Faslodex in McCune Albright Syndrome - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00278915

Purpose

The purpose of this study is to evaluate the safety, effectiveness and pharmacokinetics of a study drug called Faslodex (fulvestrant) in the treatment of progressive precocious puberty (early puberty) in girls with McCune-Albright syndrome (MAS).

Condition	Intervention	Phase
Puberty, Precocious McCune-Albright Syndrome	Drug: Fulvestrant	Phase II

Genetics Home Reference related topics: Melnick-Needles syndrome

Drug Information available for: Ici 182780

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Non-Comparative Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of Faslodex (Fulvestrant) in Girls With Progressive Precocious Puberty Associated With McCune-Albright Syndrome

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Change in annualized number of vaginal bleed days on treatment compared to baseline
Change in rate of increase in bone age and growth rate on treatment compared to baseline

Secondary Outcome Measures:

Change in Tanner Stage of breast and pubic hair
Change in predicted adult height (PAH) for girls over the age of six

Estimated Enrollment:	30
Study Start Date:	November 2005
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Intervention Details:

intramuscular injection

Eligibility

Ages Eligible for Study:	up to 10 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Females less than or equal to 10 years of age (prior to 11th birthday)
Diagnosis of McCune-Albright syndrome (MAS)
Progressive precocious puberty (PPP) associated with MAS

Exclusion Criteria:

Received any prior treatment for PPP associated with MAS with fulvestrant
Abnormal platelet count or liver function tests
Bleeding disorders
Long term anticoagulation therapy
Known hypersensitivity to any component of the study drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278915

Locations

United States, Alabama
Research Site
BIRMINGHAM, Alabama, United States
United States, California
Research Site
SACRAMENTO, California, United States
United States, Florida
Research Site
MIAMI, Florida, United States
United States, Indiana
Research Site
INDIANAPOLIS, Indiana, United States
United States, Louisiana
Research Site
NEW ORLEANS, Louisiana, United States
Research Site
BATON ROUGE, Louisiana, United States
United States, New York
Research Site
BRONX, New York, United States
United States, Pennsylvania
Research Site
PHILADELPHIA, Pennsylvania, United States
United States, Utah
Research Site
SALT LAKE CITY, Utah, United States
France
Research Site
LYON CEDEX, France
Research Site
MONTPELLIER, France
Research Site
PARIS, France
Research Site
BORDEAUX CEDEX, France
Germany
Research Site
ERLANGEN, Germany
Research Site
Osnabruck, Germany
Italy
Research Site
TURIN, Italy
Research Site
ROMA, Italy
Russian Federation
Research Site
MOSCOW, Russian Federation
Spain
Research Site
BARCELONA, Spain
United Kingdom
Research Site
GLASGOW, United Kingdom
Research Site
LONDON, United Kingdom
Research Site
LIVERPOOL, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Faslodex Medical Science Director, MD

AstraZeneca

More Information

Study ID Numbers:	D6992C00044, EUDRACT Number: 2005-004893-29
Study First Received:	January 17, 2006
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00278915
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Progressive Precocious Puberty
PPP
McCune-Albright Syndrome
MAS

Study placed in the following topic categories:

Fibrous dysplasia of bone
Puberty, Precocious
Gonadal Disorders
Fulvestrant
Fibrous Dysplasia of Bone
Osteochondrodysplasias
Precocious puberty
Endocrine System Diseases

Fibrous Dysplasia, Polyostotic
Bone Diseases
Fibrous dysplasia
Musculoskeletal Diseases
Bone Diseases, Developmental
McCune Albright syndrome
Endocrinopathy

Additional relevant MeSH terms:

Estrogen Receptor Modulators
Estrogen Antagonists
Pathologic Processes
Disease
Antineoplastic Agents, Hormonal
Antineoplastic Agents

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

ClinicalTrials.gov processed this record on January 16, 2009