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:

Genetics Home Reference related topics: Turner syndrome

MedlinePlus related topics: Turner Syndrome

U.S. FDA Resources

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