| 1 |
NCT00821275 |
Enrolling by invitation |
Clinical Trial of Uterine Artery Embolization for Uterine Leiomyoma |
|
- Procedure: Interventional radiological or surgical management
|
Interventional |
Phase 2
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- quality of life
- pregnant
- tumor recurrence
- (and 4 more...)
|
900 |
Female |
20 Years to 50 Years (Adult) |
NCT00821275 |
2007026 |
|
January 2008 |
December 2018 |
December 2018 |
January 13, 2009 |
January 13, 2009 |
|
- Nanfang Hospital of Nanfang medical University
Guangzhou, Guangdong, China - Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China - the first Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China - Sun Yat-sen University
Guangzhou, Guangdong, China
|
| 2 |
NCT01588899 |
Completed |
China Clinical Trial for Therapeutic MR-HIFU Ablation of Uterine Fibroids |
|
- Device: MR-HIFU uterine fibroid treatment
|
Interventional |
Not Applicable |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in fibroid volume
- Adverse Events
|
107 |
Female |
18 Years to 55 Years (Adult) |
NCT01588899 |
907764 |
|
May 2012 |
December 2014 |
May 2015 |
May 1, 2012 |
October 22, 2015 |
|
- Peking University First Hospital
Beijing, Beijing, China - First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, China
|
| 3 |
NCT01504308 |
Terminated |
Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids |
|
- Device: MR-HIFU treatment
- Device: Sham treatment
|
Interventional |
Phase 2
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Alternative Interventional Treatment (AIT)
- Menstrual Blood Loss (MBL)
- Return to Activity
- Symptom Severity Score (SSS)
|
49 |
Female |
18 Years to 50 Years (Adult) |
NCT01504308 |
994045
G110008 |
SOFIA |
May 2012 |
March 2016 |
March 2016 |
January 5, 2012 |
April 5, 2017 |
|
- University of Chicago
Chicago, Illinois, United States - University of Michigan
Ann Arbor, Michigan, United States - Montefiore Medical Center
Bronx, New York, United States - (and 6 more...)
|
| 4 |
NCT00133705 |
Completed
Has Results |
Trial of Mifepristone for Fibroids |
|
- Drug: Mifepristone
- Drug: Inert Capsule
|
Interventional |
Phase 3 |
- University of Rochester
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
|
70 |
Female |
18 Years and older (Adult, Senior) |
NCT00133705 |
RO1-HD042578-2 |
|
July 2003 |
June 2010 |
June 2010 |
August 23, 2005 |
March 14, 2014 |
November 30, 2012 |
- University of Rochester School of Medicine & Dentistry
Rochester, New York, United States
|
| 5 |
NCT03021720 |
Recruiting |
Satisfaction of Patients With Trans-Arterial Radial Access: Quality of Life in Uterine Fibroid Embolization Trial |
|
- Procedure: Arterial access
|
Interventional |
Not Applicable |
- Mount Sinai Hospital, Canada
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
|
- Patient satisfaction
- Procedure related complication rate
- Procedure Time
- (and 3 more...)
|
52 |
Female |
18 Years and older (Adult, Senior) |
NCT03021720 |
16-0227-A |
SPARQLE |
November 2016 |
November 2018 |
November 2018 |
January 16, 2017 |
January 16, 2017 |
|
- Mount Sinai Hospital
Toronto, Ontario, Canada - University Health Network
Toronto, Ontario, Canada
|
| 6 |
NCT02189083 |
Unknown † |
Study of Tumor-shrinking Decoction (TSD) to Treat Symptomatic Uterine Fibroids |
|
|
Interventional |
Phase 3 |
- The University of Hong Kong
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Changes in the score of Uterine Fibroid Symptom and Quality of Life questionnaire (UFS-QOL) from Baseline to 6 months
- Change of clinical response from baseline on the the symptom severity of transformed UFS-QOL score
- Imaging outcomes
- Serum concentrations of estrogen and follicle-stimulating hormone
|
78 |
All |
18 Years to 52 Years (Adult) |
NCT02189083 |
HKU-SCM-TSD2014
HMRF-11121841 |
|
May 2014 |
November 2015 |
February 2016 |
July 14, 2014 |
July 14, 2014 |
|
- School of Chinese Medicine, University of Hong Kong
Hong Kong, China
|
| 7 |
NCT00100191 |
Completed |
Emmy Trial: Uterine Artery Embolization (UAE) Versus Hysterectomy for Uterine Fibroids |
- Menorrhagia
- Leiomyoma
- Uterine Neoplasms
|
- Procedure: uterine artery embolization
- Procedure: hysterectomy
|
Interventional |
Phase 3 |
- ZonMw: The Netherlands Organisation for Health Research and Development
- Boston Scientific Corporation
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The primary endpoint is the normalization of menorrhagia after a two-year follow-up period
- Effect on complaints of pain and pressure
- Technical failure
- (and 5 more...)
|
120 |
Female |
18 Years and older (Adult, Senior) |
NCT00100191 |
NWO-DO 945-01-17 |
|
February 2002 |
|
April 2006 |
December 24, 2004 |
June 24, 2005 |
|
- Academic Medical Centre Amsterdam
Amsterdam, Netherlands - 27 Other Participating Hospitals of Varying Sizes Throughout the Country
Amsterdam, Netherlands
|
| 8 |
NCT03194646 |
Recruiting |
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids |
|
- Drug: Vilaprisan (BAY1002670)
- Other: Standard of care
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage change in bone mineral density (BMD) of lumbar spine
- Number of bleeding days
|
1050 |
Female |
18 Years and older (Adult, Senior) |
NCT03194646 |
16953
2016-004822-41 |
ASTEROID 6 |
June 30, 2017 |
November 27, 2021 |
November 27, 2021 |
June 21, 2017 |
April 24, 2018 |
|
- Central Research Associates, Inc.
Birmingham, Alabama, United States - Women's Health Alliance of Mobile
Mobile, Alabama, United States - Coastal Clinical Research, Inc
Mobile, Alabama, United States - (and 257 more...)
|
| 9 |
NCT03400956 |
Recruiting |
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4) |
|
- Drug: Vilaprisan (BAY1002670)
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Amenorrhea (yes/no)
- HMB response
- Time to onset of amenorrhea
- (and 4 more...)
|
156 |
Female |
18 Years and older (Adult, Senior) |
NCT03400956 |
15790
2016-003561-26 |
|
January 24, 2018 |
April 1, 2020 |
April 1, 2020 |
January 17, 2018 |
April 17, 2018 |
|
- Central Research Associates, Inc.
Birmingham, Alabama, United States - Clearview Medical Research, LLC
Canyon Country, California, United States - Diagnamics, Inc.
Encinitas, California, United States - (and 97 more...)
|
| 10 |
NCT03400943 |
Recruiting |
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3) |
|
- Drug: Vilaprisan (BAY1002670)
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Amenorrhea (yes/no)
- Time to onset of amenorrhea
- Time to onset of controlled bleeding
- (and 4 more...)
|
260 |
Female |
18 Years and older (Adult, Senior) |
NCT03400943 |
15787
2017-002997-38 |
|
January 17, 2018 |
May 20, 2020 |
May 20, 2020 |
January 17, 2018 |
April 24, 2018 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - New Horizons Women's Care
Chandler, Arizona, United States - Retina Institute of California
Arcadia, California, United States - (and 124 more...)
|
| 11 |
NCT01840124 |
Active, not recruiting |
Uterine Leiomyoma Treatment With Radiofrequency Ablation |
|
- Device: Radiofrequency ablation of fibroids
|
Interventional |
Not Applicable |
- University of California, San Francisco
- University of California, Davis
- University of California, Irvine
- (and 2 more...)
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Changes in fibroid-related symptoms after the Acessa procedure.
- Re-intervention for recurrent fibroid symptoms following the Acessa procedure.
- Operative complications
- Pregnancy after the Acessa procedure
|
100 |
Female |
21 Years and older (Adult, Senior) |
NCT01840124 |
13-11026 |
ULTRA |
July 2013 |
June 2019 |
June 2019 |
April 25, 2013 |
February 6, 2018 |
|
- University of California, Davis
Davis, California, United States - University of California, Irivine
Irvine, California, United States - University of California, San Diego
La Jolla, California, United States - (and 2 more...)
|
| 12 |
NCT03342859 |
Recruiting |
Mode of Action Study of Vilaprisan and Ulipristal Acetate in Patients With Uterine Fibroids for Whom Hysterectomy is Planned |
|
- Drug: Vilaprisan, BAY1002670
- Drug: Ulipristal
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Other
|
- a biomarker for glandular and stromal cell proliferation (Ki-67) in the endometrium of the same patient before treatment and when treated with VPR (vilaprisan) prior to surgery
- a biomarker for myoma cell proliferation (Ki-67) in fibroid tissue of patients not treated with PRM (progesterone receptor modulator )and those who have been treated with VPR prior to surgery
- biomarkers for apoptotic regulation in the endometrium (BCL-2 (B-cell lymphoma 2), caspase 3) of the same patient before treatment and when treated with VPR prior to surgery
- (and 3 more...)
|
55 |
Female |
18 Years and older (Adult, Senior) |
NCT03342859 |
15791
2017-000468-13 |
|
November 16, 2017 |
July 30, 2019 |
September 6, 2019 |
November 17, 2017 |
April 6, 2018 |
|
- Edinburgh Royal Infirmary/ NHS Lothian
Edinburgh, United Kingdom - Forth Valley Royal Hospital
Larbert, United Kingdom
|
| 13 |
NCT03509168 |
Recruiting
New |
The Efficacy and Safety of Preoperative Misoprostol in Blood-loss Reduction During Myomectomy. |
|
- Drug: Misoprostol Pfizer Brand
- Other: Non-insertion of Misoprostol Pfizer Brand
|
Interventional |
Phase 2
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Care Provider)
- Primary Purpose: Treatment
|
- intraoperative blood loss during open myomectomy in milliliters
- duration of surgery
- duration of hospital stay
- (and 3 more...)
|
46 |
Female |
15 Years to 49 Years (Child, Adult) |
NCT03509168 |
myomectomy trial |
MM |
January 10, 2018 |
May 30, 2018 |
June 3, 2018 |
April 26, 2018 |
April 26, 2018 |
|
- Makerere University
Kampala, Central, Uganda
|
| 14 |
NCT02100904 |
Recruiting |
Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry |
|
- Procedure: Radiofrequency ablation of fibroids
|
Observational |
|
- University of California, San Francisco
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Changes in fibroid-related symptoms after the Acessa procedure.
- Rate of re-intervention for recurrent fibroid symptoms following the Acessa procedure.
- Operative complications
- Pregnancy rate after the Acessa procedure.
|
200 |
Female |
21 Years and older (Adult, Senior) |
NCT02100904 |
14-13325 |
ULTRA Registry |
May 2014 |
January 2022 |
January 2022 |
April 1, 2014 |
April 4, 2018 |
|
- University of California, San Francisco
San Francisco, California, United States - Gynecology Institute of Chicago
Chicago, Illinois, United States - UT Southwestern
Dallas, Texas, United States - MacArthur Medical Center
Irving, Texas, United States
|
| 15 |
NCT03240523 |
Recruiting |
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Compare to Ulipristal |
|
- Drug: Vilaprisan (BAY1002670)
- Other: Matching placebo to ulipristal
- Other: Matching placebo to vilaprisan
- Drug: Ulipristal (Esmya)
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Amenorrhea (yes/no)
- Absence of bleeding (yes/no)
- Number of bleeding days
- (and 5 more...)
|
996 |
Female |
18 Years and older (Adult, Senior) |
NCT03240523 |
15789
2016-002855-48 |
ASTEROID 5 |
July 31, 2017 |
September 28, 2021 |
September 28, 2021 |
August 7, 2017 |
April 13, 2018 |
|
- Paratus Clinical Pty Ltd
Blacktown, New South Wales, Australia - Paratus Clinical Wyong Complex
Kanwal, New South Wales, Australia - Women's Health and Research Institute of Australia-WHRIA
Sydney, New South Wales, Australia - (and 205 more...)
|
| 16 |
NCT01377519 |
Completed |
Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids |
|
- Procedure: MR Guided Focused Ultrasound
- Procedure: Placebo MR Guided Focused Ultrasound
|
Interventional |
Not Applicable |
- University of California, San Francisco
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Fibroid volume measured on MRI
- Fibroid symptoms reported by participant
- Red blood cell count (hematocrit)
|
20 |
Female |
18 Years and older (Adult, Senior) |
NCT01377519 |
001 |
PROMISe |
June 2011 |
September 2012 |
December 2012 |
June 21, 2011 |
January 16, 2014 |
|
- University of California, San Francisco
San Francisco, California, United States
|
| 17 |
NCT00897897 |
Completed
Has Results |
Therapeutic Magnetic Resonance Imaging (MRI)-Guided High Intensity Focused Ultrasound (HIFU) Ablation of Uterine Fibroids |
|
- Device: Philips MRI-guided HIFU system
|
Interventional |
Not Applicable |
- Philips Healthcare
- Philips Medical Systems
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Adverse Events/Subject Resulting From HIFU Treatment of the Uterine Fibroids
- Fibroid Symptom Severity Score (SSS) From the Uterine Fibroid Symptoms - Quality of Life (UFS-QoL) Questionnaire.
|
33 |
Female |
18 Years to 59 Years (Adult) |
NCT00897897 |
996233 |
|
April 2009 |
December 2009 |
December 2009 |
May 12, 2009 |
December 4, 2012 |
November 11, 2011 |
- Hospital St. Andre
Bordeaux, France - University Hospital Schleswig-Holstein
Lübeck, Germany - Samsung Medical Center
Seoul, Korea, Republic of - University Medical Center
Utrecht, Netherlands
|
| 18 |
NCT01064960 |
Completed |
Therapeutic MRI-HIFU Ablation of Uterine Fibroids in a 3T MRI Scanner |
|
- Device: Philips MR-guided HIFU system
|
Interventional |
Phase 3 |
- Philips Healthcare
- Philips Medical Systems
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety of HIFU for treatment of the uterine fibroids as determined by adverse event reporting.
- Technical efficacy of HIFU for treatment of uterine fibroids as assessed by a change in the Symptom Severity Score
- Change in Quality of Life Scores
- (and 2 more...)
|
7 |
Female |
18 Years to 59 Years (Adult) |
NCT01064960 |
997677 |
|
January 2010 |
July 2011 |
July 2011 |
February 9, 2010 |
December 4, 2012 |
|
- Oslo University Hospital
Oslo, Norway
|
| 19 |
NCT01738724 |
Unknown † |
Study of the Efficacy of Dienogest in the Treatment of Uterine Leiomyomas When Compared to Desogestrel and Goserelin |
|
- Drug: Dienogest
- Drug: Goserelin
- Drug: Desogestrel
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Leiomyoma Volume
- Pictorial Blood Assessment Chart (PBAC) Score Reduction
- Number of episodes of vaginal bleeding
|
63 |
Female |
35 Years to 55 Years (Adult) |
NCT01738724 |
FMRPUSP-UROGIN-002 |
|
January 2013 |
August 2013 |
December 2013 |
November 30, 2012 |
November 30, 2012 |
|
|
| 20 |
NCT03317795 |
Recruiting |
Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids |
- Heavy Menstrual Bleeding
- Menorrhagia
- Uterine Fibroids
|
- Drug: Levonorgestrel IUS
- Drug: Tranexamic Acid
|
Interventional |
Phase 4 |
- Shannon K. Laughlin-Tommaso
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Mayo Clinic
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in Self-Reported Menorrhagia Scores
- Duration of Use of Assigned Treatment
- Mean Fibroid Size
- (and 4 more...)
|
160 |
Female |
25 Years to 50 Years (Adult) |
NCT03317795 |
16-008671
R21HD091337 |
|
November 14, 2017 |
June 30, 2019 |
December 31, 2019 |
October 23, 2017 |
April 3, 2018 |
|
- Mayo Clinic in Rochester
Rochester, Minnesota, United States
|
| 21 |
NCT01786226 |
Terminated |
Mifepristone to Treat Uterine Fibroids |
|
- Drug: Oral administration of mifepristone 2.5 mg daily for three months
- Drug: Oral administration of mifepristone 5 mg daily for three months
|
Interventional |
Phase 2
Phase 3 |
- Mediterranea Medica S. L.
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Volume of the uterine leiomyomata with 2,5mg vs 5 mg daily of mifepristone after 3 months of treatment
- Volume of the uterus with 2,5 mg vs 5 md daily of mifepristone after 3 months of treatment.
|
220 |
Female |
18 Years to 50 Years (Adult) |
NCT01786226 |
Fibroma2.5normal |
|
March 2010 |
March 2012 |
March 2012 |
February 7, 2013 |
September 5, 2014 |
|
- Hospital Eusebio Hernández
Ciudad Habana, Havana, Cuba
|
| 22 |
NCT00712595 |
Completed |
Mifepristone for Treatment of Uterine Fibroids |
|
|
Interventional |
Phase 2
Phase 3 |
- Mediterranea Medica S. L.
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Volume of the uterine leiomyomata with 5 mg versus 10 mg daily of mifepristone after 3 months of treatment
- Volume of the uterus with 5 mg versus 10 mg daily of mifepristone after 3 months of treatment
|
200 |
Female |
18 Years to 50 Years (Adult) |
NCT00712595 |
Mife_Fibroids_01 |
Mifemyo |
January 2007 |
January 2007 |
March 2009 |
July 10, 2008 |
April 23, 2009 |
|
- Hospital Eusebio Hernández
Havana, Ciudad Habana, Cuba
|
| 23 |
NCT01347385 |
Unknown † |
Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy |
|
- Procedure: Laparoscopic myomectomy with unidirectional barbed suture
- Procedure: Traditional suture material
|
Interventional |
Not Applicable |
- Sunnybrook Health Sciences Centre
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Operative time
- Blood loss
- Adverse events
- (and 2 more...)
|
80 |
Female |
Child, Adult, Senior |
NCT01347385 |
MIS-1 |
|
January 2012 |
January 2014 |
|
May 4, 2011 |
May 4, 2011 |
|
- Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
|
| 24 |
NCT00180739 |
Completed |
Safety Trial of Magnetic Resonance (MR) Guided Focused Ultrasound Surgery (FUS) in Women With Uterine Fibroids Wishing to Pursue Pregnancy in the Future |
- Uterine Fibroids
- Pregnancy
|
- Procedure: Magnetic Resonance Guided Focused Ultrasound
|
Interventional |
Phase 4 |
- Imperial College London
- InSightec
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pregnancy outcomes in women who have received treatment with MRgFUS
- Efficacy of MRgFUS as judged by HRQOL questionnaires
|
60 |
Female |
20 Years to 45 Years (Adult) |
NCT00180739 |
UF004 |
|
April 2004 |
|
|
September 16, 2005 |
August 13, 2008 |
|
- St Mary's Hospital
London, United Kingdom
|
| 25 |
NCT03476928 |
Recruiting |
A Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding |
- Uterine Fibroids and Heavy Menstrual Bleeding
|
- Drug: Vilaprisan (BAY1002670)
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of treatment-emergent adverse event
- Number of bleeding days
|
188 |
Female |
18 Years and older (Adult, Senior) |
NCT03476928 |
19435 |
ASTEROID 8 |
March 30, 2018 |
November 10, 2020 |
November 10, 2020 |
March 26, 2018 |
April 25, 2018 |
|
- Meitetsu Hospital
Nagoya, Aichi, Japan - Kano's Clinic for Women
Nagoya, Aichi, Japan - Kyoritsu Narashinodai Hospital
Funabashi, Chiba, Japan - (and 23 more...)
|
| 26 |
NCT00886873 |
Completed |
Mifepristone 10 or 5 mg for 6 Months to Treat Uterine Fibroids |
|
|
Interventional |
Phase 2
Phase 3 |
- Mediterranea Medica S. L.
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Volume of the uterine leiomyomata with 5 versus 10 mg of mifepristone daily after six months of treatment
- Prevalence of symptoms after 6 months treatment with 5 or 10 mg of mifepristone.
|
100 |
Female |
18 Years to 50 Years (Adult) |
NCT00886873 |
Mife_Fibroids_02 |
Mifemyo_2 |
May 2008 |
April 2009 |
May 2009 |
April 23, 2009 |
October 17, 2014 |
|
- Hospital Eusebio Hernandez
Ciudad Habana, La Habana, Cuba
|
| 27 |
NCT02283502 |
Unknown † |
Clinical Test of the MRgHIFU System on Uterine Fibroids |
|
|
Interventional |
Phase 1 |
- Chin-Jung Wang
- National Health Research Institutes, Taiwan
- Chang Gung Memorial Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Check Adverse Event or Serious Adverse Event
- Using MRI to confirm the volume of the fibromyoma.
- Using quality of life questionnaire to compare quality of life that before and after treatment
|
20 |
Female |
35 Years to 45 Years (Adult) |
NCT02283502 |
NHRI-CTC-067 |
MRgHIFU |
September 2014 |
May 2015 |
May 2015 |
November 5, 2014 |
November 5, 2014 |
|
- Clinical Trial Center
Taoyuan, Taiwan
|
| 28 |
NCT03400826 |
Not yet recruiting |
Effects of Simvastatin on Uterine Leiomyoma Size |
- Fibroid Uterus
- Fibroid Tumor
- Leiomyoma
- (and 2 more...)
|
- Drug: Simvastatin 40mg
- Drug: Placebo 40 mg
|
Interventional |
Phase 2 |
- Johns Hopkins University
- National Institutes of Health (NIH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Change in Tumor size volume pre and post study intervention
- Clinical symptom improvement as determined by the Uterine Fibroid Symptom and Health Related Quality of Life Questionnaire.
- Adherence to the recommended treatment dosing
- Subject retention
|
60 |
Female |
18 Years to 55 Years (Adult) |
NCT03400826 |
IRB00149869 |
|
April 1, 2018 |
January 1, 2024 |
December 1, 2024 |
January 17, 2018 |
March 12, 2018 |
|
- Johns Hopkins Hospital
Baltimore, Maryland, United States
|
| 29 |
NCT01311869 |
Terminated |
Green Tea Extract: a Non-Surgical Alternative for Treatment of Uterine Fibroids |
|
- Dietary Supplement: EGCG ( Green Tea extract)
- Dietary Supplement: Brown rice pills
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Health Services Research
|
- fibroid size
- Quality of life
|
43 |
Female |
18 Years and older (Adult, Senior) |
NCT01311869 |
Green Tea Study |
|
December 2010 |
September 2011 |
September 2011 |
March 10, 2011 |
October 24, 2013 |
|
- Meharry Medical College
Nashville, Tennessee, United States
|
| 30 |
NCT02925494 |
Active, not recruiting |
An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids |
- Uterine Fibroids
- Heavy Menstrual Bleeding
|
- Drug: Estradiol/Norethindrone Acetate
- Drug: Elagolix
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage of Responders based on menstrual blood loss volume reduction
- Change in Menstrual Blood Loss (MBL) Volume
- Percentage of participants with increase in Hemoglobin
- (and 2 more...)
|
400 |
Female |
18 Years to 51 Years (Adult) |
NCT02925494 |
M12-816 |
|
September 14, 2016 |
October 26, 2018 |
March 29, 2019 |
October 6, 2016 |
January 23, 2018 |
|
- Alabama Clinical Therapeutics
Birmingham, Alabama, United States - Choice Research, LLC
Dothan, Alabama, United States - Brown, Pearson, Guepet Gynecol
Fairhope, Alabama, United States - (and 119 more...)
|
| 31 |
NCT01393704 |
Completed
Has Results |
Vasopressin Administration During Laparoscopic Myomectomy: a Randomized Controlled Trial |
|
|
Interventional |
Phase 4 |
- Brigham and Women's Hospital
- Beth Israel Deaconess Medical Center
- North Shore Medical Center
- Cedars-Sinai Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Estimating Blood Loss at the End of Myomectomy - Hematocrit Percentage
- Estimating Blood Loss at the End of Myomectomy - Surgeon Estimated Blood Loss
- Estimating Blood Loss at the End of Myomectomy - Suction Canister Estimated Blood Loss Calculation
- (and 2 more...)
|
152 |
Female |
18 Years to 60 Years (Adult) |
NCT01393704 |
2011-P-000264/1 |
|
July 2011 |
April 2015 |
June 2015 |
July 13, 2011 |
February 15, 2018 |
April 10, 2017 |
- Brigham&Women's hospital
Boston, Massachusetts, United States
|
| 32 |
NCT03328260 |
Recruiting |
High Intensity Focused Ultrasound in Uterine Myoma |
|
|
Interventional |
Not Applicable |
- Seoul National University Hospital
- ALPINION Medical Systems
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
34 |
Female |
19 Years and older (Adult, Senior) |
NCT03328260 |
APM-05 |
|
December 12, 2017 |
October 2018 |
October 2018 |
November 1, 2017 |
March 9, 2018 |
|
- Seoul National University Bundang Hospital
Seongnam Si, Gyenggi DO, Korea, Republic of
|
| 33 |
NCT01834703 |
Terminated |
Uterine Artery Embolization(UAE) Versus High-Intensity-Focused-Ultrasound(HIFU) for Treatment of Uterine Fibroids |
|
- Procedure: UAE
- Procedure: HIFU
|
Interventional |
Not Applicable |
- Chinese University of Hong Kong
- Prince of Wales Hospital, Shatin, Hong Kong
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Treatment success rate
- clinical evidence of symptom recurrence
- Incidence of procedure related complication
- (and 4 more...)
|
85 |
Female |
30 Years to 47 Years (Adult) |
NCT01834703 |
VIR-13-02 |
|
May 2009 |
December 2015 |
December 2015 |
April 18, 2013 |
August 22, 2017 |
|
- Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong, Hong Kong - Department of Obstectrics and Gynaecology, Prince of Wales Hospital
Hong Kong, Hong Kong
|
| 34 |
NCT01936493 |
Completed |
Biologic Predictors of Leiomyoma Treatment Outcomes |
- Uterine Leiomyomas
- Fibroids
- Uterine Fibroids
- Myomas
|
- Genetic: DNA analysis
- Other: Hormonal analysis
|
Observational |
|
- Elizabeth A. Stewart
- Mayo Clinic
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Analyze environmental exposures and genetic predisposition among women exhibiting disease manifestations of uterine fibroids.
|
38 |
Female |
18 Years to 99 Years (Adult, Senior) |
NCT01936493 |
09-003657 |
|
August 2009 |
May 2015 |
May 26, 2015 |
September 6, 2013 |
March 27, 2017 |
|
- Mayo Clinic
Rochester, Minnesota, United States
|
| 35 |
NCT01483417 |
Unknown † |
Single Incision Laparoscopic Surgery (SILS) Versus Conventional Laparoscopic Hysterectomy |
- Uterine Myoma
- Uterine Adenomyosis
|
- Procedure: Single incision Laparoscopic hysterectomy
- Procedure: Conventional laparoscopic hysterectomy
|
Interventional |
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Conversion rate
- Patient and Observer Scar Assessment Scale (POSAS)
- Postoperative pain
|
240 |
Female |
20 Years to 60 Years (Adult) |
NCT01483417 |
2011-10-004 |
|
December 2011 |
December 2012 |
March 2013 |
December 1, 2011 |
February 22, 2012 |
|
- Keimyung University Dongsan Hospital
Deagu, Korea, Republic of - Catholic Incheon Hospital
Incheon, Korea, Republic of - Samsung Medical Center
Seoul, Korea, Republic of - (and 5 more...)
|
| 36 |
NCT03103087 |
Recruiting |
LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids |
- Heavy Menstrual Bleeding
- Uterine Fibroid
|
- Drug: Relugolix
- Drug: Low-dose Hormonal Add-back
- Drug: Relugolix Placebo
- Drug: Low-dose Hormonal Add-back Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Menstrual blood loss volume Group A vs Group C
- Menstrual blood loss volume Group B vs Group C
|
390 |
Female |
18 Years to 50 Years (Adult) |
NCT03103087 |
MVT-601-3002 |
|
March 28, 2017 |
December 2018 |
June 2019 |
April 6, 2017 |
February 26, 2018 |
|
- Birmingham
Birmingham, Alabama, United States - Mesa
Mesa, Arizona, United States - Tuscon
Tucson, Arizona, United States - (and 85 more...)
|
| 37 |
NCT01750008 |
Active, not recruiting |
Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions |
|
- Procedure: Global Fibroid Ablation
- Procedure: Myomectomy
|
Interventional |
Not Applicable |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Compare the mean time of hospitalization following laparoscopic treatment of fibroids by myomectomy or GFA
- Compare and contrast post-treatment readmission and reintervention rate
- Compare and Contrast peri and post procedural safety including procedural blood loss and complications
- (and 5 more...)
|
50 |
Female |
18 Years to 55 Years (Adult) |
NCT01750008 |
CP-00-0018 |
LUSTOR |
November 2012 |
September 2013 |
September 2018 |
December 17, 2012 |
July 2, 2017 |
|
- Tubingen University Hospital
Tubingen, Germany
|
| 38 |
NCT03049735 |
Recruiting |
LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids |
- Heavy Menstrual Bleeding
- Uterine Fibroid
|
- Drug: Relugolix
- Drug: Low-dose Hormonal Add-back
- Drug: Relugolix Placebo
- Drug: Low-dose Hormonal Add-back Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Menstrual blood loss volume Group A vs Group C
- Menstrual blood loss volume Group B vs Group C
|
390 |
Female |
18 Years to 50 Years (Adult) |
NCT03049735 |
MVT-601-3001 |
|
January 2017 |
December 2018 |
June 2019 |
February 10, 2017 |
February 26, 2018 |
|
- Andaluisa
Andalusia, Alabama, United States - Mobile
Mobile, Alabama, United States - Little Rock
Little Rock, Arkansas, United States - (and 61 more...)
|
| 39 |
NCT00277680 |
Unknown † |
Laparoscopic Occlusion of Uterine Vessels Compared to Uterine Fibroid Embolization for Treatment of Uterine Fibroids |
|
- Procedure: Laparoscopic bilateral occlusion of uterine artery
- Procedure: Radiological embolization (UFE)
|
Interventional |
Not Applicable |
- Ullevaal University Hospital
- Oslo University Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Reduction of menstrual bleeding six months after treatment measured by PBAC
- Patient assessment of symptom reduction including menorrhagia and bulk symptoms
- postoperative pain
- (and 6 more...)
|
60 |
Female |
30 Years and older (Adult, Senior) |
NCT00277680 |
MU22200105 |
|
December 2000 |
|
April 2010 |
January 16, 2006 |
July 6, 2011 |
|
- Ullevål University Hospital
Oslo, Norway
|
| 40 |
NCT02209545 |
Recruiting |
Misoprostol for Reduction of Blood Loss During Fibroid Surgery |
|
- Drug: Misoprostol
- Drug: Placebo
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Estimated intra-operative blood loss
- Duration of procedure
- Length of inpatient hospitalization
- Post-operative blood transfusion
|
50 |
Female |
18 Years to 50 Years (Adult) |
NCT02209545 |
STU00091259 |
|
October 2014 |
May 2019 |
May 2020 |
August 6, 2014 |
September 6, 2017 |
|
- Northwestern University, Prentice Women's Hospital
Chicago, Illinois, United States
|
| 41 |
NCT03421639 |
Recruiting |
Aromatase Plus GnRH Analogue Versus Ulippristal Acetate in Uterine Fibroids |
- Uterine Fibroid
- Uterine Bleeding
|
- Drug: Ulipristal acetate
- Drug: Aromatase inhibitor plus GnRH analog
|
Interventional |
Phase 4 |
- Centre for Endocrinology and Reproductive Medicine, Italy
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- uterine volume (measured by ultrasound) decrease
- uterine bleeding (numbere of episodes)
|
150 |
Female |
30 Years to 45 Years (Adult) |
NCT03421639 |
CR-01-18 |
|
December 1, 2017 |
January 31, 2019 |
February 1, 2020 |
February 5, 2018 |
February 7, 2018 |
|
|
| 42 |
NCT02288130 |
Recruiting |
Ulipristal vs. GnRHa Prior to Laparoscopic Myomectomy |
|
- Drug: GnRHa
- Drug: Ulipristal
|
Interventional |
Phase 4 |
- VU University Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Blood loss during surgery
|
100 |
Female |
18 Years and older (Adult, Senior) |
NCT02288130 |
2014.421 |
MYOMEX |
December 2014 |
July 2017 |
November 2017 |
November 11, 2014 |
November 3, 2016 |
|
- Flevoziekenhuis
Almere, Netherlands - Onze Lieve Vrouwen Gasthuis
Amsterdam, Netherlands - Sint Lucas Andreas Ziekenhuis
Amsterdam, Netherlands - (and 6 more...)
|
| 43 |
NCT00332033 |
Completed |
Development of a Non-Invasive Treatment for Uterine Leiomyoma (Fibroids) |
- Uterine Leiomyoma
- Fibroids
|
|
Interventional |
Phase 2 |
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Primary Purpose: Treatment
|
|
32 |
Female |
35 Years to 50 Years (Adult) |
NCT00332033 |
060029
06-CH-0029 |
|
May 25, 2006 |
|
February 16, 2007 |
June 1, 2006 |
July 2, 2017 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 44 |
NCT03500367 |
Recruiting
New |
Efficacy and Safety of Rapamycin (Sirolimus) in the Treatment of Symptomatic Uterine Fibroids and Leiomyomatosis |
|
|
Interventional |
Phase 4 |
- Peking Union Medical College Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- size of uterus and the myoma
- hormone levels
- menstrual blood volume / haemorrhage
- (and 2 more...)
|
25 |
Female |
18 Years to 50 Years (Adult) |
NCT03500367 |
LPMS201802 |
|
January 1, 2018 |
June 30, 2022 |
December 31, 2022 |
April 17, 2018 |
April 17, 2018 |
|
- Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
Beijing, China/Beiing, China
|
| 45 |
NCT01715597 |
Completed |
Study on the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women With Uterine Myoma |
|
- Drug: ascorbic acid
- Drug: Normal saline
|
Interventional |
Phase 3 |
- Seoul National University Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
|
50 |
Female |
Child, Adult, Senior |
NCT01715597 |
SNUBH_GO_016 |
|
December 2012 |
October 2017 |
October 2017 |
October 29, 2012 |
October 31, 2017 |
|
- Seoul National University Bundang Hospital
Gyeongg-ido, Korea, Republic of
|
| 46 |
NCT00743080 |
Completed |
Randomized Controlled Trial (RCT)Comparing GYNAECARE MORCELLEX Versus ROTOCUT GI Tissue Morcellators |
|
- Procedure: Laparoscopic myomectomy and supracervical hysterectomy with GYNECARE MORCELLEX
- Procedure: Laparoscopic myomectomy and supracervical hysterectomy with ROTOCUT G1
|
Interventional |
Phase 4 |
- University Magna Graecia
- Johnson & Johnson
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Morcellament time
- Total operative time
- Feasibility [subjective score of difficulty]
- (and 5 more...)
|
|
Female |
18 Years to 80 Years (Adult, Senior) |
NCT00743080 |
300-07-015 |
|
January 2008 |
|
January 2010 |
August 28, 2008 |
November 3, 2010 |
|
- University Magna Graecia
Catanzaro, Italy
|
| 47 |
NCT00740831 |
Completed
Has Results |
PGL4001 Versus GnRH-agonist in Uterine Myomas |
|
- Drug: PGL4001
- Drug: leuprorelin
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit (Week 13 Visit)
- Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist
- Co-primary Safety Endpoint: % of Subjects Reporting Moderate or Severe Hot Flushes as Adverse Events Throughout the Treatment Period for PGL4001 Compared With GnRH-agonist
- Change in the Total Volume of the Three Largest Myomas From Baseline to Week 13
|
301 |
Female |
18 Years to 50 Years (Adult) |
NCT00740831 |
PGL07-022 |
PEARLII |
August 2008 |
January 2010 |
June 2010 |
August 25, 2008 |
December 17, 2012 |
November 16, 2012 |
- Medical University Graz
Graz, Austria - Medical University of Innsbruck
Innsbruck, Austria - Landesklinikum Thermenregion Neunkirchen; Dept. For Gynecology
Neunkirchen, Austria - (and 43 more...)
|
| 48 |
NCT01861015 |
Completed |
Vasopressin Versus Epinephrine in Myomectomy |
|
- Drug: Epinephrine
- Drug: Vasopressin
|
Interventional |
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
|
60 |
Female |
18 Years to 75 Years (Adult, Senior) |
NCT01861015 |
KNC13-013 |
|
May 2013 |
March 2014 |
March 2014 |
May 23, 2013 |
January 22, 2016 |
|
- CHA Gangnam Medical Center
Seoul, Korea, Republic of
|
| 49 |
NCT00323999 |
Unknown † |
Hysteroscopic Monopolar and Bipolar Resection |
|
- Procedure: Hysteroscopic resection of fibroids, polyps and endometrium.
|
Interventional |
Not Applicable |
- Ullevaal University Hospital
|
Other |
|
|
|
Female |
18 Years to 60 Years (Adult) |
NCT00323999 |
AB170262 |
|
December 2004 |
|
December 2007 |
May 10, 2006 |
May 10, 2006 |
|
- Gynaecological department Ullevaal University Hospital
Oslo, Norway
|
| 50 |
NCT03323905 |
Recruiting |
Single Arm Study Using the Symphony -- MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas |
|
- Device: Symphony MRI guided High Intensity Focused Ultrasound (HIFU)
|
Interventional |
Not Applicable |
- Sunnybrook Health Sciences Centre
- Sunnybrook Research Institute
- Harmonics Medical Inc.
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The ability to ablate fibroid tissue
- Treatment effectiveness to reduce fibroid size.
- Incidence of treatment-emerging AEs (safety)
- Confirmation of intended fibroid treatment
|
50 |
Female |
18 Years to 60 Years (Adult) |
NCT03323905 |
HIFUSB |
HIFUSB |
November 16, 2017 |
September 2020 |
September 2022 |
October 27, 2017 |
April 26, 2018 |
|
- Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
|
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