Clinical trials: Fibroid
Uterine Fibroids
Post Market TRUST 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
- TRUST (NCT01563783)
- Testing
- Global Fibroid Ablation (GFA), Abdominal or Laparoscopic Myomectomy, Uterine Artery Embolization (UAE)
- Where
- Canada
- Volunteers
- 84 people
- Sponsor
- Acessa Health, Inc.
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, Heavy Menstrual Bleeding
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)
This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in…
- Trial name
- NCT02691494
- Testing
- Elagolix, Estradiol/Norethindrone Acetate
- Where
- 105 sites in United States, Canada
- Volunteers
- 378 people
- Sponsor
- AbbVie
Uterine Fibroids, Heavy Menstrual Bleeding
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
This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in…
- Trial name
- NCT02654054
- Testing
- Elagolix, Estradiol/Norethindrone Acetate
- Where
- 96 sites in United States, Canada and 1 more
- Volunteers
- 413 people
- Sponsor
- AbbVie
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
Leiomyomas
Efficacy and Safety Study of Ulipristal Acetate in Females With Anemia Associated With Uterine Leiomyoma
The purpose of this study is to determine whether ulipristal acetate is effective in the treatment of females with anemia associated with uterine leiomyomas. The safety of this product will also be evaluated.
- Trial name
- NCT01553123
- Testing
- Ulipristal Acetate, Iron
- Where
- 47 sites in United States
- Sponsor
- Watson Pharmaceuticals
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 (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.
Leiomyoma, Uterine Fibroids
Fibroid Ablation Study - Large Fibroids
The purpose of this study is to establish the effectiveness and confirm the safety of the VizAblate System in the ablation of large (> 5 cm) symptomatic uterine fibroids.
- Conditions
- Leiomyoma, Uterine Fibroids, Menorrhagia
- Trial name
- FAST-L (NCT01539187)
- Testing
- VizAblate System
- Where
- 10 sites in Mexico, Netherlands and 1 more
- Volunteers
- 6 people
- Sponsor
- Gynesonics
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.
Uterine Fibroid
Post-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids
The goal of this Registry Study is to capture clinical pregnancy outcomes and fibroid treatment background data for any subject post-Exablate treatment for their symptomatic fibroids.
- Trial name
- NCT05386615
- Testing
- Body System - Functional
- Where
- 6 sites in United States, China
- Volunteers
- 200 people
- Sponsor
- InSightec
Uterine Fibroids
Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003
ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258) to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study.
- Trial name
- NCT00958334
- Testing
- Proellex®
- Where
- 11 sites in United States
- Volunteers
- 65 people
- Sponsor
- Repros Therapeutics Inc.
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
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.
Uterine Fibroids, Polyps
Comparative Sedation Study of the MyoSure Hysteroscopic Tissue Removal System
The purpose of this study is to develop a recommended local anesthetic protocol and post-treatment pain management regimen, in order to assure patient comfort during office-based treatment with the MyoSure Hysteroscopic Tissue…
- Trial name
- NCT00979342
- Testing
- Hysteroscopic Morcellator
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Hologic, Inc.
Uterine Fibroids
Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200
To further determine the safety and efficacy of Proellex in premenopausal women with uterine fibroids who have previously completed study ZPV-200.
- Trial name
- NCT01739621
- Testing
- Proellex 12 mg, Proellex 24 mg
- Volunteers
- 40 people
- Sponsor
- Repros Therapeutics Inc.
Uterine Fibroids
Post Market Evaluation of Acessa With TAG
The purpose of this study is to test both user preference and speed of targeting with the use of the Acessa System with Targeting Animation Guidance (TAG).
- Trial name
- TAG (NCT01842789)
- Testing
- Acessa Procedure
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Acessa Health, Inc.
Leiomyoma, Menorrhagia
A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids
The objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.
- Conditions
- Leiomyoma, Menorrhagia, Metrorrhagia
- Trial name
- NCT00160381
- Testing
- Asoprisnil
- Volunteers
- 432 people
- Sponsor
- Abbott
Uterine Fibroids
A Pharmacodynamic Study of Leuprorelin Gelatin-Free Formulation in Female Subjects With Uterine Fibroids.
The purpose of this study is to determine the pharmacodynamics of leuprorelin gelatin free formulation (GF) to leuprorelin gelatin containing formulation (GC) in female subjects with uterine fibroids.
- Trial name
- NCT00776074
- Testing
- Leuprorelin (GF), Leuprorelin (GC)
- Volunteers
- 80 people
- Sponsor
- Takeda
Uterine Fibroids
A Study to Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
The primary objective of this study is to describe the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal.
- Trial name
- ASTEROID 5 (NCT03240523)
- Testing
- Vilaprisan (BAY1002670)
- Where
- 139 sites in Australia, Austria and 21 more
- Volunteers
- 766 people
- Sponsor
- Bayer