Clinical trials: Uterine Leiomyomas
Uterine Fibroids
Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
The primary objective of this study is to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo.The secondary objectives of this study are to…
- Trial name
- ASTEROID 7 (NCT03699176)
- Testing
- Vilaprisan (BAY1002670)
- Where
- 8 sites in Japan
- Sponsor
- Bayer
Uterine Fibroids, Bleeding
Study to Evaluate the Safety and Effectiveness of MRgFUS Compared With Myomectomy for the Treatment of Uterine Fibroids
The objective of this trial is to evaluate the safety and efficacy of ExAblate for the treatment of uterine fibroids. Women, seeking treatment for symptomatic uterine leiomyomata will be eligible for the study.Women who agree to…
- Conditions
- Uterine Fibroids, Bleeding, Pelvic Pain
- Trial name
- NCT01328067
- Testing
- Exablate 2100, Myomectomy
- Where
- United Kingdom
- Sponsor
- InSightec
Uterine Fibroids
An Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
To determine the safety of extended treatment with Proellex® in women who have successfully completed either study ZPV-201 [NCT02323646] or ZPU-203 [NCT02301897] and meet eligibility criteria.
- Trial name
- NCT02811159
- Testing
- Telapristone acetate
- Where
- 8 sites in United States
- Volunteers
- 20 people
- Sponsor
- Repros Therapeutics 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
Uterine Fibroids
MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids
This is a prospective, nonrandomized, multi-center study to evaluate the safety and effectiveness of ExAblate in the treatment of uterine fibroids.
- Trial name
- NCT00166270
- Testing
- ExAblate 2000
- Where
- 6 sites in United States
- Volunteers
- 70 people
- Sponsor
- InSightec
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
Uterine Fibroids and Heavy Menstrual Bleeding
A Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding
To evaluate the safety and efficacy of vilaprisan in Japanese subjects with uterine fibroids and heavy menstrual bleeding (HMB).
- Trial name
- ASTEROID 8 (NCT03476928)
- Testing
- Vilaprisan (BAY1002670)
- Where
- 25 sites in Japan
- Volunteers
- 153 people
- Sponsor
- Bayer
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.
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
Uterine Fibroids, Leiomyoma
An Open-Label Study to Evaluate the Effect of Elix Cycle Balance & Elix Daily Harmony on Fibroid-related Symptoms
This is a 24-week, single-arm, open-label, virtual study evaluating the effects of Elix Cycle Balance and Elix Daily Harmony on uterine fibroid-related symptoms and quality of life in 42 participants.
- Conditions
- Uterine Fibroids, Leiomyoma, Menstrual Pain
- Trial name
- NCT07078682
- Testing
- Elix Daily Harmony
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Zenchi, Inc.
Uterine Fibroids
A Pharmacodynamic Study of Leuprorelin Gelatin-Free Formulation in Female Subjects With Uterine Fibroids.
The purpose of this study is to determine the pharmacodynamics of leuprorelin gelatin free formulation (GF) to leuprorelin gelatin containing formulation (GC) in female subjects with uterine fibroids.
- Trial name
- NCT00776074
- Testing
- Leuprorelin (GF), Leuprorelin (GC)
- Volunteers
- 80 people
- Sponsor
- Takeda
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.
Uterine Fibroid
Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)
This is a prospective, multicenter, observational, post-market clinical follow-up study in subjects treated with Bearing nsPVA Embolization Particles for uterine fibroid embolization.
- Trial name
- BETTER-UAE (NCT06153667)
- Testing
- Bearing nsPVA
- Where
- 4 sites in United States, Australia and 1 more
- Volunteers
- 100 people
- Sponsor
- Merit Medical Systems, Inc.
Uterine Fibroids
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
This is a phase III, multicentre, long-term open-label extension of the phase III study: Pearl IIIextension (PGL09-027). During Pearl III (PGL09-026) and subsequent Pearl III extension (PGL09-027), patients have been exposed to a…
- Trial name
- PEARLext2 (NCT01642472)
- Testing
- Ulipristal Acetate - open label
- Where
- 16 sites in Austria, Belgium and 2 more
- Volunteers
- 64 people
- Sponsor
- PregLem SA
Uterine Fibroids, Polyps
Comparative Sedation Study of the MyoSure Hysteroscopic Tissue Removal System
The purpose of this study is to develop a recommended local anesthetic protocol and post-treatment pain management regimen, in order to assure patient comfort during office-based treatment with the MyoSure Hysteroscopic Tissue…
- Trial name
- NCT00979342
- Testing
- Hysteroscopic Morcellator
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Hologic, Inc.
Pregnancy Related, Pregnancy Complications
Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring
The Relugolix Pregnancy Registry is a prospective, observational cohort study designed to evaluate the association between relugolix-containing therapy exposure during pregnancy and subsequent maternal, fetal, and infant…
- Conditions
- Pregnancy Related, Pregnancy Complications, Pregnancy, High Risk
- Trial name
- NCT05739123
- Testing
- Relugolix-Containing Product
- Where
- United States
- Volunteers
- 728 people
- Sponsor
- Sumitomo Pharma Switzerland GmbH
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.
Gynecologic Disease, Gynecologic Cancer
Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology
GynRAN is an international, multicentre, transversal, diagnostic and non-interventional study carried out in gynecology-obstetrics/gynecological oncology departments that aims to identify a diagnostic signature for gynecological…
- Conditions
- Gynecologic Disease, Gynecologic Cancer, Endometriosis, Ovarian Cancer
- Trial name
- GynRNA (NCT06392997)
- Testing
- Saliva sample
- Where
- 13 sites in France
- Volunteers
- 2,500 people, healthy volunteers welcome
- Sponsor
- ZIWIG