Clinical Trial Search

Primary: Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses — 48.7; 60.5 percentage of subjects

Primary: Changes in Fibroid-related Symptoms After Treatment With Letrozole — -10.42; 1.43 units on a scale — p=0.24

Primary: Number of Participants With Serious Adverse Events — 0; 0 Participants

Primary: Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 — 2; 0 participants

Primary: Progression-free Survival (PFS) > 6 Months — 0.0 percentage of participants

Primary: Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 1 — 0.0; 42.0; 54.8 percentage of participants

Primary: Number of Adverse Events — 1 Participants

Primary: Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment — 1.8; 47.2; 58.3 percentage of participants

Primary: Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment…

Primary: Progression Free Survival Rate at 12 Weeks — 46 percentage of participants

Primary: Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit…

Primary: Change in Worst Lesional Pain in the Past Week Based on Brief Pain Inventory — -2.50; -1.26 units on a scale

Primary: Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS — 78 percentage of participants — p=0.15

Primary: Uterine Volume — 719; 449 mL

Primary: Shrinkage of Fibroids - Size of Fibroids — -0.27; -0.18; 0.07 logcm3 — p=0.43

Primary: Adverse Events/Subject Resulting From HIFU Treatment of the Uterine Fibroids — 2.6 Adverse Event/subject

Primary: Percent Reduction in Target Pathology Volume — 96.9; 99.9 percentage of fibriods/polyps

Primary: Percentage of Subjects With Amenorrhea, Defined as no Scheduled or Unscheduled Bleeding/Spotting After the End of the Initial Bleeding Episode Until End of Treatment…

Primary: Assessment of Menstrual Blood Flow (MBF) at 12 Months Post Procedure — 40.2; 48.8; 59.1; 67.7 Percentage of participants

Primary: Evaluation of All Adverse Events Encountered — 0; 0.95 Adverse Device Effects / patient

Primary: Percentage of Subjects With ≥ 50% Reduction in Menstrual Blood Loss as Assessed by Pictorial Blood Loss Assessment Chart (PBAC) — 64.8 percentage of participants

Primary: Number and Type of Adverse Events — 15 Adverse Events

Primary: Change in Self-Reported Menorrhagia Scores — 59.1; 25.4 score on a scale — p=0.11

Primary: Tumor Response — 0 percentage of participants

Primary: Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month…

Primary: Treatment-related Adverse Events (AE) Per Subject Resulting From HIFU Treatment of the Uterine Fibroids — 1.3 treatment-related AE/patient

Primary: Percentage of Tissue Removed — 97.5 Percentage of tissue removed

Primary: Percentage Of Participants Who Achieved A Menstrual Blood Loss (MBL) Volume Of < 80 mL And A ≥ 50% Reduction From Baseline MBL Volume With Relugolix Plus E2/NETA — 71.2…

Primary: Safety (Adverse Events) — 0 device related adverse event

Primary: Mean Change From Baseline to the Last 28 Days of Treatment in Menstrual Blood Loss (MBL) — 213.70; 269.36; 321.73; 335.11 mL — p=< 0.001