Clinical trials: Fibroid Uterus
Uterine Fibroids, With Unexplained Infertility
ExAblate Treatment of Uterine Fibroids for Fertility Enhancement
The objective of this trial is to evaluate the efficacy and safety of the ExAblate 2000 system for enhancement of fertility in women with non-hysteroscopically resectable uterine fibroids, who are diagnosed with unexplained…
- Trial name
- NCT00730886
- Testing
- ExAblate 2000, Myomectomy
- Where
- 6 sites in United States
- Volunteers
- 2 people
- Sponsor
- InSightec
Uterine Leiomyomata
A Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata
A study of 3 doses of Progenta versus placebo versus Lucron Depot for treatment of leiomyomata.
- Trial name
- NCT01069094
- Testing
- Progenta, Lucron Depot
- Where
- Poland
- Volunteers
- 29 people
- Sponsor
- Repros Therapeutics Inc.
Uterine Leiomyoma, Uterine Fibroids
Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
The objectives of this randomized withdrawal study are to evaluate the long-term efficacy and safety of the combination of relugolix, estradiol (E2) and norethindrone acetate (NETA), once daily, for up to 104 weeks in patients…
- Trial name
- NCT03751124
- Testing
- Relugolix, Estradiol/norethindrone acetate
- Where
- 104 sites in United States, Brazil and 6 more
- Volunteers
- 229 people
- Sponsor
- Myovant Sciences GmbH
Uterine Fibroids
Therapeutic Magnetic Resonance Imaging (MRI)-Guided High Intensity Focused Ultrasound (HIFU) Ablation of Uterine Fibroids
This study is to confirm the safety and technical effectiveness of MRI guided High Intensity Focused Ultrasound (HIFU) in ablating uterine tissue associated with symptomatic leiomyomas.
- Trial name
- NCT00897897
- Testing
- Philips MRI-guided HIFU system
- Where
- 4 sites in France, Germany and 2 more
- Volunteers
- 33 people
- Sponsor
- Philips Healthcare
Uterine Fibroids
An Extension Study Evaluating Safety and Efficacy of Proellex® In Women Who Have Previously Completed ZPU 003 Ext
An open label, extension study for subjects completing the ZPU-003 Ext 1 study.
- Trial name
- NCT00958893
- Testing
- 25 mg Proellex
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Repros Therapeutics Inc.
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)
Leiomyoma, Uterine Hemorrhage
A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas
This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids
- Trial name
- NCT02147158
- Testing
- Ulipristal acetate (UPA)
- Where
- 63 sites in United States, Canada
- Volunteers
- 432 people
- Sponsor
- Allergan
Endometriosis, Ovarian Cyst
PerClot Compared to Usual Care in Gynaecology Procedures
This study is a post market, multi-centre, randomised study evaluating PerClot compared to usual care. PerClot is a CE marked device and is currently used as a haemostat in gynaecological surgery throughout Europe.
- Conditions
- Endometriosis, Ovarian Cyst, Menorrhagia, Cancer
- Trial name
- NCT02835391
- Testing
- PerClot, Floseal, Surgicel, Surgiflo, Arista, Electrocautery/Diatermy
- Where
- Spain
- Volunteers
- 90 people
- Sponsor
- CryoLife Europa
Symptomatic Uterine Fibroids
Post Market TRUST - U.S.A. Study
This Post Market study is being conducted to compare the direct and indirect cost of three approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of symptomatic uterine fibroids.
- Trial name
- NCT02163525
- Testing
- Global Fibroid Ablation (GFA), Abdominal or Laparoscopic Myomectomy, Uterine Artery Embolization (UAE)
- Where
- 9 sites in United States
- Volunteers
- 114 people
- Sponsor
- Acessa Health, Inc.
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, 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.
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.
Uterine Fibroids
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
This is a multicentre, Phase III, efficacy and safety open-label study with PGL4001 10mg once daily for 3 months, blinded towards the administration of progestin or placebo after end of PGL4001 treatment.
- Trial name
- PEARLIII (NCT01156857)
- Testing
- PGL4001, progestin
- Where
- 23 sites in Austria, Belgium and 2 more
- Volunteers
- 209 people
- Sponsor
- PregLem SA
Uterine Fibroids, Endometriosis
A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis
The purpose of this clinical trial to characterize changes in bone mineral density during continuous treatment with relugolix combination tablet for up to 48 months (4 years) and 1 year of post-treatment follow-up in…
- Trial name
- NCT05862272
- Testing
- Relugolix Combination Tablet
- Where
- 120 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Sumitomo Pharma Switzerland GmbH
Uterine Fibroids, Uterine Leiomyomata
Pilot Study of MRI-Guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids
Uterine fibroids (leiomyomas) are a common cause of heavy uterine bleeding and pain in reproductive aged women and are the most common cause of hysterectomy in the United States.
- Trial name
- NCT00837161
- Testing
- Philips MR guided HIFU system
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- Philips Healthcare
Leiomyoma, Menorrhagia
Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids
The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.
- Conditions
- Leiomyoma, Menorrhagia, Metrorrhagia
- Trial name
- NCT00156195
- Testing
- Asoprisnil
- Volunteers
- 523 people
- 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
Leiomyoma
Magnetic Resonance (MR) Guided Focused Ultrasound Surgery of Uterine Fibroids
The goal of this study is to develop additional long term data to evaluate the safety and effectiveness of this treatment. Indications for use for this system is: 'The ExAblate is intended to ablate uterine fibroid tissue in pre…
- Trial name
- NCT00131365
- Testing
- ExAblate 2000
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- InSightec
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, 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.