N/A N=104 Quality of Life in Premenopausal Women With Heavy Menstrual Bleeding
Heavy Menstrual Bleeding
Primary: Hot Flush Frequency Total Score (HFRS) Change — 9.3; 8.8; 12.7 score on a scale
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=196 Efficacy and Safety Study of XP12B in Women With Menorrhagia
Menorrhagia · Heavy Menstrual Bleeding
Primary: Mean Reduction From Baseline in Menstrual Blood Loss (MBL) — 66; 18 mL
Phase 3 N=165 Study in Women With Idiopathic Menorrhagia to Determine the Reduction in Menstrual Blood Loss (MBL) After Treatment With the Levonorgestrel-releasing Intrauterine System (IUS)
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
Phase 3 N=304 Efficacy and Safety of XP12B in Women With Menorrhagia
Menorrhagia · Heavy Menstrual Bleeding
Primary: Mean Reduction From Baseline in Menstrual Blood Loss (MBL) — 65; 44; 7 mL
Phase 3 N=784 Safety Study of XP12B in Women With Menorrhagia
Menorrhagia · Heavy Menstrual Bleeding
Primary: Number of Subjects With at Least One Adverse Event During the Study — 678 participants
Phase 3 N=105 Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual Bleeding
Menorrhagia
Primary: Number of Participants With Successful Treatment of Heavy Menstrual Bleeding — 81; 83 Participants
Phase 3 N=19 RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding
Venous Thromboembolism · Menstruation
Primary: PBAC Scores — 292; 146 score on a scale
Phase 4 N=48 DMPA & High Dose Oral Progestin (MPA) Tablets in Outpatient Treatment of Acute Excessive Vaginal Bleeding
Dysfunctional Uterine Bleeding
Primary: Cessation of Bleeding Within 5 Days — 48 participants
Phase 4 N=67 Medical Therapy Versus Radiofrequency Endometrial Ablation in the Initial Treatment of Menorrhagia
Menorrhagia
Primary: Menstrual Blood Loss (MBL) as Measured by Pictorial Blood Loss Assessment Chart (PBLAC). — 15; 0 units on a scale — p=0.003
N/A N=21 A Two-Phase Clinical Study of the Minerva AURORA Ablation System
Menorrhagia Due to Benign Causes
Primary: Reduction in Menstrual Blood Loss to Normal Levels at 12-months — 20 participants
N/A N=242 A CLinical Study to Evaluate the Safety And Effectiveness of the CeRene DevIce to Treat HeavY Menstrual Bleeding
Menorrhagia
Primary: Primary Safety Endpoint: Number of Serious Adverse Events and Serious Device-related Adverse Events — 7; 0 Reports of events
Phase 2 N=7 IL-11 in Women With Von Willebrand Disease and Refractory Menorrhagia
Von Willebrand Disease
Primary: >50% Reduction in PBAC (Pictorial Blood Assessment Chart) at 6 Months — 71 percentage of participants
Phase 3 N=288 A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding
Menorrhagia
Primary: Participants With Treatment-Emergent Adverse Events (AEs) — 218; 1; 3; 60 participants
N/A N=17 Tranexamic Acid (TA) vs Combined Oral Contraceptive (COCP) Pilot Study
Menorrhagia
Primary: To Assess the Efficacy of Oral TA and COCP in Adolescents With Menorrhagia. — 536.4; 430.6; 15.6; 16.75 Scores on a scale — p=0.01
Phase 4 N=32 Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding
Heavy Menstrual Bleeding
Primary: Change From Baseline Menses for Participant Perceived Blood Loss — 3; 1.9 score on a scale
Phase 2 N=567 Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
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…
Phase 4 N=106 Evaluation of Modified Treatment Regimens for Treatment of Heavy Menstrual Bleeding Using the HerOption® System
Menorrhagia
Primary: Success (Reduction in Menstruation to Normal Levels) — 59 Participants — p=.271
Phase 3 N=236 Hysterectomy and Levonorgestrel Releasing Intrauterine System (LNG-IUS) in the Treatment of Menorrhagia
Menorrhagia
Primary: HRQoL (Health Related Quality of Life) — 0.08; 0.10 points on a scale
Phase 4 N=18 Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy
Myomectomy; Surgical Blood Loss
Primary: Surgical Blood Loss — 761; 691 ml
Phase 3 N=433 An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
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
Phase 3 N=477 Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding
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
Phase 3 N=229 Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
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…
Phase 3 N=2,018 Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients
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
Phase 3 N=413 Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
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
Phase 2 N=271 Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids
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
Phase 3 N=478 Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Heavy Menstrual Bleeding · Uterine Fibroids
Primary: Number of Participants With Adverse Events (AEs) — 203; 83; 124; 59 Participants
N/A N=1,014 Registry Study of Genesys HTA for Treatment of Menorrhagia
Menorrhagia
Primary: Burn Rate — 4 participants
Phase 3 N=241 PGL4001 Versus Placebo in Uterine Myomas
Uterine Myomas
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…
Phase 4 N=82 A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
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…
Phase 3 N=301 PGL4001 Versus GnRH-agonist in Uterine Myomas
Uterine Myomas
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…