Clinical Trial: Arimidex in McCune Albright Syndrome


	Home	\|	Search	\|	Browse	\|	Resources	\|	Help	\|	What's New	\|	About

Arimidex in McCune Albright Syndrome

This study is currently recruiting patients.

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca

Purpose

The primary objective of this study is to evaluate the safety and efficacy of anastrozole 1 mg given once daily in subjects with McCune-Albright Syndrome.

Condition	Treatment or Intervention	Phase
McCune-Albright Syndrome	Drug: Arimidex 1 mg	Phase II

MedlinePlus related topics: Bone Diseases

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title: An Open-label Study Evaluating the Safety and Efficacy of Anastrozole™ (ARIMIDEX) in the Treatment of Precocious Puberty in girls with McCune-Albright Syndrome

Eligibility

Ages Eligible for Study: up to 10 Years, Genders Eligible for Study: Female

Criteria

Inclusion Criteria:

informed written consent of parent/legal guardian and subject assent (as needed by local requirements)
females less than or equal to 10 years of age
diagnosed with McCune-Albright Syndrome
have progressive precocious puberty

Exclusion Criteria: Any one of the following is regarded as a criterion for exclusion from the study:

any prior treatment of MAS associated with progressive precocious puberty with a third generation aromatase inhibitor (anastrozole, letrozole, exemestane) in which no clinical response was seen
concomitant treatment of precocious puberty associated with MAS, with the exception of bisphosphonates for polyostotic fibrous dysplasia and LHRH analogues in the case of central precocious puberty
liver function tests at screening visit (AST, ALT) > or = 3x the upper limit of the reference range for age
known hypersensitivity to any component of study medication

Location and Contact Information

AstraZeneca Information Center Telephone: 800-236-9933, (US - 8a-7p EST) 001-800-236-9933 (Outside US) www.astrazeneca-us.com/contactus

California
Sacramento, California, United States; Recruiting

Florida
Tallahassee, Florida, United States; Recruiting

Maryland
Baltimore, Maryland, United States; Recruiting

Ohio
Cincinnati, Ohio, United States; Recruiting

Oregon
Portland, Oregon, United States; Recruiting

France
Montpellier, France; Recruiting

Paris, France; Recruiting

Germany
Osnabrueck, Germany; Recruiting

Erlangen, Germany; Recruiting

Berlin, Germany; Recruiting

Italy
Torino, Italy; Recruiting

Spain
Madrid, Spain; Recruiting

Barcelona, Spain; Recruiting

United Kingdom
Manchester, United Kingdom; Recruiting

London, United Kingdom; Recruiting

More Information

Study ID Numbers: 1033IL/0046
Record last reviewed: October 2003
Record first received: February 25, 2003
ClinicalTrials.gov Identifier: NCT00055302
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-29

U.S. National Library of Medicine, Contact NLM Customer Service

National Institutes of Health, Department of Health & Human Services