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Clinical Trials/NCT00191360
NCT00191360
Completed
Phase 3

Extended Clinical Study of LY137998 [Somatropin (Recombinant DNA Origin)] in Adults With Growth Hormone Deficiency

Eli Lilly and Company1 site in 1 country68 target enrollmentJanuary 2003
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ConditionsAdult Growth Hormone Deficiency
DrugsSomatropin

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Adult Growth Hormone Deficiency
Sponsor
Eli Lilly and Company
Enrollment
68
Locations
1
Primary Endpoint
Long-term safety of growth hormone replacement in adult patients with growth hormone deficiency
Status
Completed
Last Updated
18 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
January 2003
End Date
May 2006
Last Updated
18 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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

Study Sites (1)

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