Not Signed In -
Turner syndrome |
45,X; Bonnevie-Ullrich Syndrome; monosomy X; TS; Turners Syndrome; Ullrich-Turner syndrome |
Clinical Trial: Long-Term Growth and Skeletal Effects of Early Growth Hormone Treatment in Turner Syndrome
This study is not yet open for patient recruitment.
Verified by Eli Lilly and Company December 2005
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Purpose
This is an extension study that will gather long-term data on the effect of early growth hormone treatment on adult height and other important health aspects in girls with Turner syndrome. The main purpose is to study the effect that two years of early childhood growth hormone treatment has on adult height. The study will also look at middle ear and hearing function, and cognitive and behavioral development.
| Condition | Intervention | Phase |
|---|---|---|
| Turner Syndrome | Drug: Somatropin Drug: No somatropin | Phase IV |
MedlinePlus related topics: Turner''''s Syndrome
Genetics Home Reference related topics: Turner syndrome
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Effect of Early Growth Hormone Treatment on Long-Term Growth and Skeletal Maturation in Girls With Turner Syndrome
Further study details as provided by Eli Lilly and Company:
Primary Outcomes: Adult height at the end of growth.
Secondary Outcomes: Height SDS at various ages.; Age at attainment of Tanner 2 breast development.; Age at attainment of near-final height.; Percentage of subjects for whom serious adverse events are reported.; Percentage of subjects for whom certain adverse events are reported.; Percentage of subjects with abnormal audiometry results at certain ages.
Expected Total Enrollment: 88
Secondary Outcomes: Height SDS at various ages.; Age at attainment of Tanner 2 breast development.; Age at attainment of near-final height.; Percentage of subjects for whom serious adverse events are reported.; Percentage of subjects for whom certain adverse events are reported.; Percentage of subjects with abnormal audiometry results at certain ages.
Expected Total Enrollment: 88
Study start: December 2005; Expected completion: November 2015
Eligibility
Ages Eligible for Study: 4 Years - 20 Years, Genders Eligible for Study: Female
Criteria
Inclusion Criteria:
- Previously randomized in study B9R-US-GDFG
- Karyotype-proven Turner syndrome
Exclusion Criteria:
- Immediate family members of study site personnel directly affiliated with the study
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00266656
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559
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., Los Angeles, California, United States
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., Stanford, California, United States
Eli Lilly
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., Denver, Colorado, United States
Eli Lilly
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., Hartford, Connecticut, United States
Eli Lilly
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., Chicago, Illinois, United States
Eli Lilly
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., Indianapolis, Indiana, United States
Eli Lilly
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., Kansas City, Missouri, United States
Eli Lilly
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., Chapel Hill, North Carolina, United States
Eli Lilly
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., Philadelphia, Pennsylvania, United States
Eli Lilly
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., Seattle, Washington, United States
Eli Lilly
Study chairs or principal investigators
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), Study Director, Eli Lilly and Company
More Information
Study ID Numbers: 10088
Last Updated: December 16, 2005
Record first received: December 15, 2005
ClinicalTrials.gov Identifier: NCT00266656
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10
Last Updated: December 16, 2005
Record first received: December 15, 2005
ClinicalTrials.gov Identifier: NCT00266656
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10
Resources
- (National Women's Health Information Center, OWH, HHS)
- AACE Physician Finder (American Association of Clinical Endocrinologists)
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