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Growth and Metabolic Response to GH and GnRHa Treatment Versus GH Alone in Boys Born SGA.

This study has been completed.
Information provided by:
Rabin Medical Center Identifier:
First received: August 29, 2007
Last updated: July 13, 2010
Last verified: July 2010

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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Height measurements [ Time Frame: every 3 monthes, during all study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IGF-1 concentration [ Time Frame: every 6 monthes, during all study period ] [ Designated as safety issue: Yes ]
  • Hormone profile, Lipid and lipoprotein concentrations [ Time Frame: once a year during all study period ] [ Designated as safety issue: No ]
  • Prepubertal changes [ Time Frame: every 3 monthes during all study peiod ] [ Designated as safety issue: No ]
  • Bone age [ Time Frame: once a year, during all study period ] [ Designated as safety issue: No ]
  • quality of life questionnaire [ Time Frame: once a year, during all study period ] [ Designated as safety issue: No ]
  • Psychological questionnaire [ Time Frame: once a year, during all study peiod ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: May 2005
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
GH & GNRHa treatment
Drug: growth hormone and gonadotropin-releasing hormone agonist
GH & GNRHa treatment
Active Comparator: 2
GH treatment
Drug: growth hormone
GH treatment

  Show Detailed Description


Ages Eligible for Study:   9 Years to 13 Years   (Child)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Boys
  2. IUGR
  3. Ages 10-13
  4. height of at list 2.0 standard deviations below the mean height for chronological age and sex according to the 2000 standards from the Centers for Disease Control and Prevention (CDC)
  5. Prepubertal (tanner stage 1) at commencement of trail
  6. Peak GH above 10ng/ml in at least one provocative test for GH secretion 7.Signed informed consent

Exclusion Criteria:

  1. Growth retardation associated with malignancy, severe chronic disease, genetic syndromes and endocrine disorders
  2. Diabetes
  3. Treatment with any medical product which may interfere with GH effects
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00522743

Schnider children medical center
Petach-Tikva, Israel
Sponsors and Collaborators
Rabin Medical Center
Principal Investigator: Moshe Phillip, Professor Rabin Medical Center
  More Information

Responsible Party: Prof. Moshe Phillip, Rabin Medical Center Identifier: NCT00522743     History of Changes
Other Study ID Numbers: rmc073243ctil  SGA boys 3243 
Study First Received: August 29, 2007
Last Updated: July 13, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:

Additional relevant MeSH terms:
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on October 28, 2016