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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00191360

Enrollment

Registered

2005-09-19

Start date

2003-01-31

Completion date

2006-05-31

Last updated

2007-11-06

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

Conditions

Adult Growth Hormone Deficiency

Brief summary

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

Interventions

DRUGSomatropin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Long-term safety of growth hormone replacement in adult patients with growth hormone deficiency	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026