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=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 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 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 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 3 N=231 Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding
Metrorrhagia
Primary: Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms — 0.295; 0.012 Proportion of participants — p=< 0.0001
Phase 3 N=190 Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding
Metrorrhagia
Primary: Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms — 0.292; 0.029 Proportion of participants — p=< 0.0001
Phase 3 N=65 Intervention to End Recurrent Unscheduled Bleeding Trial
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
Phase 4 N=18 Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids
Heavy Menstrual Bleeding · Menorrhagia · Uterine Fibroids
Primary: Change in Self-Reported Menorrhagia Scores — 59.1; 25.4 score on a scale — p=0.11
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=157 A Study of the Efficacy and Safety of a 3-month Treatment Course of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas
Leiomyoma · Uterine Hemorrhage
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
Phase 3 N=432 A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas
Leiomyoma · Uterine Hemorrhage
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
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 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 4 N=284 Uterotonic Prophylaxis Trial
Hemorrhage
Primary: Number of Participants With Excessive Bleeding as Determined by the Composite Outcome Criteria — 78; 75 Participants — p=0.5
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 2 N=44 Superior Hypogastric Nerve Block for Pain Control Post-uterine Fibroid Embolization
Leiomyoma
Primary: mg Equivalent Morphine Used Until Discharge From Recovery Room to Control Pain Level Below 4/10 (VAS) — 11; 5.1 mg
N/A N=79 Tracking IUD Bleeding Experiences: An Evaluation of Bleeding Profiles in New Intrauterine Device Users
Intrauterine Devices, Copper · Metrorrhagia · Menstruation
Primary: Evaluate Changes in Bleeding Duration Among Women Initiating the Copper T380 IUD During the 90 Days Prior to Initiation Compared to Two 90 Periods After IUD Insertion…
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 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 2 N=11 Pilot Study of MRI-Guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids
Uterine Fibroids · Uterine Leiomyomata
Primary: Treatment-related Adverse Events (AE) Per Subject Resulting From HIFU Treatment of the Uterine Fibroids — 1.3 treatment-related AE/patient
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
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
N/A N=200 Uterine Cooling During Cesarean Delivery to Reduce Blood Loss and Incidence of Postpartum Hemorrhage
Postpartum Hemorrhage · Uterine Atony
Primary: Blood Loss — 616; 418; 141; 106 cc
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=37 Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS)
Menorrhagia · Metrorrhagia · Medicated Intrauterine Devices
Primary: Number of Bleeding and Spotting Days — 16.8; 12.0 days
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=388 LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Heavy Menstrual Bleeding · Uterine Fibroid
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 — 73.4…
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 3 N=382 LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Heavy Menstrual Bleeding · Uterine Fibroid
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…