Clinical trials: Uterine Leiomyomata
Heavy Uterine Bleeding, Uterine Fibroids
Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bleeding in premenopausal women…
- Trial name
- NCT01817530
- Testing
- Elagolix, 0.5 mg estradiol / 0.1 mg norethindrone acetate, 1 mg estradiol / 0.5 mg norethindrone acetate
- Volunteers
- 571 people
- Sponsor
- AbbVie
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
Leiomyoma, Uterine Fibroids
Fibroid Ablation Study - Large Fibroids
The purpose of this study is to establish the effectiveness and confirm the safety of the VizAblate System in the ablation of large (> 5 cm) symptomatic uterine fibroids.
- Conditions
- Leiomyoma, Uterine Fibroids, Menorrhagia
- Trial name
- FAST-L (NCT01539187)
- Testing
- VizAblate System
- Where
- 10 sites in Mexico, Netherlands and 1 more
- Volunteers
- 6 people
- Sponsor
- Gynesonics
Uterine Fibroids
China Clinical Trial for Therapeutic MR-HIFU Ablation of Uterine Fibroids
The purpose of this study is to demonstrate safety and effectiveness of the Philips Sonalleve Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) for treatment of uterine fibroids in a Chinese population.
- Trial name
- NCT01588899
- Testing
- MR-HIFU uterine fibroid treatment
- Where
- 2 sites in China
- Volunteers
- 107 people
- Sponsor
- Philips Healthcare
Uterine Fibroids
A Prospective Multicenter Non-interventional Study of Women Treated With ESMYA (Ulipristal Acetate) as Pre-operative Treatment of Moderate to Severe Symptoms of Uterine Fibroids
This is a multi-center, prospective, non-interventional study of patients who have been diagnosed with moderate to severe symptoms of uterine fibroids and are initiating a pre-operative treatment with ESMYA.
- Trial name
- PREMYA (NCT01635452)
- Where
- 75 sites in Austria, France and 8 more
- Volunteers
- 1,500 people
- Sponsor
- PregLem SA
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.
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
Uterine Fibroids
Non-interventional Study to Evaluate Long Term Safety, Prescription Management Patterns of Esmya in a Long Term Setting
This is a multi-centre, multinational, prospective, non-interventional study in females with a diagnosis of moderate to severe uterine fibroids, and for whom a treatment with Esmya in a long term manner is planned, and in…
- Trial name
- Premium (NCT02748460)
- Where
- 115 sites in Belgium, Czechia and 14 more
- Volunteers
- 1,527 people
- Sponsor
- PregLem SA
Leiomyoma
A Long-Term Safety Study of Asoprisnil in the Treatment of Uterine Fibroids.
This study was designed to determine the long-term safety of asoprisnil 10 mg in women with one or more uterine fibroids after an initial 12 weeks in study M99-144.
- Trial name
- NCT00156182
- Testing
- Asoprisnil
- Volunteers
- 38 people
- Sponsor
- Abbott
Menorrhagia, Uterine Fibroids
Uterine Artery Occlusion for Fibroid Related Bleeding
The primary objective of this study is to evaluate the safety and effectiveness of Doppler guided Uterine Artery Occlusion (D-UAO) as treatment for the reduction of fibroid-associated symptoms.
- Trial name
- NCT00496067
- Testing
- Doppler-Guided Uterine Artery Occlusion Device
- Where
- 14 sites in Denmark, France and 5 more
- Volunteers
- 91 people
- Sponsor
- Ethicon, Inc.
Uterine Fibroids
Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids
The purpose of this clinical study is to determine whether treatment with the Philips Sonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU) system is effective in the treatment symptomatic uterine…
- Trial name
- SOFIA (NCT01504308)
- Testing
- MR-HIFU treatment
- Where
- 9 sites in United States, Canada and 1 more
- Volunteers
- 49 people
- Sponsor
- Philips Healthcare
Myoma of Uterus
Clinical Trial to Evaluate the Efficacy and Safety of DW4902
A Multi-center, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of DW4902 in Patients with Uterine Fibroids.
- Trial name
- NCT07319520
- Testing
- DW4902 160mg, DW4902 240mg, DW4902 320mg
- Where
- South Korea
- Volunteers
- 71 people
- Sponsor
- Daewon Pharmaceutical Co., Ltd.
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
Post Market Evaluation of Acessa With TAG
The purpose of this study is to test both user preference and speed of targeting with the use of the Acessa System with Targeting Animation Guidance (TAG).
- Trial name
- TAG (NCT01842789)
- Testing
- Acessa Procedure
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Acessa Health, Inc.
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.
Leiomyoma, Uterine, Leiomyosarcoma Uterus
Accuracy of the Preoperative Molecular Diagnosis of Uterine Tumors by Liquid Biopsy
The development of precise and non-invasive diagnostic methods is a priority in areas such as gynaecology and oncology, and above all in improving the health of those patients with a surgical indication for hysterectomy…
- Trial name
- MYOSARCII (NCT04935333)
- Testing
- Collection of Leiomyoma samples, Collection of Leiomyosarcoma samples, Collection of control samples
- Where
- 21 sites in Spain
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Igenomix
Uterine Fibroids With Menorrhagia
Phase II Study of CMS-D002 Capsule for Uterine Fibroids With Menorrhagia
Objective This study evaluates whether CMS-D002 capsules are effective in treating menorrhagia in participants with uterine fibroids associated with menorrhagia.
- Trial name
- NCT07402369
- Testing
- CMS-D002 Capsules 10 mg, CMS-D002 Capsules 25 mg, CMS-D002 Capsules 50 mg
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Shenzhen Kangzhe Biotechnology Co., Ltd.
Leiomyoma
Assess Safety and Efficacy of Vilaprisan in Patients With Uterine Fibroids
The study is performed to assess the efficacy of Vilaprisan (BAY1002670) in patients with uterine fibroids compared to placebo and ulipristal.
- Trial name
- ASTEROID 2 (NCT02465814)
- Testing
- Vilaprisan (BAY1002670), Vilaprisan (BAY1002670, Ulipristal
- Where
- 64 sites in Austria, Belgium and 14 more
- Volunteers
- 120 people
- Sponsor
- Bayer
Uterine Leiomyomas
Therapeutic MRI Guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids
This study is to collect supplementary safety and technical effectiveness data of Philips MRI guided High Intensity Focused Ultrasound (HIFU) in ablating uterine tissue associated with symptomatic fibroids in a 3T MRI scanner.
- Trial name
- HIFU (NCT01141062)
- Testing
- Philips MR-guided HIFU
- Where
- 2 sites in Canada
- Volunteers
- 15 people
- Sponsor
- Philips Healthcare
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