A pilot study of replacement therapy with recombinant TSH in central hypothyroidism

• Conditions: Central Hypothyroidism which is due to deficiency of TSH caused by the disease, surgery or radiotherapy of the pituitary gland.

• Registration Number: EUCTR2007-005242-21-GB
• Lead Sponsor: THE CHRISTIE NHS FOUNDATION TRUST

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

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

- Age <20 or >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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.