Clinical trials: Soft Tissue Bleeding
Menorrhagia
Sonography Guided Transcervical Ablation of Uterine Fibroids
The objective of this study is to establish the safety and effectiveness of the Sonata® System in the treatment of symptomatic uterine fibroids.
- Trial name
- SONATA (NCT02228174)
- Testing
- Intrauterine Ultrasound-Guided Radiofreq. Ablation System
- Where
- 23 sites in United States, Mexico
- Volunteers
- 147 people
- Sponsor
- Gynesonics
Hemorrhage, Soft Tissue Bleeding
The EVARREST® Paediatric Mild/Moderate Liver and Soft Tissue Bleeding Study
The objective of this study is to evaluate the safety and effectiveness of EVARREST™ Sealant Matrix (EVARREST™ Fibrin Sealant Patch) (EVARREST™) in controlling mild or moderate soft tissue \& parenchymal bleeding during open…
- Conditions
- Hemorrhage, Soft Tissue Bleeding, Hepatic Parenchyma Bleeding
- Trial name
- NCT02227992
- Testing
- EVARREST™ Sealant Matrix, SURGICEL®
- Where
- 10 sites in Belgium, United Kingdom
- Volunteers
- 40 people
- Sponsor
- Ethicon, Inc.
Non-emergent, Soft Tissue Procedures, Performed Via an Open Approach
A Prospective, Multi-Center, Single-Arm Study of the Veriset™ Hemostatic Patch in Controlling Bleeding in Soft Tissue
The objective of this study is to determine the safety of Veriset™ Hemostatic Patch when used during non-emergent, open, soft tissue surgery where a topical hemostatic agent would be used.
- Trial name
- NCT01719172
- Testing
- Veriset™ Hemostatic Patch
- Where
- 3 sites in Austria, Germany
- Volunteers
- 30 people
- Sponsor
- Medtronic - MITG
Uterine Fibroids, Heavy Menstrual Bleeding
Efficacy and Safety of BG2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids.
The primary objective of this study is to demonstrate the superior efficacy versus placebo of BG2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in…
- Trial name
- NCT05620355
- Testing
- BG2109, Add-back therapy
- Where
- 29 sites in China
- Volunteers
- 312 people
- Sponsor
- Bio Genuine (Shanghai) Biotech Co., Ltd.
Uterine Fibroids, Heavy Menstrual Bleeding
Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
The primary objective of this study is to demonstrate the superior efficacy versus placebo of OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids…
- Trial name
- PRIMROSE 2 (NCT03070951)
- Testing
- OBE2109, Add-back
- Where
- 96 sites in United States, Bulgaria and 7 more
- Volunteers
- 511 people
- Sponsor
- ObsEva SA
Hemostasis
The Fibrin Patch Soft Tissue Study
The effectiveness objective of this study is to evaluate whether Fibrin Patch is superior to SURGICEL™ as an adjunct to achieving hemostasis during surgical procedures involving soft tissue bleeding in abdominal, pelvic…
- Trial name
- NCT00658723
- Testing
- Fibrin Pad, SURGICEL™
- Where
- 11 sites in United States
- Volunteers
- 141 people
- Sponsor
- Ethicon, Inc.
Hemorrhage
SURGICEL® Powder in Controlling Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding in Adult Subjects
This is a prospective, single arm, multicentre, multispecialty, post market, clinical study evaluating SURGICEL Powder as an adjunct to achieve haemostasis (control bleeding) when conventional methods of control are impractical…
- Trial name
- NCT03762200
- Testing
- SURGICEL Powder
- Where
- 8 sites in Belgium, United Kingdom
- Volunteers
- 103 people
- Sponsor
- Ethicon, Inc.
Fibroid Uterus, Leiomyoma
Study of Asoprisnil in the Treatment of Uterine Fibroids.
The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.
- Conditions
- Fibroid Uterus, Leiomyoma, Menorrhagia, Metrorrhagia
- Trial name
- NCT00156156
- Testing
- Asoprisnil
- Volunteers
- 149 people
- Sponsor
- Abbott
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.
Heavy Menstrual Bleeding, Uterine Fibroids
Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
The goal of this clinical trial is to determine the benefit of relugolix 40 milligrams (mg) once a day compared with placebo in heavy menstrual bleeding associated with uterine fibroids.
- Trial name
- NCT06671548
- Testing
- Relugolix
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Controlling Mild to Moderate Bleeding During Surgery
The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study
The objective of this study is to evaluate the safety and hemostatic effectiveness of EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue bleeding during open hepatic, abdominal, pelvic…
- Trial name
- NCT03255174
- Testing
- EVARREST® Fibrin Sealant Patch
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Ethicon, Inc.
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
Leiomyoma, Uterine Fibroids
Fibroid Ablation Study
The primary objective of this study is to establish the effectiveness and confirm the safety of the VizAblate System in ablating symptomatic uterine fibroids.
- Conditions
- Leiomyoma, Uterine Fibroids, Menorrhagia
- Trial name
- FAST-EU (NCT01226290)
- Testing
- VizAblate System
- Where
- 10 sites in Mexico, Netherlands and 1 more
- Volunteers
- 51 people
- Sponsor
- Gynesonics
Heavy Menstrual Bleeding, Uterine Fibroid
LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
The purpose of this study was to determine the long-term efficacy and safety of relugolix 40 milligrams (mg) once daily co-administered with estradiol (E2) and norethindrone acetate (NETA) for 28 weeks on heavy menstrual bleeding…
- Trial name
- NCT03412890
- Testing
- Relugolix, Estradiol/norethindrone acetate
- Where
- 150 sites in United States, Belgium and 7 more
- Volunteers
- 477 people
- Sponsor
- Myovant Sciences GmbH
Leiomyoma, Menorrhagia
Treatment of Uterine Fibroids With Asoprisnil(J867)
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
- NCT00152269
- Testing
- Asoprisnil
- Volunteers
- 475 people
- Sponsor
- Abbott
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
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)
The primary objective of this study was to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo The secondary objectives of this study were to…
- Trial name
- NCT03400956
- Testing
- Vilaprisan (BAY1002670)
- Where
- 87 sites in United States, Czechia and 3 more
- Volunteers
- 103 people
- Sponsor
- Bayer
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
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
This is a phase III, multicentre, long-term open-label extension of the phase III study: Pearl IIIextension (PGL09-027). During Pearl III (PGL09-026) and subsequent Pearl III extension (PGL09-027), patients have been exposed to a…
- Trial name
- PEARLext2 (NCT01642472)
- Testing
- Ulipristal Acetate - open label
- Where
- 16 sites in Austria, Belgium and 2 more
- Volunteers
- 64 people
- Sponsor
- PregLem SA
Heavy Menstrual Bleeding, Uterine Fibroid
LIBERTY 1: 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
- NCT03049735
- Testing
- Relugolix, Estradiol/norethindrone acetate
- Where
- 110 sites in United States, Brazil and 4 more
- Volunteers
- 388 people
- Sponsor
- Myovant Sciences GmbH