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Glucocorticosteroid replacement therapy and fibrinolysis in hypopituitarism - Glucocorticoid replacement therapy and fibrinolysis

Phase 1
Conditions
Hypopituitarism
Registration Number
EUCTR2004-002056-34-GB
Lead Sponsor
Bradford Teaching Hospitals NHS Foundation Trust
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Not specified
Target Recruitment
15
Inclusion Criteria

Age >18 years
ACTH deficiency previously assessed by dynamic testing (eg. insulin stress test).
Currently taking replacement with hydrocotisone at optimal replacement dose.
prior written informed consent
Must be on stable dose of other pituitary replacement hormones where there is documented deficiency.
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects requiring systemic steroid therapy
Subjects taking high dose hormone replacement therapy or oral contraceptive tablets
Subjects who are currenlty pregnant or who have had a recent pregnancy or abortion
Subjects with known malignancy
Subjects with known coagulopathy
Subjects who are currently taking or who have recently taken anticoagulant therapy
Asian subjects and patients with diabetes millitus in whom abnormalities of the fibrinolytic system may exist.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: To compare and characterise the effect of different doses of glucocorticoid replacement therapy on fibrinolytic parameters.;Secondary Objective: N/A;Primary end point(s): Changes in fibrinolytic parameters eg. PAI-1, tPA
Secondary Outcome Measures
NameTimeMethod
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