Initiating Transdermal Estradiol Therapy in Turner's Syndrome - Full Text View

Sponsor:	University of Chicago
Collaborators:	Novo Nordisk University of Michigan Johns Hopkins University Massachusetts General Hospital University of Oklahoma University of South Florida Thomas Jefferson University
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00870220

Purpose

This is a multicenter, randomized, controlled, semi-blinded study to compare two low doses of estradiol administered by recently available transdermal patches for the initiation of puberty in Turner syndrome girls 11.5-13.0 years old in conjunction with growth hormone (GH) therapy.

The specific hypotheses to be tested are: when combined with growth hormone (GH) treatment, low dose transdermal estradiol (LTE2) replacement will be more effective in stimulating feminization, height velocity, and bone mineral density without compromising growth potential than very low dose transdermal estradiol (VLTE2), which will in turn be superior to GH alone in effects on feminization, height velocity, and bone mineral density.

Condition	Intervention
Turner's Syndrome	Drug: Norditropin, Menostar 14mcg patch, Vivelle dot 25mcg patch

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Initiating Transdermal Estradiol Therapy in Turner's Syndrome

Resource links provided by NLM:

Genetics Home Reference related topics: 17q21.31 microdeletion syndrome persistent Müllerian duct syndrome tetrasomy 18p Turner syndrome

MedlinePlus related topics: Turner Syndrome

Drug Information available for: Estradiol Estradiol 3-benzoate Somatropin Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate Somatotropin

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

The net change of height velocity between Group 2 and Group 3 and the net change in predicted height between Group 2 and Group 3. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Plasma E2 level to document the dose-response effect of the applied prescription and uterine dimensions to quantitate the estrogenic effect on growth and development of the uterus. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	April 2009
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: GH alone, Low dose E2 patch, Very Low-dose E2 patch Group 1: Growth hormone alone, no E2. Group 2: Growth Hormone plus Estradiol patch dose A(14 mcg/d x 10 d) x 6 months then Estradiol patch dose B(25 mcg/d x 10 d) x 6 months. Group 3: Growth Hormone plus Estradiol patch dose B(25 mcg/d x 10 d) x 6 months then Estradiol patch dose C(25 mcg/d x 3 w) x 6 months.	Drug: Norditropin, Menostar 14mcg patch, Vivelle dot 25mcg patch GH will be maintained at 0.05mg/kg/d, adjusted every 3 months. Estradiol 14mcg patch will be applied for 10 days/month for the first 6 months in Group 2. Estradiol 25mcg patch will be applied for 10 days/month for the second 6 months in Group 2, and for the first 6 months in Group 3. Estradiol 25mcg patch will be applied for 3 weeks per month for the second 6 months in Group 3. Other Names: Norditropin Menostar patch Vivelle dot patch

Arms

Assigned Interventions

Experimental: GH alone, Low dose E2 patch, Very Low-dose E2 patch

Group 1: Growth hormone alone, no E2. Group 2: Growth Hormone plus Estradiol patch dose A(14 mcg/d x 10 d) x 6 months then Estradiol patch dose B(25 mcg/d x 10 d) x 6 months.

Group 3: Growth Hormone plus Estradiol patch dose B(25 mcg/d x 10 d) x 6 months then Estradiol patch dose C(25 mcg/d x 3 w) x 6 months.

Drug: Norditropin, Menostar 14mcg patch, Vivelle dot 25mcg patch

GH will be maintained at 0.05mg/kg/d, adjusted every 3 months. Estradiol 14mcg patch will be applied for 10 days/month for the first 6 months in Group 2. Estradiol 25mcg patch will be applied for 10 days/month for the second 6 months in Group 2, and for the first 6 months in Group 3. Estradiol 25mcg patch will be applied for 3 weeks per month for the second 6 months in Group 3.

Other Names:

Norditropin
Menostar patch
Vivelle dot patch

Show Detailed Description

Eligibility

Ages Eligible for Study:	138 Months to 13 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

60 subjects will be recruited from participating Pediatric Endocrinology Clinics in the United States.
Subjects will be 11.5-13.0 years of age and must have completed at least 6 months of GH therapy prior to the study.
Subjects may not have had any estrogen prior to the study. All subjects must be breast stage 1 and euthyroid prior to the study
Those on thyroid medication will continue the appropriate thyroid replacement therapy during the study.

Exclusion Criteria:

On estrogen therapy, breast stage 2 or greater, not on GH for at least 6 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870220

Contacts

Contact: Robert L. Rosenfield, MD	773-702-6432 ext 5-4453	robros@peds.bsd.uchicago.edu
Contact: Nancy A. Devine, BSN, RN	773-702-6432 ext 5-4417	ndevine@peds.bsd.uchicago.edu

Locations

United States, Illinois
University of Chicago	Recruiting
Chicago, Illinois, United States, 60637
Contact: Robert L Rosenfield, MD 773-702-6432 ext 5-4453 robros@peds.bsd.uchicago.edu
Contact: Nancy A Devine, RN, BSN 773-702-6432 ext 5-4417 ndevine@peds.bsd.uchicago.edu
Principal Investigator: Robert L Rosenfield, MD
Sub-Investigator: Christine Yu, MD
United States, Maryland
John Hopkins University	Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: David Cooke, MD 410-955-6463
Principal Investigator: David Cooke, MD
United States, Michigan
University of Michigan	Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Josephine Z Kasa-Vubu, MD, MS 734-764-5175 jzkv@umich.edu
Principal Investigator: Josephine Z Kasa-Vubu, MD, MS

Sponsors and Collaborators

University of Chicago

Novo Nordisk

University of Michigan

Johns Hopkins University

Massachusetts General Hospital

University of Oklahoma

University of South Florida

Thomas Jefferson University

Investigators

Principal Investigator:

Robert L. Rosenfield, MD

University of Chicago

More Information

No publications provided

Responsible Party:	Robert L. Rosenfield, M.D., University of Chicago
ClinicalTrials.gov Identifier:	NCT00870220 History of Changes
Other Study ID Numbers:	15327B
Study First Received:	March 5, 2009
Last Updated:	April 9, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Chicago:

Turner's Syndrome

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
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents

ClinicalTrials.gov processed this record on February 09, 2012