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Leiomyoma

1 published article · Updated continuously

Clinical Trial Landscape

Clinical Trials for Leiomyoma

14 trials tracked for Leiomyoma: 7 in phase 3 or 4 and 3 with published results. The most-cited published study has 1566 citations.

14Trials tracked
7Phase 3 & 4
0Recruiting
3With published results
Phase distribution
Phase 4 3 Phase 3 4 Phase 2 3 Other / NA 4
  1. Phase 4 Combined Vaginal Misoprostol and Perivascular Vasopressin Completed · 1,566 cited
  2. Phase 3 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 Completed · 54 cited
  3. Phase 3 A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas Completed · 40 cited
  4. Phase 4 Pilot of Letrozole for Uterine Myomas Completed
  5. Phase 4 A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE) Completed
  6. Phase 3 Dexamethasone for Post Uterine Artery Embolization Pain Completed
Show 8 more trials
  1. Phase 3 Trial of Mifepristone for Fibroids Completed
  2. Phase 2 Superior Hypogastric Nerve Block for Pain Control Post-uterine Fibroid Embolization Completed
  3. Phase 2 Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap Completed
  4. Phase 2 Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914 Completed
  5. N/A Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy Completed
  6. N/A Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy Completed
  7. N/A Hysteroscopic Cryomyolysis for the Treatment of Submucosal Leiomyomata Completed
  8. N/A Magnetic Resonance (MR) Guided Focused Ultrasound Surgery of Uterine Fibroids Completed

Showing the 14 most-cited and recently-updated of 14 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found For clinicians

Leiomyoma: what the trials found

Ulipristal acetate (UPA) is effective for controlling bleeding in women with uterine fibroids. In two phase 3 trials, UPA 5 mg and 10 mg led to absence of bleeding during the last 35 consecutive days of treatment in 42.0% and 54.8% of participants, respectively, compared to 0% with placebo in treatment course 1 5. Similar results were observed in another phase 3 trial, with 47.2% and 58.3% achieving amenorrhea versus 1.8% for placebo 4. UPA also improved quality of life, as measured by the UFS-QOL revised activities subscale, with changes from baseline ranging from 18.26 to 61.04 across doses and studies 4.

Uterine fibroid embolization (UFE) improved symptom-specific quality of life, with UFS-QOL scores of 18.0 and 22.9 reported in a phase 4 trial 3. Standard care was evaluated in a phase 4 trial 1. Letrozole did not significantly change fibroid-related symptoms (p=0.24) in a small phase 4 study 2. Dexamethasone was associated with pain scores ranging from 0.8 to 6.3 on the VAS in a phase 3 trial 6. Mifepristone was studied in a phase 3 trial 7.

Recent results — preliminary, needs further review

  • BAY1002670, a phase 2 investigational agent, showed amenorrhea rates of 54.1-60% across doses, with a reduction in menstrual blood loss of up to -203.43 mL per 28 days 9.
  • Ulipristal acetate 20 mg (phase 2) did not significantly reduce fibroid size (p=0.43) but improved quality of life scores (p<0.05) 10.
  • EcoSac 400 ECO-T 11, ExAblate 2000 12, cryoablation (return to normal activity in 6 days) 13, and SprayShield™ (mean severity score 0.8-1.63) 14 are under investigation in phase N/A trials.
  • 0.75% ropivacaine was studied in a phase 2 trial 8.

For the clinician treating this condition

  • Ulipristal acetate is effective for achieving amenorrhea and improving quality of life in women with symptomatic fibroids 45.
  • Uterine fibroid embolization improves symptom-specific quality of life 3.
  • Letrozole did not show significant symptom improvement in a small trial 2.

AI synthesis of 14 cited trials, updated Jun 29, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.