Faslodex in McCune Albright Syndrome - FMAS

Study identifier:D6992C00044

ClinicalTrials.gov identifier:NCT00278915

EudraCT identifier:N/A

CTIS identifier:N/A

Recruitment Complete

Official Title

An Open-label, Non-Comparative Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of Faslodex (fulvestrant) in Girls with Progressive Precocious Puberty Associated with McCune-Albright Syndrome

Medical condition

Puberty, Precocious, McCune-Albright Syndrome

Phase

Phase 2

Healthy volunteers

No

Study drug

Fulvestrant

Sex

Female

Actual Enrollment

30

Study type

Interventional

Age

1 Years - 10 Years

Date

Study Start Date: 31 Jan 2006
Primary Completion Date: 08 Dec 2009
Estimated Study Completion Date: 30 Jun 2023

Study design

Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2022 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria