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Faslodex in McCune-Albright Syndrome

NCT00278915 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-03-05

Study results available
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Summary

The purpose of this study is to evaluate the safety, effectiveness and pharmacokinetics of a study drug called Faslodex (fulvestrant) in the treatment of progressive precocious puberty (PPP) (early puberty) in girls with McCune-Albright syndrome (MAS)

Conditions

  • Puberty, Precocious
  • McCune-Albright Syndrome

Interventions

DRUG

Fulvestrant

Participants will receive intramuscular injection of fulvestrant as stated in arm description.

Sponsors & Collaborators

Principal Investigators

  • AstraZeneca Faslodex Medical Science Director, MD · AstraZeneca

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
10 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2009-12-08
Completion
2023-07-20

Countries

  • United States
  • France
  • Germany
  • Italy
  • Russia
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00278915 on ClinicalTrials.gov