Clinical trials: Fibroids
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.
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
Abnormal Uterine Bleeding, Infertility
Clinical Evaluation of the Interlace Medical Hysteroscopic Morcellator
This study assesses the effectiveness of intrauterine fibroid and polyp removal using the Interlace Medical 1st generation hysteroscopic morcellator device based on a retrospective review of medical records of women who have been…
- Trial name
- NCT01026805
- Testing
- Interlace Medical 1st Generation Hysteroscopic Morcellator
- Volunteers
- 11 people
- Sponsor
- Hologic, Inc.
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)
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
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.
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)
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
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
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
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
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
Symptomatic Uterine Fibroids and Adenomyosis
Effectiveness of IV Acetaminophen and IV Ibuprofen in Reducing Post Procedural Pain in the UFE Procedure
The uterine fibroid embolization (UFE) procedure is a treatment option for abnormal heavy menstrual bleeding and/or bulk symptoms associated with uterine fibroids and adenomyosis.
- Trial name
- NCT02227316
- Testing
- IV Ibuprofen, IV Acetaminophen
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- University of California, Los Angeles
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, 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, 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.
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
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, Uterine Leiomyomata
Pilot Study of MRI-Guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids
Uterine fibroids (leiomyomas) are a common cause of heavy uterine bleeding and pain in reproductive aged women and are the most common cause of hysterectomy in the United States.
- Trial name
- NCT00837161
- Testing
- Philips MR guided HIFU system
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- Philips Healthcare
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.