Clinical trials: Fibromyoma
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
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
Evaluation of Safety, Pharmacokinetics, and Efficacy of Proellex Administered Vaginally in Women With Uterine Fibroids
To determine the safety, pharmacokinetics and efficacy of 4 doses (3, 6, 12, 24 mg) of Proellex in premenopausal women with uterine fibroids confirmed by ultrasound. Drug will be administered vaginally.
- Trial name
- NCT01451424
- Testing
- Proellex
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Repros Therapeutics 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
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
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
Uterine Leiomyoma, Uterine Fibroids
MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication
This is a phase 3 study to determine the safety of the new features to the FDA approved ExAblate device using a new method to ablate fibroids deemed Enhanced Sonication.
- Trial name
- NCT00365989
- Testing
- ExAblate Enhanced Sonication
- Where
- 5 sites in United States, Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- InSightec
Leiomyoma, Uterine Fibroids
A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)
The purpose of this study is to demonstrate comparability between Contour SE™ Microspheres and Embosphere® Microspheres for achieving post UFE fibroid devascularization in women with symptomatic uterine fibroids.
- Conditions
- Leiomyoma, Uterine Fibroids, Uterine Neoplasms, Menorrhagia
- Trial name
- NCT00628901
- Testing
- Uterine Fibroid Embolization (UFE), Contour SE™ Microspheres, Embosphere® Microspheres
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Boston Scientific Corporation
Uterine Fibroids
Evaluating the Safety and Efficacy of Proellex® 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
- NCT00853567
- Testing
- Proellex
- Where
- 17 sites in United States
- Volunteers
- 71 people
- Sponsor
- Repros Therapeutics Inc.
Uterine Fibroids, With Unexplained Infertility
ExAblate Treatment of Uterine Fibroids for Fertility Enhancement
The objective of this trial is to evaluate the efficacy and safety of the ExAblate 2000 system for enhancement of fertility in women with non-hysteroscopically resectable uterine fibroids, who are diagnosed with unexplained…
- Trial name
- NCT00730886
- Testing
- ExAblate 2000, Myomectomy
- Where
- 6 sites in United States
- Volunteers
- 2 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, 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
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.
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 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.
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, 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.
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