Full Text View
Tabular View
No Study Results Posted
Related Studies
A Study to Evaluate Subjects With Turner Syndrome Treated With Growth Hormone
This study is currently recruiting participants.
Verified by Genentech, July 2008
First Received: November 24, 2004   Last Updated: July 14, 2008   History of Changes
Sponsored by: Genentech
Information provided by: Genentech
ClinicalTrials.gov Identifier: NCT00097552
  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 IV

Study Type: Observational
Study Design: Cohort, 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:


Further study details as provided by Genentech:

Biospecimen Retention:   None Retained

Biospecimen Description:

Study Start Date: May 1997
Estimated Study Completion Date: December 2099
  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

Contacts
Contact: Trial Information Support Line 800-723-6247

Locations
United States, California
Trial Information Support Line Recruiting
South San Francisco, California, United States, 94080
Contact     800-723-6247        
Sponsors and Collaborators
Genentech
Investigators
Study Director: Barbara Lippe, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers: 85-036, Substudy 9
Study First Received: November 24, 2004
Last Updated: July 14, 2008
ClinicalTrials.gov Identifier: NCT00097552     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Gonadal Disorders
Genital Dwarfism
Chromosome Disorders
Endocrine System Diseases
Ovarian Dwarfism
Hormones
Sex Differentiation Disorders
Monosomy X
Turner Syndrome
Urogenital Abnormalities
Genetic Diseases, Inborn
Endocrinopathy
Congenital Abnormalities
Gonadal Dysgenesis

Additional relevant MeSH terms:
Disease
Gonadal Disorders
Chromosome Disorders
Endocrine System Diseases
Sex Differentiation Disorders
Turner Syndrome
Pathologic Processes
Urogenital Abnormalities
Genetic Diseases, Inborn
Syndrome
Sex Chromosome Disorders
Congenital Abnormalities
Gonadal Dysgenesis

ClinicalTrials.gov processed this record on July 06, 2009