Per-Protocol | Full Analysis set | |||||||
---|---|---|---|---|---|---|---|---|
Baseline | 3 Months | % Reduction from baseline | P valuea | Baseline | 3 Months | % Reduction from baseline | P valuea | |
Number of MRI-evaluable fibroids | 89 | 88 | 89 | 89 | ||||
Number of subjects | 49 | 48 | 49 | 49 | ||||
Perfused fibroid volume (cc) | 18.3 ± 20.6 9.5 (0.3–77.0) | 5.5 ± 9.2 1.6 (0.0–45.7) | 68.8 ± 27.8 % 77.1 % (−33.3–100 %) | <0.0001 | 18.3 ± 20.6 9.5 (0.3–77.0) | 5.8 ± 9.6 1.6 (0.0–45.7) | 68.1 ± 28.6 % 76.9 % (−33.3–100 %) | <0.0001 |
Total fibroid volume (cc) | 18.8 ± 21.4 9.5 (0.3–77.0) | 7.7 ± 11.8 1.9 (0.0–56.3) | 55.3 ± 37.2 % 63.1 % (−85.7–100 %) | <0.0001 | 18.8 ± 21.4 9.5 (0.3–77.0) | 8.0 ± 12.0 1.9 (0.0–56.3) | 54.7 ± 37.4 % 62.5 % (−85.7–100 %) | <0.0001 |