Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency

Phase III of the Comparative Study on the Efficacy and Safety of Recombinant Somatropin Administered to Patients With Adult Growth Hormone Deficiency

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02693522

Enrollment

Registered

2016-02-26

Start date

2003-10-31

Completion date

2004-12-31

Last updated

2016-02-29

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

Conditions

Growth Hormone Deficiency

Brief summary

The purpose of this study is to evaluate the efficacy and safety of recombinant human growth hormone on adult growth hormone deficiency

Interventions

DRUGsomatropin

Subcutaneous injection

DRUGEutropin

Subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients aged 18 and up * Patients with maximum serum growth hormone concentration of less than 5 ng/ml * Patients who can successfully complete this study based on appropriate medical judgment or who expect to benefit from this study * Persons who have agreed in writing to participate in this study

Exclusion criteria

* Persons who are currently under treatment after being diagnosed with a malignant tumor * Hepatosis * Renal function disorder * Intra-cranial hypertension * Proliferative diabetic retinopathy * Persons who carry acromegaly activity * Fertile women who are not pregnant or who do not take appropriate contraceptive measures and whose urine tested positive for hCG (human Chorionic Gonadotropin) * Mental patients and/or drug addicts and alcoholics * Patients who had participated in the other drug study within the last 30 days prior to participating in this study * Patients considered unfit for this study by the attending physician

Design outcomes

Primary

Measure	Time frame	Description
Degree of fat mass (FM) reduction	baseline and 24 weeks	statistically difference for change from baseline (kg)

Secondary

Measure	Time frame	Description
Degree of variation in Lean Body Mass	baseline and 24 weeks	statistically difference for change from baseline (kg)
Degree of variation in Waist to Hip Ratio	baseline and 24 weeks	statistically difference for change from baseline
Degree of variation in IGF-1	baseline and 24 weeks	statistically difference for change from baseline (ng/ml)

Countries

South Korea

Outcome results

None listed

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