Clinical trials: Uterine Bleeding
Iron Deficiency Anemia
Hypophosphatemia With Ferric Carboxymaltose Vs. Iron Dextran in Iron Deficiency Secondary to Heavy Uterine Bleeding
The primary objective of this study is to assess the safety of an investigational intravenous iron (ferric carboxymaltose [FCM]) or an equal dose of iron dextran and explore the mechanism of hypophosphatemia following…
- Trial name
- NCT01307007
- Testing
- Ferric Carboxymaltose (FCM), Iron Dextran Injection
- Volunteers
- 69 people
- Sponsor
- American Regent, 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, 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.
Postpartum Hemorrhage
Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage
The purpose of this study is to evaluate the safety and effectiveness of the Jada System in the control and reduction of primary postpartum hemorrhage.
- Trial name
- PEARLE (NCT02883673)
- Testing
- Jada System
- Where
- 15 sites in United States
- Volunteers
- 107 people
- Sponsor
- Alydia Health
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
Menorrhagia, Heavy Menstrual Bleeding
Efficacy and Safety Study of XP12B in Women With Menorrhagia
The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.
- Trial name
- NCT00386308
- Testing
- Tranexamic acid tablets
- Where
- 52 sites in United States
- Volunteers
- 196 people
- Sponsor
- Ferring Pharmaceuticals
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
Postpartum Hemorrhage
Comparison of Inhaled Oxytocin (IH) With Intramuscular (IM) Oxytocin in Pregnant Women and With Intravenous (IV) Oxytocin in Healthy Non-pregnant Women
The study will evaluate a stable, dry-powder formulation of oxytocin, with the goal of reducing post-partum hemorrhage morbidity and mortality in resource poor settings.
- Trial name
- NCT02999100
- Testing
- IH Oxytocin, IM Oxytocin, IV Oxytocin
- Where
- 3 sites in Australia, United Kingdom
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Menorrhagia, Heavy Menstrual Bleeding
Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness
The EASE Clinical Trial is prospective, multi-center, single-arm (open-label), non-randomized, clinical trial to evaluate the Minitouch Endometrial Ablation System ("Minitouch System") in premenopausal women with menorrhagia.
- Conditions
- Menorrhagia, Heavy Menstrual Bleeding, Heavy Uterine Bleeding
- Trial name
- NCT04267562
- Testing
- Minitouch System
- Where
- 5 sites in United States
- Volunteers
- 219 people, healthy volunteers welcome
- Sponsor
- MicroCube, LLC
Menorrhagia
Minerva Pivotal Study to Evaluate Safety and Efficacy of the Aurora Endometrial Ablation System Compared to Hysteroscopic Rollerball Ablation
The primary objective of this study is to evaluate the safety and effectiveness of the Aurora Endometrial Ablation System as compared to hysteroscopic rollerball endometrial ablation in reducing menstrual blood loss at 12 months…
- Trial name
- NCT01569763
- Testing
- Aurora Endometrial Ablation, Rollerball Ablation/Resection
- Where
- 13 sites in United States, Canada and 1 more
- Volunteers
- 153 people
- Sponsor
- Minerva Surgical, Inc.
Contraception, Menorrhagia
A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation Procedure Following a Successful Essure Confirmation Test
The purpose of the post approval study is to evaluate the effectiveness and safety of the Essure System when a NovaSure Endometrial Ablation procedure is performed following a successful Essure Confirmation Test.
- Trial name
- ESS-NSPAS (NCT01740687)
- Testing
- ESS305 (Essure, BAY1454032), NovaSure
- Where
- 17 sites in United States
- Volunteers
- 211 people
- Sponsor
- Bayer
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
Menorrhagia, Heavy Menstrual Bleeding
Safety Study of XP12B in Women With Menorrhagia
The purpose of this study is to evaluate the safety of XP12B in women with heavy menstrual bleeding associated with menorrhagia.
- Trial name
- NCT00113568
- Testing
- Tranexamic acid tablets (XP12B)
- Where
- 59 sites in United States
- Volunteers
- 784 people
- Sponsor
- Ferring Pharmaceuticals
Menorrhagia, Heavy Menstrual Bleeding
Efficacy and Safety of XP12B in Women With Menorrhagia
The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.
- Trial name
- NCT00401193
- Testing
- Tranexamic acid tablets
- Where
- 83 sites in United States
- Volunteers
- 304 people
- Sponsor
- Ferring Pharmaceuticals
Uterine Fibroids
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)
The primary objective of this study was 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 were to…
- Trial name
- NCT03400956
- Testing
- Vilaprisan (BAY1002670)
- Where
- 87 sites in United States, Czechia and 3 more
- Volunteers
- 103 people
- Sponsor
- Bayer
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
Breakthrough Bleeding
A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale
This is a 4-arm study to evaluate and compare bleeding patterns between three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive.
- Trial name
- NCT00394771
- Testing
- DR-1031, Seasonale®, Portia®
- Where
- 50 sites in United States
- Volunteers
- 567 people, healthy volunteers welcome
- Sponsor
- Duramed Research
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
Menorrhagia
Evaluation of Modified Treatment Regimens for Treatment of Heavy Menstrual Bleeding Using the HerOption® System
The Her Option® Cryoablation Therapy System is a closed-loop cryosurgical device that is used to ablate the endometrial lining in pre-menopausal women with menorrhagia (excessive menstrual bleeding) due to benign causes.
- Trial name
- NCT00094536
- Testing
- Extended treatment regimen using Her Option Cryotherapy
- Where
- 7 sites in United States
- Volunteers
- 82 people
- Sponsor
- CooperSurgical Inc.
Heavy Menstrual Bleeding, Uterine Fibroid
LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
The purpose of this study was to determine the long-term efficacy and safety of relugolix 40 milligrams (mg) once daily co-administered with estradiol (E2) and norethindrone acetate (NETA) for 28 weeks on heavy menstrual bleeding…
- Trial name
- NCT03412890
- Testing
- Relugolix, Estradiol/norethindrone acetate
- Where
- 150 sites in United States, Belgium and 7 more
- Volunteers
- 477 people
- Sponsor
- Myovant Sciences GmbH