CompletedPhase 2

Arimidex in McCune Albright Syndrome

France, Germany40 participantsStarted 2002-08

Plain-language summary

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.

Who can participate

Age range10 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

The efficacy of study treatment will be assessed based on the change from baseline measurements relating to vaginal bleeding, bone age, and growth velocity

Timeframe: 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

Trial details

NCT IDNCT00055302

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-02

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