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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00097552
First received: November 24, 2004
Last updated: November 13, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Phase
Turner Syndrome
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Subjects With Turner Syndrome Treated With Growth Hormone in the National Cooperative Growth Study (NCGS)

Resource links provided by NLM:

MedlinePlus related topics: Turner Syndrome
U.S. FDA Resources

Further study details as provided by Genentech:

Enrollment: 1696
Study Start Date: May 1997
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00097552

Sponsors and Collaborators
Genentech
Investigators
Study Director: Barbara Lippe, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00097552     History of Changes
Other Study ID Numbers: 85-036, Substudy 9
Study First Received: November 24, 2004
Last Updated: November 13, 2012
Health Authority: United States: Institutional Review Board

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
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013