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

Phase 3CompletedNCT00191360

Eli Lilly and Company68 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Adult Growth Hormone Deficiency

Interventions

SomatropinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (14)

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

Data from ClinicalTrials.gov

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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

Fukuoka, Japan

Gunma, Japan

Hokkaido, Japan

Hyōgo, Japan

Ishikawa, Japan

Kumamoto, Japan

Kyoto, Japan

Miyazaki, Japan

Nagano, Japan

Okayama, Japan

...and 4 more locations