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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	30 June 2014
Main ID:	EUCTR2004-004835-72-GB
Date of registration:	17/02/2005
Prospective Registration:	No
Primary sponsor:	University of Birmingham
Public title:	A study to determine the effects of growth hormone (GH) replacement therapy on quality of life and cardiovascualr risk in GH deficient adults - Growth Hormone and Quality of Life (GroH-QoL)
Scientific title:	A study to determine the effects of growth hormone (GH) replacement therapy on quality of life and cardiovascualr risk in GH deficient adults - Growth Hormone and Quality of Life (GroH-QoL)
Date of first enrolment:	12/01/2005
Target sample size:	200
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-004835-72
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
Phase:

Countries of recruitment
United Kingdom

Contacts

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Affiliation:

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Key inclusion & exclusion criteria

Inclusion criteria:
Aged over 18
Able to provide informed consent
Severe GH deficiency in adult life
No GH replacement for six months
Other hormone therapy stable over preceding six months
Life expectancy > 15 months
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:
Active malignant disease
Active Cushing's disease or active acromegaly
Pregnancy
Breast feeding
Proliferative diabetic retinopathy
Sensitivity to GH or it preservative

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Growth hormone deficiency in adult life

Intervention(s)

Trade Name: Norditropin SimpleXx 5mg/1.5ml
Product Name: Norditropin SimpleXx 5mg/1.5ml
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Somatropin
Other descriptive name: Growth Hormone, GH
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 3.33-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): Quality of life determined using the Quality of Life Adult Growth Hormone Deficiency Assessment (QoL-AGHDA)

Main Objective: To determine the impact of growth hormone replacement therapy on quality of Life in adults with severe growth hormone deficiency

Secondary Objective: To determine the impact of growth hormone replacement therapy on markers of cardiovascualr risk and bone density in adults with severe growth hormone deficiency

Secondary Outcome(s)

Secondary ID(s)

UB-MedSci-001/2004

Source(s) of Monetary Support

Secondary Sponsor(s)

University Hospital Birmingham Foundation NHS Trust

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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