Clinical trials: Fibromyoma
Uterine Fibroids
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
The study was performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care
- Trial name
- ASTEROID 6 (NCT03194646)
- Testing
- Vilaprisan (BAY1002670), Standard of care
- Where
- 219 sites in United States, China and 11 more
- Volunteers
- 1,272 people
- Sponsor
- Bayer
Uterine Fibroids, Uterine Artery Embolization
Preemptive Analgesia Following Uterine Artery Embolization
Uterine leiomyomata, also known as fibroids, are an extremely common benign lesion being present in 30-50% of all women. Traditional surgical treatment of symptomatic fibroids has been hysterectomy in post child bearing woman.
- Trial name
- NCT01555073
- Testing
- pregabalin/celecoxib
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Northwestern University
Uterine Fibroids, Uterine Leiomyomata
Pilot Study of MRI-Guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids
Uterine fibroids (leiomyomas) are a common cause of heavy uterine bleeding and pain in reproductive aged women and are the most common cause of hysterectomy in the United States.
- Trial name
- NCT00837161
- Testing
- Philips MR guided HIFU system
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- Philips Healthcare
Leiomyoma
Magnetic Resonance (MR) Guided Focused Ultrasound Surgery of Uterine Fibroids
The goal of this study is to develop additional long term data to evaluate the safety and effectiveness of this treatment. Indications for use for this system is: 'The ExAblate is intended to ablate uterine fibroid tissue in pre…
- Trial name
- NCT00131365
- Testing
- ExAblate 2000
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- InSightec
Uterine Fibroids
A Phase 3 Study to Evaluate the Efficacy and Safety of Relugolix (TAK-385) 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids
The purpose of this study is to evaluate the efficacy of Relugolix (TAK-385) 40 mg administered orally once daily for 12 weeks, compared with leuprorelin injection (once every 4 weeks, 1.88 mg or 3.75 mg subcutaneously [SC]/time)…
- Trial name
- NCT02655237
- Testing
- Relugolix, Leuprorelin
- Where
- 25 sites in Japan
- Volunteers
- 281 people
- Sponsor
- Takeda
Uterine Fibroids, Uterine Myomas
Laparoscopic Radiofrequency Ablation (RFA) of Symptomatic Uterine Fibroids
The purpose of this study is to demonstrate the safety and effectiveness of radiofrequency ablation (RFA) using the Halt System for the treatment of patients with symptomatic uterine fibroids.
- Trial name
- Halt (NCT00874029)
- Testing
- Halt Procedure
- Where
- 11 sites in United States, Guatemala and 1 more
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- Acessa Health, Inc.
Uterine Fibroids
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
Phase III, multicentre, randomized, double-blind, parallel group, long-term study investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment of uterine myoma.
- Trial name
- PEARLIV (NCT01629563)
- Testing
- PGL4001 5 mg, PGL4001 10 mg
- Where
- 49 sites in Belgium, Czechia and 9 more
- Volunteers
- 451 people
- Sponsor
- PregLem SA
Uterine Fibroids
Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids
Safety and efficacy study of 25 and 50 mg doses of Proellex
- Trial name
- NCT01069120
- Testing
- Proellex
- Where
- 4 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Uterine Fibroids
An Extension Study Evaluating Safety and Efficacy of Proellex® In Women Who Have Previously Completed ZPU 003 Ext
An open label, extension study for subjects completing the ZPU-003 Ext 1 study.
- Trial name
- NCT00958893
- Testing
- 25 mg Proellex
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Repros Therapeutics Inc.
Uterine Fibroids (Leiomyomas)
Clinical Study of the Mirabilis High-Intensity Focused Ultrasound System for Non-Invasive Treatment of Uterine Fibroids
The Mirabilis High-Intensity Focused Ultrasound (HIFU) Treatment System delivers therapeutic focused ultrasound energy to the uterus under integrated ultrasound imaging guidance to offer non-invasive treatment for uterine…
- Trial name
- NCT01946178
- Testing
- Mirabilis High-Intensity Focused Ultrasound Treatment System
- Where
- 2 sites in Mexico
- Volunteers
- 73 people
- Sponsor
- Mirabilis Medica, Inc.
Symptomatic Uterine Fibroids and Adenomyosis
Effectiveness of IV Acetaminophen and IV Ibuprofen in Reducing Post Procedural Pain in the UFE Procedure
The uterine fibroid embolization (UFE) procedure is a treatment option for abnormal heavy menstrual bleeding and/or bulk symptoms associated with uterine fibroids and adenomyosis.
- Trial name
- NCT02227316
- Testing
- IV Ibuprofen, IV Acetaminophen
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- University of California, Los Angeles
Leiomyoma, Uterine Hemorrhage
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
This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids
- Trial name
- NCT02147197
- Testing
- Ulipristal acetate (UPA)
- Where
- 28 sites in United States
- Volunteers
- 157 people
- Sponsor
- Allergan
Cancer Debulking, Enlarged Uterus
Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy
To determine if opioid consumption postoperatively among patients undergoing non-emergent laparotomy by the gynecologic oncology service who receive intrathecal morphine with intraoperative lidocaine (IML) infusion are lower than…
- Conditions
- Cancer Debulking, Enlarged Uterus, Fibroid Uterus, Adnexal Mass
- Trial name
- NCT05017246
- Testing
- Bupivacaine, Morphine, Lidocaine
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Washington University School of Medicine
Fibroid, Myoma
Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy
This study is planned as a prospective, randomised, parallel, controlled, multi-centre, open label, comparative evaluation of SprayShield™ Adhesion Barrier plus good surgical technique, versus good surgical technique alone, with…
- Conditions
- Fibroid, Myoma, Leiomyoma
- Trial name
- NCT00891657
- Testing
- SprayShield™
- Where
- Germany
- Volunteers
- 15 people
- Sponsor
- Integra LifeSciences Corporation
Fibroids
Misoprostol for Reduction of Blood Loss During Fibroid Surgery
The aim of this research work is to assess the impact of a single preoperative dose of buccal misoprostol in reducing blood loss during abdominal fibroid surgery.
- Trial name
- NCT02209545
- Testing
- Misoprostol
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Uterine Fibroids
Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids
The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.
- Trial name
- NCT00737282
- Testing
- Proellex 25 mg, Proellex 50 mg
- Where
- 25 sites in United States
- Volunteers
- 175 people
- Sponsor
- Repros Therapeutics Inc.
Fibroids
Uterine Filling Pressure in Hysteroscopy
The aim of the study is to compare the outcomes of patients undergoing hysteroscopy with a MyoSure device with a pressure of 60 mmHg to those using the standard of 80 mmHg.
- Trial name
- NCT04550429
- Testing
- MyoSure Hysteroscopic Morcellator Device
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Northwestern University
Leiomyoma
Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914
This study will evaluate whether the experimental drug ulipristal acetate can shrink uterine fibroids in pre-menopausal women.
- Trial name
- NCT00290251
- Testing
- ulipristal acetate 20 mg, ulipristal acetate 10 mg
- Where
- 2 sites in United States
- Volunteers
- 72 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Uterine Fibroids, Heavy Menstrual Bleeding
An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
This is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate the long-term efficacy and safety of…
- Trial name
- NCT02925494
- Testing
- Estradiol/Norethindrone Acetate, Elagolix
- Where
- 124 sites in United States, Canada and 1 more
- Volunteers
- 433 people
- Sponsor
- AbbVie
Uterine Fibroids, Anemia
Safety and Efficacy of Proellex in Pre-menopausal Anemic Women With Symptomatic Uterine Fibroids
Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment.
- Trial name
- NCT00702702
- Testing
- Proellex 25 mg, Proellex 50 mg
- Where
- 30 sites in United States
- Volunteers
- 56 people
- Sponsor
- Repros Therapeutics Inc.