Clinical trials: Soft Tissue Bleeding
Soft Tissue Surgical Bleeding
Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Soft Tissue Open Surgeries
This study is designed to assess the safety and efficacy of fibrin sealant (FS) Grifols in patients undergoing elective (non-emergency) soft tissue open surgery where bleeding may be present.
- Trial name
- NCT01731938
- Testing
- Fibrin Sealant (FS) Grifols, Surgicel®
- Where
- 25 sites in United States, Hungary and 1 more
- Volunteers
- 327 people
- Sponsor
- Grifols Biologicals, LLC
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
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
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
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
Heavy Menstrual Bleeding, Uterine Fibroids
Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
This randomized multicenter phase 3b study seeks to evaluate the safety of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in…
- Trial name
- NCT03271489
- Testing
- Elagolix, Estradiol /norethindrone acetate (E2/NETA)
- Where
- 157 sites in United States, Puerto Rico
- Volunteers
- 478 people
- Sponsor
- AbbVie
Uterine Fibroids
Post Market TRUST 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
- TRUST (NCT01563783)
- Testing
- Global Fibroid Ablation (GFA), Abdominal or Laparoscopic Myomectomy, Uterine Artery Embolization (UAE)
- Where
- Canada
- Volunteers
- 84 people
- Sponsor
- Acessa Health, Inc.
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
Leiomyoma, Menorrhagia
Treatment of Uterine Fibroids With Asoprisnil(J867)
The objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.
- Conditions
- Leiomyoma, Menorrhagia, Metrorrhagia
- Trial name
- NCT00152269
- Testing
- Asoprisnil
- Volunteers
- 475 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 Fibroid, Vaginal Bleeding.
Efficacy Study of Vaginal Mifepristone to Treat Uterine Fibroids
The purpose of this study is to evaluate the effect of daily dosage of vaginally mifepristone on reduction of uterine fibroids size and the symptoms associated with uterine fibroids.
- Trial name
- NCT00881140
- Testing
- mifepristone vaginal tablets
- Where
- 2 sites in Israel
- Volunteers
- 30 people
- Sponsor
- BioPro Medical Ltd
Heavy Menstrual Bleeding, Uterine Fibroid
LIBERTY 1: 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
- NCT03049735
- Testing
- Relugolix, Estradiol/norethindrone acetate
- Where
- 110 sites in United States, Brazil and 4 more
- Volunteers
- 388 people
- Sponsor
- Myovant Sciences GmbH
Uterine Fibroids, Bleeding
A Clinical Study to Evaluate Safety of the ExAblate 2100 UF V2 System in the Treatment of Symptomatic Uterine Fibroids
The first magnetic resonance-guided focused ultrasound (MRgFUS) treatment of uterine fibroid using the ExAblate 2000 system was performed in 2001.
- Conditions
- Uterine Fibroids, Bleeding, Pain
- Trial name
- NCT01092988
- Testing
- Exablate 2100
- Where
- 4 sites in France, Israel and 2 more
- Volunteers
- 40 people
- Sponsor
- InSightec
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