Clinical trials: Fibroids
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
Gynecologic Tumor
The Value of Advanced MR Imaging in Gynecological Tumors and Benign Uterine Fibroids
This research is being done to test new MRI methods called Magnetic Resonance Fingerprinting and Q-space Trajectory Imaging in gynecological abnormalities.
- Trial name
- NCT03993210
- Testing
- Magnetic Resonance Fingerprinting (MRF), Q-space Trajectory Imaging (QTI), Magnetic Resonance Imaging Machine (MRI)
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- Dana-Farber Cancer Institute
Uterine Fibroids, Adhesions
Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids
This study is designed to observe the presence or absence of intrauterine adhesions at 6 weeks after treatment with the Sonata® System through hysteroscopic evaluation by third party readers.
- Trial name
- OPEN (NCT02844920)
- Testing
- Intrauterine ultrasound guided radio-frequency ablation
- Where
- 6 sites in Germany, Netherlands and 2 more
- Volunteers
- 37 people
- Sponsor
- Gynesonics
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 Leiomyoma, Uterine Fibroids
Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
The objectives of this randomized withdrawal study are to evaluate the long-term efficacy and safety of the combination of relugolix, estradiol (E2) and norethindrone acetate (NETA), once daily, for up to 104 weeks in patients…
- Trial name
- NCT03751124
- Testing
- Relugolix, Estradiol/norethindrone acetate
- Where
- 104 sites in United States, Brazil and 6 more
- Volunteers
- 229 people
- Sponsor
- Myovant Sciences GmbH
Uterine Fibroids, Leiomyoma
Hysteroscopic Cryomyolysis for the Treatment of Submucosal Leiomyomata
The purpose of the current study is to evaluate the technical success, safety and procedure feasibility of hysteroscopic cryoablation treatment of symptomatic uterine fibroids in women who do not desire further pregnancies using…
- Conditions
- Uterine Fibroids, Leiomyoma, Menorrhagia
- Trial name
- NCT00731341
- Testing
- Cryoablation for the treatment of uterine fibroids
- Where
- Netherlands
- Volunteers
- 3 people
- Sponsor
- Boston Scientific Corporation
Leiomyoma
Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914
This study will evaluate whether the experimental drug ulipristal acetate can shrink uterine fibroids in pre-menopausal women.
- Trial name
- NCT00290251
- Testing
- ulipristal acetate 20 mg, ulipristal acetate 10 mg
- Where
- 2 sites in United States
- Volunteers
- 72 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leiomyoma
Superior Hypogastric Nerve Block for Pain Control Post-uterine Fibroid Embolization
Uterine fibroid embolization (UFE) is now an accepted treatment of uterine fibroids. However the procedure is often very painful and, in many centres, patients are admitted overnight with patient controlled analgesic (PCA) pumps…
- Trial name
- NCT02270255
- Testing
- Superior hypogastric nerve block, 0.75% Ropivacaine, Subcutaneous injection
- Where
- Canada
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
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
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, 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, 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.
Fibroids
Uterine Filling Pressure in Hysteroscopy
The aim of the study is to compare the outcomes of patients undergoing hysteroscopy with a MyoSure device with a pressure of 60 mmHg to those using the standard of 80 mmHg.
- Trial name
- NCT04550429
- Testing
- MyoSure Hysteroscopic Morcellator Device
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Northwestern University
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
Dysmenorrhea (Disorder), Dysmenorrhea Primary
Mechanistic Characterization of Uterine Pain
There are limited treatment options for management of dysmenorrhea, and the physiological processes they affect are not completely understood.
- Conditions
- Dysmenorrhea (Disorder), Dysmenorrhea Primary, Dysmenorrhea Secondary, Endometrial Diseases
- Trial name
- MCUP (NCT04145518)
- Testing
- Naproxen Sodium
- Where
- United States
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- Endeavor Health
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.
Fibroid Uterus, Pain, Postoperative
Pre-incisional Wound INfiltration and Hypogastric PLEXus Block Using Ropivacaine in Laparoscopic Myomectomy
The purpose of this study is to assess an impact of laparoscopic superior hypogastric plexus (SHP) block combined with preemptive troacar site infiltration on postoperative pain intensity following laparoscopic myomectomy.
- Trial name
- WINPLEX (NCT06429163)
- Testing
- Troacar site infiltration, Superior hypogastric plexus block
- Where
- Russia
- Volunteers
- 207 people
- Sponsor
- Saint Petersburg State University, Russia
Uterine Fibroids
A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
The main objective of this study is to assess safety and efficacy of elagolix compared to placebo in reducing heavy menstrual bleeding (HMB) associated with uterine fibroids in premenopausal women.
- Trial name
- NCT03886220
- Testing
- Elagolix
- Where
- 48 sites in United States, Puerto Rico
- Volunteers
- 82 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, 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.