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 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
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
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 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=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
N/A N=24 Coagulation Factor Changes Associated With Postpartum Hysterectomies
Obstetric Labor Complications · Hemorrhage · Complications; Cesarean Section
Primary: Fibrinogen Level at 2 Hours After Delivery — 186; 418 mg/dL — p=<0.05
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=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=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=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 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=18 Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy
Myomectomy; Surgical Blood Loss
Primary: Surgical Blood Loss — 761; 691 ml
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=19 RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding
Venous Thromboembolism · Menstruation
Primary: PBAC Scores — 292; 146 score on a scale
N/A N=38 Mirena and Estrogen for Control of Perimenopause Symptoms and Ovulation Suppression
Menopausal and Other Perimenopausal Disorders
Primary: Hot Flashes — 10.3; 7.944 scores on a scale
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 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=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
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
Early Phase 1 N=6 Investigation of Female Reproductive Hormone Dynamics During Adolescence
Menstruation Disturbances
Primary: Ovulation in Cycle 2 — 3; 2 Participants
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…
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
N/A N=491 Evaluation of Postoperative Blood Pressure Changes After Benign Gynecologic Surgery
Urogynecology
Primary: Percentage of Participants Who Underwent Gynecologic Surgery — 42; 32; 26 percentage of participants
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=42 Trial of Mifepristone for Fibroids
Leiomyoma
Primary: Uterine Volume — 719; 449 mL
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=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