Clinical trials: Uterine Leiomyomas
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
ExAblate UF V2 System for the Treatment of Symptomatic Uterine Fibroids
The purpose of this study is to evaluate the safety and ablation efficacy of the ExAblate UF V2 System when treating symptomatic uterine fibroids.
- Trial name
- NCT01285960
- Testing
- ExAblate Treatment UF V2
- Where
- 8 sites in United States
- Volunteers
- 108 people
- Sponsor
- InSightec
Uterine Fibroids, Abnormal Uterine Bleeding
Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?
The objective aim is to evaluate whether the use of 3D laparoscopy facilitates the vaginal cuff closure of the vaginal cuff during a total laparoscopic hysterectomy among novice laparoscopists (PGY 2-4, Fellow).
- Conditions
- Uterine Fibroids, Abnormal Uterine Bleeding, Pelvic Pain, Adenomyosis
- Trial name
- 3DRCT (NCT02192606)
- Testing
- Storz 3D Laparoscopy System, 2D Laparoscopy
- Where
- 2 sites in United States, Denmark
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
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 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
Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids
The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.
- Trial name
- NCT00737282
- Testing
- Proellex 25 mg, Proellex 50 mg
- Where
- 25 sites in United States
- Volunteers
- 175 people
- Sponsor
- Repros Therapeutics Inc.
Uterine Fibroids
Safety and Efficacy of Telapristone Acetate (Proellex®) Administered Vaginally for the Treatment of Uterine Fibroids
The primary objective of this study is to determine the safety and efficacy of two vaginal doses of Proellex® administered for up to 2 courses of treatment (18 weeks each), each separated by an Off-Drug Interval (ODI), to…
- Trial name
- NCT02323646
- Testing
- Telapristone Acetate
- Where
- 8 sites in United States
- Volunteers
- 42 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
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.
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
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.
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
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
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
Cancer Debulking, Enlarged Uterus
Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy
To determine if opioid consumption postoperatively among patients undergoing non-emergent laparotomy by the gynecologic oncology service who receive intrathecal morphine with intraoperative lidocaine (IML) infusion are lower than…
- Conditions
- Cancer Debulking, Enlarged Uterus, Fibroid Uterus, Adnexal Mass
- Trial name
- NCT05017246
- Testing
- Bupivacaine, Morphine, Lidocaine
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Washington University School of Medicine
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
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, 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 Fibroid, Arteriovenous Malformations
An Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres
This registry study is designed to collect data on the procedural success and complication rates in real-world patients undergoing HydroPearl embolization procedures via radial access.
- Conditions
- Uterine Fibroid, Arteriovenous Malformations, Hypervascular Tumors, Benign Prostatic Hyperplasia
- Trial name
- RAVI Registry (NCT04272216)
- Testing
- Treatment with HydroPearl via radial access
- Where
- 6 sites in United States
- Volunteers
- 99 people
- Sponsor
- Terumo Medical Corporation
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