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OpenTrials
Completed

NCT Number: NCT00055302

Arimidex in McCune Albright Syndrome

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.

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Key information

Conditions

McCune-Albright Syndrome Bone Diseases Bone Diseases, Developmental Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrous Dysplasia of Bone Fibrous Dysplasia, Polyostotic Genital Diseases Genital Diseases, Female Hemorrhage Musculoskeletal Diseases Osteochondrodysplasias Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

Up to 10 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Montpellier, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arimidex 1 mg

Drug

Arimidex (anastrozole) 1mg once daily by mouth

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2006
Study completion
2015
First posted
Feb 26, 2003
Registry last updated
Sep 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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