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)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004835-72-GB

Enrollment

200

Registered

2005-02-17

Start date

2005-01-12

Completion date

Unknown

Last updated

2014-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth hormone deficiency in adult life

Interventions

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 Hormo

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: Active malignant disease Active Cushing's disease or active acromegaly Pregnancy Breast feeding Proliferative diabetic retinopathy Sensitivity to GH or it preservative

Design outcomes

Primary

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

Measure

Time frame

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

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026