Femme Homme
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Extrait
The primary objective of the trial is composed of two components: A safety and efficacy component and a pharmacokinetics (PK) component. All patients fulfilling the eligibility criteria will participate in both components of the trial. The safety of study treatment will be evaluated by assessments of adverse events, withdrawals, laboratory data, ovarian volume as assessed by ultrasound, including the number of ovarian cysts and size of the largest cyst, and uterine volume. The efficacy of study treatment will be based on change in frequency of vaginal bleeding days, rate of increase in bone age, and growth rate. The second component will assess the pharmacokinetics of fulvestrant in girls with progressive precocious puberty (PPP) associated with McCune-Albright syndrome (MAS).
Critère d'inclusion
- Progressive Precocious Puberty Associated with McCune Albright Syndrome