Clinical trials: Uterine Fibroids
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.
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.
Fertility Issues
Home Examinations Researching and Understanding Submucosal Evaluations
To demonstrate that imaging via home ultrasound can identify submucosal fibroids. The image quality and submucosal fibroid detection specificity of the home imaging has already been demonstrated; the aim of this study is to…
- Trial name
- HER-USE (NCT05004870)
- Testing
- Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine)
- Where
- United States
- Sponsor
- Turtle Health, Inc.
Menorrhagia, Uterine Fibroids
Doppler-Guided Uterine Artery Occlusion (DUAO) Device for Fibroid Related Bleeding
The objective of this study is to evaluate the safety and effectiveness of Doppler guided uterine artery occlusion (D-UAO) for the reduction of fibroid associated bleeding.
- Trial name
- DUAO (NCT00496080)
- Testing
- Doppler-Guided Uterine Artery Occlusion Device (DUAO)
- Where
- 11 sites in United States, Canada and 1 more
- Volunteers
- 87 people
- Sponsor
- Ethicon, Inc.
Uterine Fibroids
Evaluating the Safety and Efficacy of Proellex® (CDB-4124) 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
- NCT00735553
- Testing
- Proellex
- Where
- 15 sites in United States
- Volunteers
- 77 people
- Sponsor
- Repros Therapeutics Inc.
Uterine Fibroids, Polyps
HOME Study: Hysteroscopic Office Myomectomy Evaluation
The purpose of this study is to demonstrate safety and effectiveness of the MyoSure Tissue Removal System when used by community gynecologists in an office setting for the treatment of patients with symptomatic intrauterine…
- Trial name
- HOME (NCT01152112)
- Testing
- Myomectomy
- Where
- 9 sites in United States
- Volunteers
- 74 people
- Sponsor
- Hologic, Inc.
Leiomyomas
Somatic Stem Cells in Leiomyomas?
The purpose of this study is to identify and characterize the Somatic Stem Cell (SSC) responsible for the formation and growth of leiomyomas using the Side Population method.
- Trial name
- NCT01592903
- Testing
- Laparoscopic myomectomy. Following analysis and proliferation of cells isolated from removed human leiomyoma.
- Where
- Spain
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Igenomix
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
Fibroid Uterus, Leiomyoma
Safety of Treatment of Uterine Fibroids With Asoprisnil
The objective of this study is to determine the long-term safety of asoprisnil in women with symptomatic uterine fibroids who completed the 6 month Study C02-037.
- Conditions
- Fibroid Uterus, Leiomyoma, Menorrhagia, Metrorrhagia
- Trial name
- NCT00156208
- Testing
- Asoprisnil
- Volunteers
- 166 people
- Sponsor
- Abbott
Uterine Fibroids
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study)
This is the long-term extension of a phase III, efficacy and safety open-label (protocol PGL09-026) with PGL4001 10mg tablets once daily for three months, blinded towards the administration of progestin or placebo tablets after…
- Trial name
- NCT01252069
- Testing
- PGL4001, progestin, drug free period
- Where
- 18 sites in Austria, Belgium and 2 more
- Volunteers
- 132 people
- Sponsor
- PregLem SA
Uterine Fibroids
Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids
Safety and efficacy study of 25 and 50 mg doses of Proellex
- Trial name
- NCT01069120
- Testing
- Proellex
- Where
- 4 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
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
Uterine Fibroids
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)
The primary objective of this study was to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo.
- Trial name
- NCT03400943
- Testing
- Vilaprisan (BAY1002670)
- Where
- 103 sites in United States, Bulgaria and 7 more
- Volunteers
- 93 people
- Sponsor
- Bayer
Heavy Menstrual Bleeding, Uterine Fibroids
A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules
Uterine Fibroids (UF) are noncancerous (benign) tumors that commonly occur in up to 80% of women of reproductive age. Symptoms can include heavy menstrual bleeding (HMB), low back pain, urinary frequency and urgency…
- Trial name
- REACH (NCT05026502)
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- AbbVie
Uterine Leiomyomata (Fibroids)
Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 Administered to Healthy Japanese Females
The primary purpose of this study is to assess the safety and tolerability of ascending single oral doses of PRA-027 in healthy Japanese females.
- Trial name
- NCT00444704
- Testing
- PRA-027
- Where
- Japan
- Volunteers
- healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Uterine Fibroid
Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry
SAGE is an observational post market registry with the objective of characterizing long term outcomes after treatment of uterine fibroids with the Sonata System in real world clinical practice settings.
- Trial name
- SAGE (NCT03118037)
- Testing
- Sonata System
- Where
- 9 sites in Germany, Switzerland and 1 more
- Volunteers
- 182 people
- Sponsor
- Gynesonics
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
Fibroids, Uterine, Leiomyoma
Safety and Tolerability of Collagenase Clostridium Histolyticum (EN3835) to Treat Uterine Leiomyoma (Fibroids)
This pilot study evaluates the safety and tolerability of a single injection of collagenase enzyme directly into a uterine fibroid in subjects already selected for hysterectomy or myomectomy.
- Trial name
- NCT02889848
- Testing
- Saline, EN3835
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Advance Biofactures Corporation
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
Symptomatic Uterine Fibroids
Laparoscopic Cryoablation of Uterine Fibroids
The goal of this study is to evaluate the safety \& efficacy of cryoablation using IceCure medical's IceSense3™ device for the treatment of symptomatic uterine fibroids in a percutaneous lap-assisted approach.
- Trial name
- UFREEZE-01 (NCT01735812)
- Testing
- IceSense3 system
- Where
- Israel
- Sponsor
- IceCure Medical Ltd.