NCT00111735

Brief Summary

The aim of the study is to examine the effects of fine titration of thyroxine dosage on symptoms of hypothyroidism, wellbeing and quality of life. The hypothesis is that symptoms of hypothyroidism, wellbeing and quality of life will be improved in thyroxine-treated subjects when serum thyrotropin (TSH) is suppressed and/or in the lower reference range, compared to when TSH is in the upper reference range.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2003

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 25, 2005

Completed
Last Updated

June 24, 2005

Status Verified

May 1, 2005

First QC Date

May 24, 2005

Last Update Submit

June 23, 2005

Conditions

Hypothyroidism

Outcome Measures

Primary Outcomes (1)

  • Visual analog scales assessing wellbeing

Secondary Outcomes (5)

  • treatment satisfaction score

  • treatment preference

  • quality of life scores

  • cognitive function tests

  • clinical and biochemical markers of thyroid hormone action

Interventions

ThyroxineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects \>18 years of age
  • Primary hypothyroidism ≥6 months duration arising from autoimmune hypothyroidism, thyroidectomy or radioiodine treatment
  • Thyroxine dose ≥100 mcg/day
  • No change in thyroxine dose in past 2 months
  • Serum TSH of 0.1-4.8 mU/L
  • Adequate contraceptive measures for women of childbearing age

You may not qualify if:

  • Major systemic illness affecting quality of life or likely to affect participation in the study
  • Treatment with T3 currently or in past 2 months
  • History of thyroid cancer requiring suppression of TSH secretion by thyroxine
  • Ischaemic heart disease - previous myocardial infarction, angina or coronary artery revascularisation
  • Renal failure: serum creatinine \>135 micromol/L
  • Known liver disease with alkaline phosphatase or ALT \>2x upper limit of reference range
  • Bony fracture in past 3 months or Paget's disease of bone
  • Secondary (central) hypothyroidism or hypopituitarism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Hypothyroidism

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 24, 2005

First Posted

May 25, 2005

Study Start

April 1, 2003

Study Completion

March 1, 2005

Last Updated

June 24, 2005

Record last verified: 2005-05

Locations

AU(1)