Phase 4 N=12 Pilot of Letrozole for Uterine Myomas
Leiomyoma · Uterine Fibroids
Primary: Changes in Fibroid-related Symptoms After Treatment With Letrozole — -10.42; 1.43 units on a scale — p=0.24
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=33 Therapeutic Magnetic Resonance Imaging (MRI)-Guided High Intensity Focused Ultrasound (HIFU) Ablation of Uterine Fibroids
Uterine Fibroids
Primary: Adverse Events/Subject Resulting From HIFU Treatment of the Uterine Fibroids — 2.6 Adverse Event/subject
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=451 PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
Uterine Fibroids
Primary: Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses — 48.7; 60.5 percentage of subjects
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
N/A N=3 Safety and Effectiveness of OCL 503 in the Treatment of Women With Leiomyomata
Leiomyomata
Primary: Number of Participants With Serious Adverse Events — 0; 0 Participants
N/A N=9 Magnetic Resonance (MR) Guided Focused Ultrasound Surgery of Uterine Fibroids
Leiomyoma
Primary: Number and Type of Adverse Events — 15 Adverse Events
Phase 2 N=42 Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914
Leiomyoma
Primary: Shrinkage of Fibroids - Size of Fibroids — -0.27; -0.18; 0.07 logcm3 — p=0.43
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
N/A N=3 Hysteroscopic Cryomyolysis for the Treatment of Submucosal Leiomyomata
Uterine Fibroids · Leiomyoma · Menorrhagia
Primary: Number of Adverse Events — 1 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…
N/A N=73 Clinical Study of the Mirabilis High-Intensity Focused Ultrasound System for Non-Invasive Treatment of Uterine Fibroids
Uterine Fibroids (Leiomyomas)
Primary: Evaluation of All Adverse Events Encountered — 0; 0.95 Adverse Device Effects / patient
Phase 2 N=309 Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap
Leiomyoma
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…
Phase 3 N=42 Trial of Mifepristone for Fibroids
Leiomyoma
Primary: Uterine Volume — 719; 449 mL
N/A N=137 Laparoscopic Radiofrequency Ablation (RFA) of Symptomatic Uterine Fibroids
Uterine Fibroids · Uterine Myomas
Primary: Assessment of Menstrual Blood Flow (MBF) at 12 Months Post Procedure — 40.2; 48.8; 59.1; 67.7 Percentage of participants
N/A N=147 Sonography Guided Transcervical Ablation of Uterine Fibroids
Menorrhagia
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
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
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…
N/A N=108 ExAblate UF V2 System for the Treatment of Symptomatic Uterine Fibroids
Uterine Fibroids
Primary: Percentage of Participants With Leg Pain or Lower Extremity Neuropathy Persisting or Occuring Greater Than 10 Days Following Treatment — 0 Percentage of participants
Phase 2 N=43 A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
Uterine Fibroids
Primary: Percentage of Participants in Amenorrhea at the End of Treatment Course 1 — 58.33; 70.59; 0.0 percentage of participants — p=0.0008
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 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 2 N=20 Trabectedin in Treating Patients With Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus
Sarcoma
Primary: Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 — 2; 0 participants
Phase 2 N=40 Evaluation of Safety, Pharmacokinetics, and Efficacy of Proellex Administered Vaginally in Women With Uterine Fibroids
Uterine Fibroids
Primary: Change From Baseline in Vaginal Bleeding — -83.5; -36.0; -63.5; -39.5 mL
Phase 2 N=42 Safety and Efficacy of Telapristone Acetate (Proellex®) Administered Vaginally for the Treatment of Uterine Fibroids
Uterine Fibroids
Primary: Percentage of Participants in Amenorrhea at the End of Treatment Course 1 — 0.0; 53.8; 46.7 percentage of participants — p=0.0019
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 3 N=50 MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication
Uterine Leiomyoma · Uterine Fibroids
Primary: Number of Adverse Events — 77; 75 Adverse Events
N/A N=11 Clinical Evaluation of the Interlace Medical Hysteroscopic Morcellator
Abnormal Uterine Bleeding · Infertility
Primary: Percentage of Tissue Removed — 97.5 Percentage of tissue removed
Phase 4 N=60 A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)
Leiomyoma · Uterine Fibroids · Uterine Neoplasms
Primary: Number of Participants With Fibroid Devascularization Measured by Contrast Enhanced Magnetic Resonance Imaging (MRI) — 29; 29 participants
Phase 2 N=26 Letrozole in Women With Advanced Estrogen/Progesterone Receptor Positive Uterine Leiomyosarcoma
Leiomyosarcoma
Primary: Progression Free Survival Rate at 12 Weeks — 46 percentage of participants