Clinical trials: Fibroid
Heavy Uterine Bleeding, Uterine Fibroids
Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids
The purpose of this proof-of-concept study is to assess the safety and effectiveness of elagolix versus placebo to reduce uterine bleeding associated with uterine fibroids, and to reduce fibroid volume and uterine volume in…
- Trial name
- NCT01441635
- Testing
- Elagolix, Estradiol/Norethindrone acetate (E2/NETA), Estradiol
- Volunteers
- 271 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
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
Uterine Fibroids
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
The study was performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care
- Trial name
- ASTEROID 6 (NCT03194646)
- Testing
- Vilaprisan (BAY1002670), Standard of care
- Where
- 219 sites in United States, China and 11 more
- Volunteers
- 1,272 people
- Sponsor
- Bayer
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
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.
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
Heavy Menstrual Bleeding, Menorrhagia
Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids
This is a randomized controlled trial (RCT) to assess the comparative effectiveness of Levonorgestrel Intrauterine System (LNG-IUS) to Tranexamic Acid (TA) for the treatment of heavy menstrual bleeding (HMB) in women with…
- Conditions
- Heavy Menstrual Bleeding, Menorrhagia, Uterine Fibroids
- Trial name
- NCT03317795
- Testing
- Levonorgestrel IUS, Tranexamic Acid
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Shannon K. Laughlin-Tommaso
Uterine Fibroids
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
Phase III, multicentre, randomized, double-blind, parallel group, long-term study investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment of uterine myoma.
- Trial name
- PEARLIV (NCT01629563)
- Testing
- PGL4001 5 mg, PGL4001 10 mg
- Where
- 49 sites in Belgium, Czechia and 9 more
- Volunteers
- 451 people
- Sponsor
- PregLem SA
Uterine Fibroids
Embozene Microspheres for Uterine Fibroid Embolization (UFE)
This is a randomized, prospective, multi-center study of 225 female subjects age 30-50 years with symptoms from uterine fibroids.
- Trial name
- NCT01675011
- Testing
- Embozene® Microspheres, Embosphere®
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Boston Scientific Corporation
Uterine Fibroids, Anemia
Safety and Efficacy of Proellex in Pre-Menopausal Anemic Women With Symptomatic Uterine Fibroids
Subjects will be randomly assigned to one of 3 treatment groups and receive 325 mg (65 mg elemental iron) iron supplements twice daily.
- Trial name
- NCT00785356
- Testing
- Proellex 25 mg, Proellex 50 mg
- Where
- 7 sites in Mexico
- Volunteers
- 8 people
- Sponsor
- Repros Therapeutics Inc.
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
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
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.
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.
Leiomyoma
Magnetic Resonance (MR) Guided Focused Ultrasound Surgery of Uterine Fibroids
The goal of this study is to develop additional long term data to evaluate the safety and effectiveness of this treatment. Indications for use for this system is: 'The ExAblate is intended to ablate uterine fibroid tissue in pre…
- Trial name
- NCT00131365
- Testing
- ExAblate 2000
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- InSightec
Leiomyoma
Dexamethasone for Post Uterine Artery Embolization Pain
The purpose of this research is to investigate if administration steroids (anti-inflammatory medication) via the uterine arteries during uterine fibroid embolization (A non surgical procedure for treating uterine fibroids by…
- Trial name
- Dex-Fib (NCT04655144)
- Testing
- Dexamethasone, Saline
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- University of Miami
Uterine Fibroids
Safety Study of ExAblate for the Treatment of Uterine Fibroids
The objective of this Phase IV study is to evaluate the safety of the ExAblate treatment of uterine fibroids using the enhanced sonication techniques, based on the current commercially-approved treatment guidelines.
- Trial name
- NCT01142791
- Testing
- ExAblate
- Where
- 8 sites in United States
- Volunteers
- 121 people
- Sponsor
- InSightec