At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
Fulvestrantdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Fulvestrant for Puberty, Precocious and McCune-Albright Syndrome. Completed, enrolled 30 participants across 16 sites in 6 countries.
Detailed 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)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPuberty, Precocious, McCune-Albright Syndrome
CountriesFrance, Germany, Italy, Russia, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 2006
Enrollment StartJan 2006
Primary CompletionDec 2009
Study CompletionJul 2023
TodayJul 2026
First PostedJan 19, 2006
Enrollment StartJan 31, 2006
Primary CompletionDec 8, 2009
Study CompletionJul 20, 2023
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 20.5 years ago
Interventions
Fulvestrantdrug
Participants will receive intramuscular injection of fulvestrant as stated in arm description.