30 closest matches · ranked by relevance
Heavy Menstrual Bleeding
Primary: Hot Flush Frequency Total Score (HFRS) Change — 9.3; 8.8; 12.7 score on a scale
Dysfunctional Uterine Bleeding
Primary: Cessation of Bleeding Within 5 Days — 48 participants
Menorrhagia
Primary: Number of Participants With Successful Treatment of Heavy Menstrual Bleeding — 81; 83 Participants
Venous Thromboembolism · Menstruation
Primary: PBAC Scores — 292; 146 score on a scale
Menorrhagia
Primary: The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6) — -128.78; -17.7 milliliter (mL) — p=<0.001
Menorrhagia · Heavy Menstrual Bleeding
Primary: Mean Reduction From Baseline in Menstrual Blood Loss (MBL) — 65; 44; 7 mL
Menorrhagia · Heavy Menstrual Bleeding
Primary: Mean Reduction From Baseline in Menstrual Blood Loss (MBL) — 66; 18 mL
Menorrhagia
Primary: Primary Safety Endpoint: Number of Serious Adverse Events and Serious Device-related Adverse Events — 7; 0 Reports of events
Hemorrhage
Primary: Number of Participants With Excessive Bleeding as Determined by the Composite Outcome Criteria — 78; 75 Participants — p=0.5
Menorrhagia
Primary: Menstrual Blood Loss (MBL) as Measured by Pictorial Blood Loss Assessment Chart (PBLAC). — 15; 0 units on a scale — p=0.003
Menorrhagia
Primary: Participants With Treatment-Emergent Adverse Events (AEs) — 218; 1; 3; 60 participants
Menorrhagia · Heavy Menstrual Bleeding
Primary: Number of Subjects With at Least One Adverse Event During the Study — 678 participants
Heavy Uterine Bleeding · Uterine Fibroids
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…
Heavy Menstrual Bleeding · Menorrhagia · Uterine Fibroids
Primary: Change in Self-Reported Menorrhagia Scores — 59.1; 25.4 score on a scale — p=0.11
Menorrhagia Due to Benign Causes
Primary: Reduction in Menstrual Blood Loss to Normal Levels at 12-months — 20 participants
Menorrhagia
Primary: Success (Reduction in Menstruation to Normal Levels) — 59 Participants — p=.271
Anemia
Primary: Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC. — 6; 22 participants
Anemia
Primary: Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL — 187; 139 participants
Heavy Menstrual Bleeding
Primary: Change From Baseline Menses for Participant Perceived Blood Loss — 3; 1.9 score on a scale
Metrorrhagia
Primary: Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms — 0.295; 0.012 Proportion of participants — p=< 0.0001
Metrorrhagia
Primary: Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms — 0.292; 0.029 Proportion of participants — p=< 0.0001
Uterine Fibroids
Primary: Percentage of Participants Who Were Responders With Menstrual Blood Loss (MBL) Volume < 80 mL at Final Month and >= 50% Reduction in MBL Volume From Baseline to the…
Uterine Fibroids · Heavy Menstrual Bleeding
Primary: Percentage of Participants Meeting the Criteria for Responder — 8.7; 84.1; 68.5 percentage of participants — p=< 0.001
Bleeding · Implants · Breakthrough Bleeding
Primary: Total Number of Consecutive Bleeding-free Days in First 30 Days From Day 1 of First Treatment (TX1) — 18.5; 8.7 days
Contraception · Bleeding
Primary: Number of Bleeding/Spotting Days With Use of Ulipristal Acetate as Measured by Daily Bleeding Diaries — 7; 12 days — p=0.002
Myomectomy; Surgical Blood Loss
Primary: Surgical Blood Loss — 761; 691 ml
Heavy Uterine Bleeding · Uterine Fibroids
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
Uterine Leiomyoma · Uterine Fibroids
Primary: Percentage Of Participants Who Maintained MBL Volume Of <80 Milliliters (mL) At Week 76 During The Randomized Treatment Period — 78.43; 15.08 percentage of participants…
Heavy Menstrual Bleeding · Uterine Fibroids
Primary: Number of Participants With Adverse Events (AEs) — 203; 83; 124; 59 Participants
Uterine Fibroids · Heavy Menstrual Bleeding
Primary: Percentage of Participants Meeting the Criteria for Responder — 85.7; 66.7; 89.4; 87.9 percentage of participants