N/A N=15 Radiofrequency Ablation of Adenomyosis
Adenomyosis
Primary: Post-operative Evidence of Adenomyoma Tissue Ablation Effect by Area (n) as Assessed by Pathological Analysis — 9; 8; 7; 6 treated areas
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=42 Trial of Mifepristone for Fibroids
Leiomyoma
Primary: Uterine Volume — 719; 449 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…
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=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=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 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=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
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
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
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
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
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=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=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=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 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=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 4 N=40 Effectiveness of IV Acetaminophen and IV Ibuprofen in Reducing Post Procedural Pain in the UFE Procedure
Symptomatic Uterine Fibroids and Adenomyosis
Primary: Evaluation of Maximum Pain Intensity Change Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen — 6.48; 7.27; 6.16; 5.30 units on a scale
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=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
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
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…
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=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 3 N=378 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 (Replicate Study)
Uterine Fibroids · Heavy Menstrual Bleeding
Primary: Percentage of Participants Meeting the Criteria for Responder — 10.5; 76.9; 76.5 percentage of participants — p=< 0.001
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
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
Phase 4 N=1 Ulipristal for Endometriosis-related Pelvic Pain
Endometriosis
Primary: Pelvic Pain — 3.5; 0.2; 3.9 units on a scale — p=<0.05
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