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| Sponsored by: |
Eli Lilly and Company |
|---|---|
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00266656 |
Purpose
This is an extension study that will gather long-term data on the effect of early growth hormone (GH) treatment on adult height and other aspects of health and development in girls with Turner syndrome. The main purpose is to determine whether girls who received 2 years of GH treatment before 6 years of age achieve taller adult height than girls who were untreated during this time. The study will also look at middle ear and hearing function, and cognitive and behavioral development. Protocol completion is defined as attainment of height velocity less than or equal to 1.0 cm/year, or bone age greater than or equal to 15 years.
| Condition | Intervention | Phase |
|---|---|---|
|
Turner Syndrome |
Drug: Somatropin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Effect of Early Growth Hormone Treatment on Long-Term Growth and Skeletal Maturation in Girls With Turner Syndrome |
| Estimated Enrollment: | 88 |
| Study Start Date: | December 2005 |
| Estimated Study Completion Date: | November 2015 |
| Estimated Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: No Intervention
Control
|
|
|
2: Experimental
Humatrope
|
Drug: Somatropin
According to investigator's clinical practice and guided by the approved package insert
|
Eligibility| Ages Eligible for Study: | 4 Years to 20 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 |
| United States, California | |
| 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. | Active, not recruiting |
| Los Angeles, California, United States, 90027 | |
| United States, Colorado | |
| 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 |
| Denver, Colorado, United States, 80218 | |
| Contact: Eli Lilly | |
| United States, Connecticut | |
| 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 |
| Hartford, Connecticut, United States, 06106 | |
| Contact: Eli Lilly | |
| United States, Illinois | |
| 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 |
| Chicago, Illinois, United States, 60614 | |
| Contact: Eli Lilly | |
| United States, Indiana | |
| 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 |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Eli Lilly | |
| United States, Missouri | |
| 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 |
| Kansas City, Missouri, United States, 64108 | |
| Contact: Eli Lilly | |
| United States, North Carolina | |
| 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 |
| Chapel Hill, North Carolina, United States, 275999 | |
| Contact: Eli Lilly | |
| United States, Pennsylvania | |
| 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 |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Eli Lilly | |
| United States, Washington | |
| 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 |
| Seattle, Washington, United States, 98105 | |
| Contact: Eli Lilly | |
| 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 hrs) | Eli Lilly and Company |
More Information
| Responsible Party: | Eli Lilly and Company ( Chief Medical Officer ) |
| Study ID Numbers: | 10088, B9R-US-GDGH |
| Study First Received: | December 15, 2005 |
| Last Updated: | November 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00266656 |
| Health Authority: | United States: Food and Drug Administration |
|
Chromosomal abnormalities Genital dwarfism Gonadal Disorders Chromosome Disorders Endocrine System Diseases Sex Differentiation Disorders Monosomy X Turner Syndrome |
Gonadal dysgenesis Urogenital Abnormalities Genetic Diseases, Inborn Turner syndrome Ovarian dwarfism Endocrinopathy Congenital Abnormalities Gonadal Dysgenesis |
|
Pathologic Processes Disease Syndrome Sex Chromosome Disorders |
