Clinical trials: Uterine Hemorrhage
Adenomyosis
Placebo-controlled Proof of Concept Study of Epelsiban in Women With Adenomyosis
The primary objective of the study is to assess the efficacy, safety, and tolerability of epelsiban compared with placebo in treatment of women with adenomyosis.
- Trial name
- NCT02794467
- Testing
- Epelsiban
- Where
- 13 sites in United States
- Sponsor
- GlaxoSmithKline
Cervical Lesion, Vaginal Bleeding
RWE Study in the Treatment of Cervical Lesions of Various Etiology
The aim of the study was to assess the post-market performance and tolerability of Cerviron® ovules in the treatment and management of cervical lesions of different etiologies.
- Trial name
- NCT05668806
- Testing
- Cerviron
- Where
- 15 sites in Romania
- Volunteers
- 345 people
- Sponsor
- Perfect Care Distribution
Menorrhagia
A CLinical Study to Evaluate the Safety And Effectiveness of the CeRene DevIce to Treat HeavY Menstrual Bleeding
The purpose of the study is to evaluate the safety and effectiveness of the Cerene Cryotherapy Device in reducing menstrual bleeding in women with heavy menstrual bleeding (menorrhagia) due to benign causes for whom child bearing…
- Trial name
- CLARITY (NCT02842736)
- Testing
- Cerene(R) Cryotherapy Device
- Where
- 12 sites in United States, Canada and 1 more
- Volunteers
- 242 people
- Sponsor
- Channel Medsystems
Uterine Bleeding Profile Prediction
A Study to Learn More About How a Smartphone App Called MyIUS Predicts Future Menstrual Bleeding in Women After They Have Begun Using Intrauterine Birth Control Method (a Birth Control Device is Inserted Into a Woman's Uterus by Her Doctor)
Researchers are looking to learn more about future menstrual bleeding in women who have started using intrauterine contraception methods.
- Trial name
- MyIUS (NCT04989595)
- Testing
- MyIUS app
- Where
- 6 sites in Brazil, Denmark and 4 more
- Volunteers
- 3,045 people, healthy volunteers welcome
- Sponsor
- Bayer
Post Partum Haemorrhage
Compare Efficacy of Oxytocin Administrations on Postpartum Uterine Contractility
This is a Phase I open-label, parallel-group clinical study in healthy term pregnant females undergoing a caesarean section. Two administrations of oxytocin will be tested, after which uterine contractility will be assessed.
- Trial name
- NCT02908126
- Testing
- Oxytocin
- Where
- Sweden
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Oxytone Bioscience BV
Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage
HEMOLEVEN® Expanded Access Program Prevention of Surgical/Postpartum Hemorrhage Severe Inherited Factor XI Deficiency
The objective of the Expanded Access Program is to provide HEMOLEVEN, a replacement coagulation factor XI, to patients with severe inherited factor XI deficiency where, in the opinion of the treating physician, the benefits of…
- Conditions
- Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage, Surgery
- Trial name
- EAP (NCT01701947)
- Testing
- Hemoleven
- Where
- United States
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
Postpartum Uterine Bleeding
Belfort Dildy- Obstetrical Tamponade System Post-Marketing Surveillance Program
This is an open, post-marketing surveillance study obtaining data retrospectively on 300 women, of any age, treated with the BD-OTS for postpartum uterine bleeding.
- Trial name
- NCT01198652
- Where
- 11 sites in United States
- Volunteers
- 300 people
- Sponsor
- Glenveigh Medical
Anemia
Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients
The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state.
- Trial name
- NCT00548860
- Testing
- Ferric Carboxymaltose, Standard Medical Care (SMC)
- Where
- United States
- Volunteers
- 2,018 people
- Sponsor
- American Regent, Inc.
Uterine Fibroid
Evaluating Efficacy of Intravenous Carbetocin Versus Intramyometrial Injection of Adrenaline in Reducing Blood Loss
Uterine fibroids, affecting 20-50% of all women ,and are benign tumors that arise from myometrial cells of the uterine smooth muscle tissue.
- Trial name
- NCT05986266
- Testing
- Carbetocin
- Where
- Egypt
- Volunteers
- 62 people
- Sponsor
- Egymedicalpedia
Uterine Fibroids, Heavy Menstrual Bleeding
Efficacy and Safety of BG2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids.
The primary objective of this study is to demonstrate the superior efficacy versus placebo of BG2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in…
- Trial name
- NCT05620355
- Testing
- BG2109, Add-back therapy
- Where
- 29 sites in China
- Volunteers
- 312 people
- Sponsor
- Bio Genuine (Shanghai) Biotech Co., Ltd.
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.
Menorrhagia, Dysmenorrhea
Prospective, Non-interventional, Multi-center Safety Study of Mirena for Heavy Menstrual Bleeding and Dysmenorrhea
The primary objective in this study is collecting post-marketing information on the safety. Thus, it includes information under the routine clinical practice on adverse events (AEs) and adverse drug reactions (ADRs) including…
- Trial name
- J-MIRAI (NCT02475356)
- Testing
- Levonorgestrel IUS (Mirena, BAY86-5028)
- Where
- Japan
- Volunteers
- 601 people
- Sponsor
- Bayer
Primary Ovarian Insufficiency, Vaginitis
A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions.
The purpose of this study is to assess the bioequivalence and food effect for a new Premarin formulation compared with a Premarin reference tablet in Japanese healthy postmenopausal women.
- Conditions
- Primary Ovarian Insufficiency, Vaginitis, Metrorrhagia, Menopause
- Trial name
- NCT01436513
- Testing
- Premarin reference tablet (fasted), Premarin new tablet (fasted), Premarin reference tablet (fed)
- Where
- Japan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Pfizer
Von Willebrand Disease (VWD), Heavy Menstrual Bleeding (HMB)
HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB
The purpose of this study is to evaluate the safety, tolerability, efficacy, and pharmacodynamics (PD) of multiple doses of ALN-6400 in adult and adolescent patients with VWD and HMB
- Trial name
- HMBeacon (NCT07575308)
- Testing
- ALN-6400
- Where
- 21 sites in United States, Netherlands and 3 more
- Volunteers
- 24 people
- Sponsor
- Alnylam Pharmaceuticals
Menorrhagia
Menorrhagia Study in Women With Treatment-resistant Menorrhagia
The aim of this study is to explore effects of the investigational product for the treatment of treatment-resistant menorrhagia without organic cause.
- Trial name
- NCT00288691
- Testing
- Asoprisnil (BAY86-5294)
- Volunteers
- 26 people
- Sponsor
- Bayer
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, Heavy Menstrual Bleeding
Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
The primary objective of this study is to demonstrate the superior efficacy versus placebo of OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids…
- Trial name
- PRIMROSE 2 (NCT03070951)
- Testing
- OBE2109, Add-back
- Where
- 96 sites in United States, Bulgaria and 7 more
- Volunteers
- 511 people
- Sponsor
- ObsEva SA
Heavy Menstrual Bleeding, Abnormal Uterine Bleeding
A Registry to Gather Real World Use Data on the Cerene® Cryotherapy Device
Channel Medsystems, Inc., the manufacturer of the Cerene® Cryotherapy Device (Cerene), is initiating a prospective, observational registry, the Progress registry, to gather data during real world utilization of the Cerene®…
- Conditions
- Heavy Menstrual Bleeding, Abnormal Uterine Bleeding, Menorrhagia
- Trial name
- Progress (NCT05922657)
- Testing
- Cerene
- Where
- 2 sites in United States
- Volunteers
- 300 people
- Sponsor
- Channel Medsystems
Menorrhagia
Post Approval NovaSure Essure Labeling Study
This post approval, observational study is being conducted to further evaluate the safety of the NovaSure Endometrial Ablation System when it is performed in the presence of Essure micro-inserts.
- Trial name
- PANEL (NCT01934244)
- Testing
- NovaSure Endometrial Ablation
- Where
- 14 sites in United States
- Volunteers
- 318 people
- Sponsor
- Hologic, Inc.
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