Faslodex in McCune Albright Syndrome
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Other Indications, Endocrine |
| Therapuetic Areas: | Endocrinology, Other |
| Healthy: | No |
| Age Range: | 1 - 10 |
| Updated: | 2/7/2019 |
| Start Date: | January 31, 2006 |
| End Date: | July 3, 2023 |
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
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
(early puberty) in girls with McCune-Albright syndrome (MAS).
study drug called Faslodex (fulvestrant) in the treatment of progressive precocious puberty
(early puberty) in girls with McCune-Albright syndrome (MAS).
Inclusion Criteria:
- Females less than or equal to 10 years of age (prior to 11th birthday)
- Diagnosis of McCune-Albright syndrome (MAS)
- Progressive precocious puberty (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
We found this trial at
8
sites
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