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

Turner Syndrome Clinical Trial

Official title:

Characterization of Subjects With Turner Syndrome Treated With Growth Hormone in the National Cooperative Growth Study (NCGS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097552
• Other study ID #: 85-036, Substudy 9
• Status: Completed
• Phase: Phase 4
• First received: November 24, 2004
• Last updated: November 13, 2012
• Start date: May 1997
• Est. completion date: July 2010

Study information

• Verified date: November 2012
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1696
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 17 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gonadal Dysgenesis
• Primary Ovarian Insufficiency
• Syndrome
• Turner Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.