60 years diagnosed with primary hypothyroidism.

2.Currently on treatment with any brand of levothyroxin for at least 3 months and on a stable dose of thyroxin for at least 2 months prior to enrolment.

3.Willing to provide written informed consent.

Exclusion Criteria

1.Patients receiving tri-iodothyronine (T3) as monotherapy or in combination with levothyroxin

2.Patients who are mentally retarded or unable to communicate

3.Patients with central hypothyroidism

4.Patients where hypothyroidism is likely to be transient

5.Pregnant and lactating women

6.Participating in any other clinical study

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To assess percentage (%) of primary hypothyroid patients with abnormal thyroid function (measured using serum TSH level as surrogate marker of thyroid function) despite being prescribed levothyroxin for at least 2 months prior to enrolment in clinical practice among physicians across IndiaTimepoint: NA

Secondary Outcome Measures

Name	Time	Method
1.To assess reasons for out-of range serum TSH values which could be: <br/ ><br>a.Presence of confounding factors (age, etiology of hypothyroidism, concomitant medication and illness etc.) and failure to adjust thyroxin dose for such confounders <br/ ><br>b.Poor compliance on part of patients <br/ ><br>Timepoint: NA;2.To assess their quality of life <br/ ><br>Timepoint: NA