This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Arimidex in McCune Albright Syndrome

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: February 25, 2003
Last updated: August 31, 2015
Last verified: August 2015
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 Intervention Phase
McCune-Albright Syndrome Drug: Arimidex 1 mg Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The efficacy of study treatment will be assessed based on the change from baseline measurements relating to vaginal bleeding, bone age, and growth velocity [ Time Frame: 12 months or until the subject demonstrates the lack of efficacy bases upon progression of primary endpoints or experiences serious drug-related toxicity requiring withdrawal ]

Enrollment: 40
Study Start Date: August 2002
Study Completion Date: August 2015
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Arimidex 1 mg
Arimidex (anastrozole) 1mg once daily by mouth


Ages Eligible for Study:   up to 10 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00055302

Research Site
Montpellier, France
Research Site
Paris, France
Research Site
Berlin, Germany
Research Site
Erlangen, Germany
Research Site
Osnabrück, Germany
Research Site
Torino, Italy
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
Study Director: AstraZeneca Arimidex Medical Science Director, MD AstraZeneca
  More Information

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT00055302     History of Changes
Other Study ID Numbers: 1033IL/0046
Study First Received: February 25, 2003
Last Updated: August 31, 2015

Keywords provided by AstraZeneca:
vaginal bleeding
advanced bone age
fibrous dysplasia
McCune-Albright Syndrome

Additional relevant MeSH terms:
Fibrous Dysplasia, Polyostotic
Pathologic Processes
Fibrous Dysplasia of Bone
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on September 19, 2017