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Completed

NCT Number: NCT00406926

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

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.

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Key information

Age range

9 month–4 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Somatropin

Drug

Primary outcomes

  1. Height at the end of two years in the study.

Secondary outcomes

  1. Middle ear problems assessed every 4 months

  2. Hearing problems assessed annually

  3. Cognitive and behavioral development assessed annually

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

The Effect of Recombinant Human Growth Hormone Treatment on the Growth of Infants and Toddlers With Turner Syndrome

Important dates

Study start
1999
Study completion
2003
First posted
Dec 4, 2006
Registry last updated
Dec 4, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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