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A Study to Evaluate Subjects With Turner Syndrome Treated With Growth Hormone

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00097552
First Posted: November 25, 2004
Last Update Posted: November 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
November 24, 2004
November 25, 2004
November 14, 2012
May 1997
July 2010   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00097552 on ClinicalTrials.gov Archive Site
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A Study to Evaluate Subjects With Turner Syndrome Treated With Growth Hormone
Characterization of Subjects With Turner Syndrome Treated With Growth Hormone in the National Cooperative Growth Study (NCGS)
This study is a multicenter, open-label, observational, postmarketing surveillance study of Genentech growth hormone (GH) products in the treatment of girls with Turner syndrome in the United States and Canada.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Primary care clinic
Turner Syndrome
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1696
July 2010
July 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Are girls with Turner syndrome who are being or will be treated with Nutropin, Nutropin AQ, or Protropin
  • Are willing to keep follow-up appointments throughout study participation
  • Are girls with Turner syndrome who have submitted Form 4 upon discontinuation and may also submit Form 9

Exclusion Criteria:

  • Have Noonan syndrome
  • Subjects treated within the last 6 months with a non-Genentech GH preparation
  • Have closed epiphyses prior to NCGS enrollment
  • Have active neoplasia
Sexes Eligible for Study: Female
up to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00097552
85-036, Substudy 9
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Genentech, Inc.
Genentech, Inc.
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Study Director: Barbara Lippe, M.D. Genentech, Inc.
Genentech, Inc.
November 2012