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Sponsored by: |
Rabin Medical Center |
---|---|
Information provided by: | Rabin Medical Center |
ClinicalTrials.gov Identifier: | NCT00522743 |
A 2-arms randomized open prospective intervention study to determine the Growth and metabolic response to growth hormone and gonadotropin-releasing hormone agonist treatment versus growth hormone alone in boys born SGA.
All subjects will be treated with NorditropinSimplex at a dosage of 100mcg/kg/d.
At onset of puberty, subjects will be randomized into either combined treatment with GH and GnRHa or GH alone.
Condition | Intervention |
---|---|
SGA and Growth |
Drug: growth hormone and gonadotropin-releasing hormone agonist Drug: growth hormone |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Two Arms, Open, Controlled, Prospective, Intervention Study to Evaluate the Growth and Metabolic Response to Growth Hormone and Gonadotropin-Releasing Hormone Agonist Treatment Versus Growth Hormone Alone in Boys Born SGA |
Enrollment: | 17 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
GH & GNRHa treatment
|
Drug: growth hormone and gonadotropin-releasing hormone agonist
GH & GNRHa treatment
|
2: Active Comparator
GH treatment
|
Drug: growth hormone
GH treatment
|
Ages Eligible for Study: | 9 Years to 13 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Rabin Medical Center ( Prof. Moshe Phillip ) |
Study ID Numbers: | rmc073243ctil, SGA boys 3243 |
Study First Received: | August 29, 2007 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00522743 |
Health Authority: | Israel: Ministry of Health |
SGA GH GnRHa IGF-1 |