Trials / Completed
CompletedNCT00278915
Faslodex in McCune-Albright Syndrome
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- Female
- Age
- 1 Year – 10 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fulvestrant | Participants will receive intramuscular injection of fulvestrant as stated in arm description. |
Timeline
- Start date
- 2006-01-31
- Primary completion
- 2009-12-08
- Completion
- 2023-07-20
- First posted
- 2006-01-19
- Last updated
- 2024-03-05
- Results posted
- 2011-07-19
Locations
16 sites across 6 countries: United States, France, Germany, Italy, Russia, United Kingdom
Source: ClinicalTrials.gov record NCT00278915. Inclusion in this directory is not an endorsement.