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)
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Change in Frequency of Annualized Days of Vaginal Bleeding on Treatment Compared to Baseline
Timeframe: Baseline (6 month pre-treatment observation period) through Month 12 treatment period
Percentage of Participants With Baseline Vaginal Bleeding Who Experienced ≥ 50% Reduction in the Number of Vaginal Bleeding Days on Treatment Compared to Baseline
Timeframe: Baseline (6 month pre-treatment observation period) through Month 12 treatment period
Percentage of Participants With Baseline Vaginal Bleeding Who Experienced Cessation of Vaginal Bleeding Over a 6-month Treatment Period
Timeframe: Baseline (6-month pre-treatment observation period) through Month 12 treatment period
Percentage of Participants With Baseline Vaginal Bleeding Who Experienced Cessation of Vaginal Bleeding Over the Whole 12-month Treatment Period
Timeframe: Baseline (6 month pre-treatment observation period) through Month 12 treatment period
Change in Rate of Bone Age (BA) Advancement Over First 6-month Treatment Period Compared to Baseline
Timeframe: Baseline (6-month pre-treatment observation period) through Month 6 of treatment period
Change in Rate of BA Advancement Over Second 6-month Treatment Period Compared to Baseline
Timeframe: Baseline (6-month pre-treatment observation period) through second Month 6 of treatment period
Change in Rate of BA Advancement Over the Whole 12-month Treatment Period Compared to Baseline
Timeframe: Baseline (6-month pre-treatment observation period) through Month 12 of treatment period
Change in Growth Velocity (Annualized Growth Velocity in cm/Year) Over First 6-month Treatment Period Compared to Baseline
Timeframe: Baseline (6 month pre-treatment observation period) through first 6-month of treatment period
Change in Growth Velocity (Annualized Growth Velocity in cm/Year) Over Second 6-month Treatment Period Compared to Baseline
Timeframe: Baseline (6 month pre-treatment observation period) through second 6-month treatment period (ie, through 12-month treatment period)
Change in Growth Velocity (Annualized Growth Velocity in cm/Year) Over Whole 12-month Treatment Period Compared to Baseline
Timeframe: Baseline (6 month pre-treatment observation period) through Month 12 of treatment period
Change in Growth Velocity (Z-score) Over the First 6-month Treatment Period Compared to Baseline
Timeframe: Baseline (6 month pre-treatment observation period) through first 6-month treatment period
Change in Growth Velocity (Z-score) Over the Second 6-month Treatment Period Compared to Baseline
Timeframe: Baseline (6 month pre-treatment observation period) through second 6-month treatment period
Change in Growth Velocity (Z-score) Over the Whole 12-month Treatment Period Compared to Baseline
Timeframe: Baseline (6 month pre-treatment observation period) through Month 12 of treatment period
Change in Uterine Volume From Baseline to Month 6 as Assessed by Ultrasound
Timeframe: Baseline (pre-treatment baseline visit) and Month 6 of treatment period
Change in Uterine Volume From Month 6 to Month 12/Final Visit as Assessed by Ultrasound
Timeframe: At Month 6 and Month 12/final visit treatment period
Change in Uterine Volume From Baseline to Month 12/Final Visit as Assessed by Ultrasound
Timeframe: Baseline (pre-treatment screening visit) and Month 12 treatment period
Change in Mean Ovarian Volume From Baseline to Month 6 as Assessed by Ultrasound
Timeframe: Baseline (pre-treatment screening visit) and Month 6 of treatment period
Change Mean in Ovarian Volume From Month 6 to Month 12/Final Visit as Assessed by Ultrasound
Timeframe: At Month 6 and Month 12/final visit treatment period
Change in Mean Ovarian Volume From Baseline to Month 12/Final Visit as Assessed by Ultrasound
Timeframe: Baseline (pre-treatment baseline visit) and Month 12/final visit treatment period
Mean Clearance of Fulvestrant
Timeframe: Post-dose: Weeks 1, 2, 3, and pre-dose: Week 4 of Month 1 for first 6 participants, then pre-dose steady state samples on 2 occasions between Months 6 and 12 with at least 1 month in between wherein first sample drawn at least 30 days following sixth dose
Mean Volume of Distribution (V1/F) of Fulvestrant
Timeframe: Post-dose: Weeks 1, 2, 3, and pre-dose: Week 4 of Month 1 for first 6 participants, then pre-dose steady state samples on 2 occasions between Months 6 and 12 with at least 1 month in between wherein first sample drawn at least 30 days following sixth dose
Mean Volume of Distribution (V2/F) of Fulvestrant
Timeframe: Post-dose: Weeks 1, 2, 3, and pre-dose: Week 4 of Month 1 for first 6 participants, then pre-dose steady state samples on 2 occasions between Months 6 and 12 with at least 1 month in between wherein first sample drawn at least 30 days following sixth dose
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Timeframe: Day 1 through 68.7 weeks (maximum observed duration)
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs
Timeframe: Day 1 through 68.7 weeks (maximum observed duration)
Number of Participants With Compliance to Study Treatment
Timeframe: Day 1 through Month 12 of treatment period
Number of Participants With Withdrawals From Study Treatment Due to TEAE
Timeframe: Day 1 through 68.7 weeks (maximum observed duration)
Hormone Assay: Serum Oestradiol Level
Timeframe: Month 12 (final visit) of treatment period
Hormone Assay: Serum Luteinizing Hormone (LH) Level
Timeframe: Month 12 (final visit) of treatment period
Hormone Assay: Serum Follicle-stimulating Hormone (FSH) Level
Timeframe: Month 12 (final visit) of treatment period
Hormone Assay: Serum Testosterone Level
Timeframe: Month 12 (final visit) of treatment period