Safety and Efficacy of SR-hGH (Sustained-release Human Growth Hormone, Declage Inj.)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01605331

Enrollment

132

Registered

2012-05-24

Start date

2009-12-31

Completion date

2010-09-30

Last updated

2012-10-05

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

Conditions

Growth Hormone Deficiency

Keywords

Adults, GH deficiency

Brief summary

As studies demonstrate, the administration of recombinant human GH (rhGH) in adults with GH deficiency has been known to improve metabolic impairment and quality of life. Patients, however, do have to tolerate daily injections of GH (rhGH).

Interventions

DRUGsustained-release recombinant human GH (SR-rhGH)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Men and women aged ≥ 20 years with diagnosed GH deficiency (caused by pituitary tumor, trauma, other pituitary disease)

Design outcomes

Primary

Measure	Time frame	Description
Safety	12 weeks	Adverse event

Secondary

Measure	Time frame	Description
Efficacy	12 weeks	QoL-AGHDA

Outcome results

None listed

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