Extension Study on Safety of Long-Term Growth Hormone Replacement in Adult Patients With Growth Hormone Deficiency

Phase 3

Completed

• Conditions: Adult Growth Hormone Deficiency

• Registration Number: NCT00191360
• Lead Sponsor: Eli Lilly and Company

Brief Summary

To evaluate long-term safety of growth hormone replacement in adult patients with growth hormone deficiency

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2006-05
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-05
• Last Update Posted: 2007-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Having completed the preceding long-term study of growth hormone replacement in adult patients diagnosed with growth hormone deficiency.
• Other pituitary hormone deficiencies being replaced if appropriate

Exclusion Criteria

• With severe impairments of cardiac, pulmonary, renal or hepatic functions
• With severe psychological disorders
• With malignant cancer
• With hypertension uncontrolled
• With diabetes mellitus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Long-term safety of growth hormone replacement in adult patients with growth hormone deficiency

Secondary Outcome Measures

Name	Time	Method
Maintenance of efficacy of growth hormone replacement, measured by lean body mass, which is achieved in the previous trial in adult patients wtih growth hormone deficiency

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician; 🇯🇵 Tokyo, Japan