Clinical trials: Uterine Fibroid
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 Leiomyomas, Endometrial Polyps
Symphion® System In-Office Study
The purpose of this study is to determine the safety and feasibility of using the Symphion system in an office setting.
- Trial name
- NCT02520414
- Testing
- Symphion® Bipolar Hysteroscopic Tissue Resection System
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Minerva Surgical, Inc.
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
Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in Premenopausal Women With Symptomatic Uterine Fibroids
Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months).
- Trial name
- NCT00735553
- Testing
- Proellex
- Where
- 15 sites in United States
- Volunteers
- 77 people
- Sponsor
- Repros Therapeutics Inc.
Uterine Fibroids, Polyps
HOME Study: Hysteroscopic Office Myomectomy Evaluation
The purpose of this study is to demonstrate safety and effectiveness of the MyoSure Tissue Removal System when used by community gynecologists in an office setting for the treatment of patients with symptomatic intrauterine…
- Trial name
- HOME (NCT01152112)
- Testing
- Myomectomy
- Where
- 9 sites in United States
- Volunteers
- 74 people
- Sponsor
- Hologic, Inc.
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.
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
Uterine Fibroids
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)
The primary objective of this study was to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo.
- Trial name
- NCT03400943
- Testing
- Vilaprisan (BAY1002670)
- Where
- 103 sites in United States, Bulgaria and 7 more
- Volunteers
- 93 people
- Sponsor
- Bayer
Leiomyoma, Uterine Hemorrhage
A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for 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
- NCT02147158
- Testing
- Ulipristal acetate (UPA)
- Where
- 63 sites in United States, Canada
- Volunteers
- 432 people
- Sponsor
- Allergan
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 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
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
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
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, 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
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
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
Uterine Fibroids
Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.
- Trial name
- NCT00683917
- Testing
- Proellex 25 mg, Proellex 50 mg, Lupron Depot
- Where
- 4 sites in United States, Mexico
- Volunteers
- 10 people
- Sponsor
- Repros Therapeutics Inc.
Uterine Fibroids
Therapeutic Magnetic Resonance Imaging (MRI)-Guided High Intensity Focused Ultrasound (HIFU) Ablation of Uterine Fibroids
This study is to confirm the safety and technical effectiveness of MRI guided High Intensity Focused Ultrasound (HIFU) in ablating uterine tissue associated with symptomatic leiomyomas.
- Trial name
- NCT00897897
- Testing
- Philips MRI-guided HIFU system
- Where
- 4 sites in France, Germany and 2 more
- Volunteers
- 33 people
- Sponsor
- Philips Healthcare
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