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Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature (Phoenix)
This study is currently recruiting participants.
Verified by Eli Lilly and Company, January 2010
First Received: July 18, 2006   Last Updated: January 22, 2010   History of Changes
Sponsor: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00355030
  Purpose

The present randomized trial intends to study the benefits of a combined treatment with GH and a GnRH agonist for increasing growth during puberty.

Study will test the hypothesis that combined treatment with somatropin until adult height is reached and leuprorelin every three months for three years in pubertal children with idiopathic short stature results in a greater adult height, expressed in standard deviation score (SDS), than treatment with somatropin alone until adult height is reached.


Condition Intervention Phase
Idiopathic Short Stature (ISS)
 Drug: somatropin
Drug: leuprorelin
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: Efficacy and Safety of Somatropin in Combination With Leuprorelin Compared to Somatropin Alone in Pubertal Children With Idiopathic Short Stature

Resource links provided by NLM:

Drug Information available for: Somatropin Somatotropin
U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Adult height reached, expressed in SDS for adult height [ Time Frame: 2015 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Annual height velocities [ Time Frame: 2015 ] [ Designated as safety issue: No ]
  • Annual Height SDS [ Time Frame: 2015 ] [ Designated as safety issue: No ]
  • Difference between adult height SDS and target height SDS [ Time Frame: 2015 ] [ Designated as safety issue: No ]
  • Difference between adult height SDS and Predicted height SDS [ Time Frame: 2015 ] [ Designated as safety issue: No ]
  • Bone age [ Time Frame: 2015 ] [ Designated as safety issue: No ]
  • Lumbar bone mineral density ( Height Adjusted Z score) [ Time Frame: annually ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 88
Study Start Date: June 2006
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: somatropin
0.05 mg/kg/day
Drug: leuprorelin
11.25 mg/3 months
2: Experimental Drug: somatropin
0.05 mg/kg/day

  Eligibility

Ages Eligible for Study:   8 Years to 171 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female children with ISS
  • age less than or equal to 8 years and less than 12 years and 3 months for girls and less than or equal to 9 years and less than 14 years and 3 months for boys
  • bone age less than or equal to 12.0 years for girls and less than or equal to 14.0 years for boys based on a central reading of an X-ray of the left hand and wrist
  • Pubertal stage B2 and B3 for girls based on the Tanner method
  • Pubertal stage G2 and G3 for boys based on the Tanner method

Exclusion Criteria:

  • Growth hormone deficiency (GHD)
  • Chromosomal abnormality diagnosed locally on a karyotype. For girls, the karyotype, to eliminate a Turner syndrome, is mandatory
  • Small for gestational age (SGA)
  • Has reached menarche (had her first menstrual period)
  • Have any significant concomitant disease that is likely to interfere with growth or with the study, or is a known contraindication to Growth Hormone treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00355030

Contacts
Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

Locations
France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Amiens, France, 80084
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Besancon, France, 25030
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Bordeaux, France, 33076
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Boulogne, France, 92100
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Nice, France, 06200
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Lille, France, 59037
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Lyon, France, 69322
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Marseille, France, 13385
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Le Havre, France, 76083
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Paris, France, 75743
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Reims, France, 51092
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Rennes, France, 35056
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Rouen, France, 76036
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Saint-Etienne, France, 42055
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Strasbourg, France, 67 098
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Toulouse, France, 31026
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Tarbes, France, 65000
Contact: Eli Lilly            
Netherlands
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Nijmegen, Netherlands, 6525 GM
Contact: Eli Lilly            
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Rotterdam, Netherlands, 3015 GD
Contact: Eli Lilly            
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Eli Lilly ( Chief Medical Officer )
Study ID Numbers: 9861, B9R-FP-GDGI
Study First Received: July 18, 2006
Last Updated: January 22, 2010
ClinicalTrials.gov Identifier: NCT00355030     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Leuprolide
Fertility Agents, Female
Therapeutic Uses
 Physiological Effects of Drugs
Fertility Agents
Reproductive Control Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010



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