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Arimidex in Girls with McCune-Albright Syndrome
NCT00055302Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2002
- Primary completion
- Feb 2006
- Countries
- 4
- Sponsor
- AstraZeneca
- Modality
- Irreversible Covalent Inhibitors, Orthosteric Ligands
- Drugs
- anastrozole
- Conditions
- McCune-Albright syndrome (MAS)
01
Overview
Phase 2, open-label, single-arm trial of anastrozole in McCune-Albright syndrome (MAS), sponsored by AstraZeneca. Primary endpoints: Change from baseline in vaginal bleeding at 12 months, Change from baseline in bone age at 12 months and 1 more. Started Aug 2002; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Arimidex 1 mg
Arimidex (anastrozole) 1mg once daily by mouth
03
Who it enrols
Females <= 10 years with McCune-Albright Syndrome and progressive precocious puberty, excluding those with prior non-responsive treatment with 3rd generation aromatase inhibitors.
04
Endpoints
Primary
Change from baseline in vaginal bleeding
Change from baseline in bone age
Change from baseline in growth velocity
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