Clinical trials: Uterine Fibroids (Leiomyoma)
Menorrhagia, Leiomyoma
Observational Prospective Study on Patients With Symptomatic Uterine Fibroids Treated With VizAblate® Intrauterine-ultrasound Guided RF Ablation
Study is intended to evaluate the one-year safety and clinical status of patients treated for symptomatic uterine fibroids with the VizAblate Intrauterine-ultrasound guided radio frequency (RF) ablation system.
- Conditions
- Menorrhagia, Leiomyoma, Uterine Fibroids, Uterine Fibroma
- Trial name
- NCT01998854
- Testing
- VizAblate System
- Where
- 2 sites in France
- Volunteers
- 4 people
- Sponsor
- Gynesonics
Uterine Fibroids and Heavy Menstrual Bleeding
A Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding
To evaluate the safety and efficacy of vilaprisan in Japanese subjects with uterine fibroids and heavy menstrual bleeding (HMB).
- Trial name
- ASTEROID 8 (NCT03476928)
- Testing
- Vilaprisan (BAY1002670)
- Where
- 25 sites in Japan
- Volunteers
- 153 people
- Sponsor
- Bayer
Symptomatic Uterine Fibroids
Post Market TRUST - U.S.A. Study
This Post Market study is being conducted to compare the direct and indirect cost of three approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of symptomatic uterine fibroids.
- Trial name
- NCT02163525
- Testing
- Global Fibroid Ablation (GFA), Abdominal or Laparoscopic Myomectomy, Uterine Artery Embolization (UAE)
- Where
- 9 sites in United States
- Volunteers
- 114 people
- Sponsor
- Acessa Health, Inc.
Uterine Fibroid, Myoma
OCL 500 Treatment of Women With Symptomatic Uterine Fibroids
This is a prospective, open-label, single-arm, safety and effectiveness study of Occlusin 500 microspheres in women with symptomatic uterine fibroids.
- Conditions
- Uterine Fibroid, Myoma, Leiomyoma
- Trial name
- NCT03427671
- Testing
- Occlusin 500 Microspheres
- Where
- Canada
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- IMBiotechnologies Ltd.
Contraception
Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy
The purpose of this study is to assess the contraceptive efficacy of relugolix combination therapy.
- Trial name
- SERENE (NCT04756037)
- Testing
- Relugolix Combination Therapy
- Where
- 112 sites in United States, Puerto Rico
- Volunteers
- 1,164 people
- Sponsor
- Sumitomo Pharma Switzerland GmbH
Uterine Fibroid
Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry
SAGE is an observational post market registry with the objective of characterizing long term outcomes after treatment of uterine fibroids with the Sonata System in real world clinical practice settings.
- Trial name
- SAGE (NCT03118037)
- Testing
- Sonata System
- Where
- 9 sites in Germany, Switzerland and 1 more
- Volunteers
- 182 people
- Sponsor
- Gynesonics
Pregnancy Related, Pregnancy Complications
MYFEMBREE®: A Retrospective Cohort Study Using an Administrative Healthcare Database to Assess Pregnancy Outcomes in Women Treated With Relugolix Combination Therapy
This is a retrospective cohort study that will be conducted using secondary de-identified electronic healthcare data (EHD) that originally were collected for the purposes of health insurance billing and/or routine patient care…
- Conditions
- Pregnancy Related, Pregnancy Complications, Pregnancy, High Risk
- Trial name
- NCT05739136
- Testing
- Relugolix + Estradiol + Norethindrone Acetate
- Where
- United States
- Volunteers
- 530 people
- Sponsor
- Sumitomo Pharma Switzerland GmbH
Uterine Fibroids
China Clinical Trial for Therapeutic MR-HIFU Ablation of Uterine Fibroids
The purpose of this study is to demonstrate safety and effectiveness of the Philips Sonalleve Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) for treatment of uterine fibroids in a Chinese population.
- Trial name
- NCT01588899
- Testing
- MR-HIFU uterine fibroid treatment
- Where
- 2 sites in China
- Volunteers
- 107 people
- Sponsor
- Philips Healthcare
Myoma of Uterus
Clinical Trial to Evaluate the Efficacy and Safety of DW4902
A Multi-center, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of DW4902 in Patients with Uterine Fibroids.
- Trial name
- NCT07319520
- Testing
- DW4902 160mg, DW4902 240mg, DW4902 320mg
- Where
- South Korea
- Volunteers
- 71 people
- Sponsor
- Daewon Pharmaceutical Co., Ltd.
Uterine Fibroids
A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada
This is a non-interventional, cross-sectional survey study to evaluate the effectiveness of the Additional Risk Minimization Measures for Fibristal among Healthcare Professionals (HCPs).
- Trial name
- NCT04567589
- Where
- United States
- Sponsor
- Allergan
Uterine Fibroid
Safety and Efficacy of Actamax™Adhesion Barrier in Women Undergoing Laparoscopic Abdominopelvic Surgery/Myomectomy
Women undergoing laparoscopic abdominopelvic surgery with a planned, second look laparoscopy within 8-12 (+4) weeks will be enrolled. All subjects must undergo myomectomy with/without treatment of co-existing pathology e.g.
- Trial name
- NCT03450421
- Testing
- Actamax™Adhesion Barrier
- Volunteers
- 152 people
- Sponsor
- Actamax Surgical Materials LLC
Leiomyoma
Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap
The study is performed to assess the efficacy and safety of different doses of BAY1002670 in subjects with uterine fibroids. The dose-response relationship will be evaluated.
- Trial name
- ASTEROID 1 (NCT02131662)
- Testing
- BAY1002670
- Where
- 105 sites in United States, Belgium and 11 more
- Volunteers
- 309 people
- Sponsor
- Bayer
Pregnancy Related, Pregnancy Complications
Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring
The Relugolix Pregnancy Registry is a prospective, observational cohort study designed to evaluate the association between relugolix-containing therapy exposure during pregnancy and subsequent maternal, fetal, and infant…
- Conditions
- Pregnancy Related, Pregnancy Complications, Pregnancy, High Risk
- Trial name
- NCT05739123
- Testing
- Relugolix-Containing Product
- Where
- United States
- Volunteers
- 728 people
- Sponsor
- Sumitomo Pharma Switzerland GmbH
Menorrhagia, Uterine Fibroids
to Evaluate the Efficacy and Safety of KLH-2109 in Patients With Uterine Fibroids and Menorrhagia
The goal of this clinical trial was to determine whether the investigational drug KLH-2109 is effective for treating excessive menstrual bleeding in patients with uterine fibroids.
- Trial name
- NCT07378098
- Where
- South Korea
- Volunteers
- 254 people
- Sponsor
- JW Pharmaceutical
Uterine Fibroids, Polyps
MyoSure Hysteroscopic Tissue Removal System Registry Study
The objective of this study is to demonstrate the safety and effectiveness of community gynecologist initiated treatment of intra-uterine polyps and submucosal fibroids with the MyoSure Hysteroscopic Tissue Removal System in a…
- Trial name
- NCT01369758
- Testing
- MyoSure Tissue Removal System
- Where
- United States
- Volunteers
- 290 people
- Sponsor
- Hologic, Inc.
Heavy Menstrual Bleeding, Uterine Fibroid
LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
The purpose of this study is to determine the benefit of relugolix 40 milligrams (mg) once a day co-administered with estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg compared with placebo for 24 weeks on heavy…
- Trial name
- NCT03103087
- Testing
- Relugolix, Estradiol/norethindrone acetate
- Where
- 127 sites in United States, Belgium and 6 more
- Volunteers
- 382 people
- Sponsor
- Myovant Sciences GmbH
Menorrhagia, Uterine Fibroids
Doppler-Guided Uterine Artery Occlusion (DUAO) Device for Fibroid Related Bleeding
The objective of this study is to evaluate the safety and effectiveness of Doppler guided uterine artery occlusion (D-UAO) for the reduction of fibroid associated bleeding.
- Trial name
- DUAO (NCT00496080)
- Testing
- Doppler-Guided Uterine Artery Occlusion Device (DUAO)
- Where
- 11 sites in United States, Canada and 1 more
- Volunteers
- 87 people
- Sponsor
- Ethicon, Inc.
Uterine Fibroids (MeSH Heading: Leiomyoma)
A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia
Multi-center, randomized, double-blind, parallel-group study to confirm non-inferiority of KLH-2109 to Leuprorelin acetate in uterine fibroids patient with menorrhagia
- Trial name
- NCT05440383
- Testing
- KLH-2109, Leuprorelin
- Where
- Japan
- Volunteers
- 287 people
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
Leiomyomas
Somatic Stem Cells in Leiomyomas?
The purpose of this study is to identify and characterize the Somatic Stem Cell (SSC) responsible for the formation and growth of leiomyomas using the Side Population method.
- Trial name
- NCT01592903
- Testing
- Laparoscopic myomectomy. Following analysis and proliferation of cells isolated from removed human leiomyoma.
- Where
- Spain
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Igenomix
Uterine Leiomyomas
Therapeutic MRI-HIFU Ablation of Uterine Fibroids in a 3T MRI Scanner
This study is to collect supplementary safety and technical effectiveness data of Philips MRI guided High Intensity Focused Ultrasound (HIFU) in ablating uterine tissue associated with symptomatic fibroids in a 3T MRI scanner.
- Trial name
- NCT01064960
- Testing
- Philips MR-guided HIFU system
- Where
- Norway
- Volunteers
- 7 people
- Sponsor
- Philips Healthcare