Clinical trials: Leiomyomas
Laparoscopy, Tissue Adhesion, Surgery-Induced
The Efficacy and Safety of Medicurtain® in Patients With Total Laparoscopic Hysterectomy (Pivotal Study)
This study was designed to assess the safety and efficacy of MEDICURTAIN. Patients who underwent total laparoscopic hysterectomy were randomly assigned either into Medicurtain® treatment group or non-treatment control group.
- Conditions
- Laparoscopy, Tissue Adhesion, Surgery-Induced, Leiomyoma of the Uterine Body
- Trial name
- NCT04672421
- Testing
- Medicurtain®
- Where
- South Korea
- Volunteers
- 107 people
- Sponsor
- Shin Poong Pharmaceutical Co. Ltd.
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
Leiomyoma, Leiomyosarcoma
Development of a Predictive Model for Early Differential Diagnosis of Uterine Leiomyomas and Leiomyosarcomas
The development of an accurate and non-invasive diagnostic method is a priority in areas such as gynecology and oncology, specifically to improve the health of those patients with surgical indication for diagnosis of myometrial…
- Trial name
- MYOSARC (NCT04214457)
- Testing
- Biopsy and peripheral blood collection
- Where
- 4 sites in Spain
- Volunteers
- 1,000 people
- Sponsor
- Igenomix
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
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, 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 (Replicate Study)
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
- NCT02691494
- Testing
- Elagolix, Estradiol/Norethindrone Acetate
- Where
- 105 sites in United States, Canada
- Volunteers
- 378 people
- Sponsor
- AbbVie
Uterine Fibroids, Heavy Menstrual Bleeding
An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
This is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate the long-term efficacy and safety of…
- Trial name
- NCT02925494
- Testing
- Estradiol/Norethindrone Acetate, Elagolix
- Where
- 124 sites in United States, Canada and 1 more
- Volunteers
- 433 people
- Sponsor
- AbbVie
Uterine Fibroids, Heavy Menstrual Bleeding
Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
The primary objective of this study is to demonstrate the superior efficacy versus placebo of OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids…
- Trial name
- PRIMROSE 1 (NCT03070899)
- Testing
- OBE2109, Add-back
- Where
- 116 sites in United States
- Volunteers
- 526 people
- Sponsor
- ObsEva SA
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, Heavy Menstrual Bleeding
Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
The primary objective of this study is to demonstrate the superior efficacy versus placebo of OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids…
- Trial name
- PRIMROSE 2 (NCT03070951)
- Testing
- OBE2109, Add-back
- Where
- 96 sites in United States, Bulgaria and 7 more
- Volunteers
- 511 people
- Sponsor
- ObsEva SA
Leiomyoma
Mode of Action Study of Vilaprisan and Ulipristal Acetate in Patients With Uterine Fibroids for Whom Surgery is Planned
To investigate the clinical effects of vilaprisan and ulipristal acetate at molecular and cellular level on uterine and fibroid tissue taken from patients (after surgery / biopsy)
- Trial name
- NCT03342859
- Testing
- Vilaprisan, BAY1002670, Ulipristal
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Bayer
Castration-resistant Prostate Cancer, Metastatic Breast Cancer
Phase I Study of LFA102 in Patients With Prolactin Receptor-positive Castration-resistant Prostate Cancer or Prolactin Receptor-positive Metastatic Breast Cancer
The purpose of this first multi-dose study in cancer patients is to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D), characterize the safety, tolerability and pharmacokinetics profile.
- Conditions
- Castration-resistant Prostate Cancer, Metastatic Breast Cancer, Uterine Leiomyoma
- Trial name
- NCT01338831
- Testing
- LFA102
- Where
- 9 sites in United States, Belgium and 2 more
- Volunteers
- 73 people
- Sponsor
- Novartis Pharmaceuticals
Uterine Fibroid, Endometriosis
Bone Mineral Density in Women With Uterine Fibroids or Endometriosis
The purpose of this study is to characterize the longitudinal bone mineral density (BMD) in premenopausal women with uterine fibroids or endometriosis.
- Trial name
- NCT03744507
- Where
- 63 sites in United States, Australia and 5 more
- Volunteers
- 660 people
- Sponsor
- Myovant Sciences GmbH
Uterine Fibroids
A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Patients in Canada
This is a non-interventional, cross-sectional survey study to evaluate the effectiveness of the Additional Risk Minimization Measures for Fibristal among Patients in Canada.
- Trial name
- NCT04567095
- Where
- United States
- Sponsor
- Allergan
Uterine Fibroids
A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada
This is a non-interventional, cross-sectional survey study to evaluate the effectiveness of the Additional Risk Minimization Measures for Fibristal among Healthcare Professionals (HCPs).
- Trial name
- NCT04567589
- Where
- United States
- Sponsor
- Allergan
Uterine Leiomyoma
Uterine Artery Embolization With Microspheres in Patients With Leiomyoma.
To evaluate the therapeutic response to uterine artery embolization in 30 patients with leiomyoma using the microspheres Embosoft (Embosoft® - Scitech Medical).
- Trial name
- EMBOSOFT I (NCT03535610)
- Testing
- Uterine Embolization
- Where
- Brazil
- Volunteers
- 32 people
- Sponsor
- Scitech Produtos Medicos SA
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, 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
Leiomyoma
A Multicenter Prospective Non-Interventional Study Assessing the Management of Canadian Women With Uterine Fibroids
This study will characterize the treatments and outcomes associated with different uterine fibroid treatments in Canada, to understand patients' preferences and satisfaction with different medical and procedural interventions.
- Trial name
- NCT02580578
- Testing
- No Intervention
- Where
- 20 sites in Canada
- Volunteers
- 1,500 people
- Sponsor
- Allergan
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