NCT01605331

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2012

Completed
Last Updated

October 5, 2012

Status Verified

October 1, 2012

Enrollment Period

9 months

First QC Date

May 22, 2012

Last Update Submit

October 3, 2012

Conditions

Growth Hormone Deficiency

Keywords

AdultsGH deficiency

Outcome Measures

Primary Outcomes (1)

  • Safety

    Adverse event

    12 weeks

Secondary Outcomes (1)

  • Efficacy

    12 weeks

Study Arms (1)

sustained-release recombinant human GH (SR-rhGH)

EXPERIMENTAL

12-week subcutaneous administration, 2mg/week

Drug: sustained-release recombinant human GH (SR-rhGH)

Interventions

sustained-release recombinant human GH (SR-rhGH)DRUG
sustained-release recombinant human GH (SR-rhGH)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2012

First Posted

May 24, 2012

Study Start

December 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

October 5, 2012

Record last verified: 2012-10