Central Hypothyroidism which is due to deficiency of TSH caused by the disease, surgery or radiotherapy of the pituitary gland.
Conditions
Interventions
Trade Name: THYROGEN
Pharmaceutical Form: Powder and solvent for solution for injection
Sponsors
THE CHRISTIE NHS FOUNDATION TRUST
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged between 20 and 60 years suffering from hypothyroidism due to hypopituitarism with their thyroid function showing low freeT4 and undetectable TSH will be included. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Age 60 years - Inability to give informed consent - Thyrotoxicosis - Severe concomitant illness with significant impact on life expectancy - Active acromegaly or Cushing's disease - Cardiac arrhythmias or ischaemic heart disease - Treatment with Amiodarone or Lithium within the last 6 months - Current treatment with: L-Tri-iodothyronine, Carbimazole, Propylthiouracil or HRT. - Pregnancy - Breast feeding - Women in child bearing age planning pregnancy - Hypersensitivity to bovine or human thyroid stimulating hormone or to any of the excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To find out the efficacy and safety of very low dose recombinant TSH given subcutaneously on alternate days for treating central hypothyroidism.;Secondary Objective: To learn about immediate effects of TSH replacement therapy on blood flow to the thyroid, thyroid size, iodine excretion, bone markers and on fat cells. ;Primary end point(s): Thyroid function - freeT4, T3,TSH and thyroglobulin. | — |
Countries
United Kingdom
Outcome results
None listed