The Effect of Growth Hormone in Very Young Girls With Turner Syndrome

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00406926
First received: November 29, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  Purpose

This study investigated the effect of growth hormone on the growth of infants and toddlers with Turner syndrome during 2 years of treatment with growth hormone. This was compared with the growth of infants and toddlers with Turner syndrome who did not receive any growth hormone treatment. The overall aim was to prevent the growth failure usually seen during this period. The study also looked at middle ear disease, hearing problems, and cognitive and behavioral development.


Condition Intervention Phase
Turner Syndrome
Drug: Somatropin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Recombinant Human Growth Hormone Treatment on the Growth of Infants and Toddlers With Turner Syndrome

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Height at the end of two years in the study.

Secondary Outcome Measures:
  • Middle ear problems assessed every 4 months
  • Hearing problems assessed annually
  • Cognitive and behavioral development assessed annually

Estimated Enrollment: 100
Study Start Date: August 1999
Estimated Study Completion Date: August 2003
  Eligibility

Ages Eligible for Study:   9 Months to 4 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Karyotype-proven Turner syndrome that included a documented abnormality of the short arm of an X chromosome.
  • At least 9 months of age and not greater than 4 years of age.
  • Normal values for age for hemoglobin, thyroid stimulating hormone (TSH) and urinalysis (office dipstick is adequate), performed prior to study entry.
  • If there was a known history of hypothyroidism, then adequate thyroid hormone replacement must have been taken for at least 6 months prior to study entry.

Exclusion Criteria:

  • Current or previous treatment with any therapy that may have directly influenced growth, including growth hormone, growth hormone-releasing hormone, estrogens and anabolic steroids such as oxandrolone. This included previous completion of, or withdrawal from, this study or any other study investigating therapeutic uses of growth hormone or growth hormone-releasing hormone.
  • Chronic treatment with systemic glucocorticoids in supra-physiological doses.
  • Treatment with potential growth-influencing medications such as methylphenidate (Ritalin), pemoline (Cylert), and amphetamines, at, or within 3 months prior to, study entry.
  • Presence of any Y chromosome component in the karyotype if gonads were in situ. Subjects whose karyotype contained Y chromatin, but who had undergone gonadectomy, were eligible to enter the study.
  • Presence of any additional known autosomal abnormality.
  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 ClinicalTrials.gov identifier: NCT00406926

Locations
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.
Los Angeles, California, United States, 90027
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, 94305
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.
Denver, Colorado, United States, 80218
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.
Hartford, Connecticut, United States, 06106
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.
Chicago, Illinois, United States, 60614
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.
Indianapolis, Indiana, United States, 46202
United States, Kentucky
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.
Lexington, Kentucky, United States, 40536
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.
Kansas City, Missouri, United States, 64108
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.
Philadelphia, Pennsylvania, United States, 19107
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.
Seattle, Washington, United States, 98105
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

No publications provided

ClinicalTrials.gov Identifier: NCT00406926     History of Changes
Other Study ID Numbers: 2878, B9R-US-GDFG
Study First Received: November 29, 2006
Last Updated: November 29, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 18, 2014