Faslodex in McCune-Albright Syndrome

Plain-language summary

This study evaluates the drug Fulvestrant (Faslodex) in girls with McCune-Albright Syndrome (MAS) and associated precocious (early) puberty. It included girls aged 10 or younger diagnosed with MAS. It was a Phase 2 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

AstraZeneca

Intervention

Fulvestrant

Start date

1/31/2006

Estimated completion

7/20/2023

Countries

United States, France, Germany, Italy, Russia, United Kingdom

Related genes

Locations

• Birmingham, United States
• Miami, United States
• Lexington, United States
• Baton Rouge, United States
• The Bronx, United States
• Philadelphia, United States
• Salt Lake City, United States
• Bordeaux, France
• Bron, France
• Paris, France
• Erlangen, Germany
• Osnabrück, Germany
• Torino, Italy
• Moscow, Russia
• Liverpool, United Kingdom
• London, United Kingdom

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Females less than or equal to 10 years of age (prior to 11th birthday)
* Diagnosis of MAS
* PPP associated with MAS

Exclusion Criteria:

* Received any prior treatment for PPP associated with MAS with fulvestrant
* Abnormal platelet count or liver function tests
* Bleeding disorders
* Long term anticoagulation therapy
* Known hypersensitivity to any component of the study drug