Arimidex in McCune Albright Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2015-08-31

Brief Summary

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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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Detailed Description

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Conditions

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McCune-Albright Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Arimidex 1 mg

Intervention Type DRUG

Arimidex (anastrozole) 1mg once daily by mouth

Interventions

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Arimidex 1 mg

Arimidex (anastrozole) 1mg once daily by mouth

Intervention Type DRUG

Eligibility Criteria

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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 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

Maximum Eligible Age

10 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No