A Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding
NCT03476928 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 153
Last updated 2022-07-08
Summary
To evaluate the safety and efficacy of vilaprisan in Japanese subjects with uterine fibroids and heavy menstrual bleeding (HMB).
Conditions
- Uterine Fibroids and Heavy Menstrual Bleeding
Interventions
- DRUG
-
Vilaprisan (BAY1002670)
2mg, once daily, oral
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-03-30
- Primary Completion
- 2021-07-12
- Completion
- 2021-07-12
Countries
- Japan
Study Locations
More Related Trials
-
Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids
NCT03317795 ·Status: COMPLETED ·Phase: PHASE4
-
Phase 1 Safety, Pharmacokinetics And Pharmacodynamics Study Of Recombinant Factor VIIa Variant (813d) In Adult Subjects With Hemophilia
NCT01439971 ·Status: COMPLETED ·Phase: PHASE1
-
Safety Study of XP12B in Women With Menorrhagia
NCT00113568 ·Status: COMPLETED ·Phase: PHASE3
-
A Pharmacokinetic and Clotting Activity Study of FVIII-PEGLip
NCT04592692 ·Status: UNKNOWN ·Phase: PHASE2
-
Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B
NCT02141074 ·Status: COMPLETED ·Phase: PHASE3
-
Recombinant Factor VIIa in Acute Intracerebral Haemorrhage
NCT00127283 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of Pazopanib on Bleeding in Subjects With Hereditary Haemorrhagic Telangiectasia
NCT02204371 ·Status: TERMINATED ·Phase: PHASE2
-
Use of Fibryga, a Fibrinogen Concentrate in Real World: Retrospective Collection of Clinical Data
NCT04106895 ·Status: COMPLETED
-
Clinical Study of Recombinant Human Activated Coagulation Factor VII for Injection in Patients With Hemophilia With Inhibitor
NCT05487976 ·Status: UNKNOWN ·Phase: PHASE3
-
Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery
NCT07032792 ·Status: RECRUITING ·Phase: PHASE2
-
Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor (rVWF) in the Treatment of Bleeding Episodes in Von Willebrand Disease (VWD)
NCT01410227 ·Status: COMPLETED ·Phase: PHASE3
-
Long-Term Safety and Efficacy of rFVIIIFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia A
NCT01454739 ·Status: COMPLETED ·Phase: PHASE3
-
Recombinant Factor VIIa BI (rFVIIa BI) Treatment of Acute Bleeding Episodes Per an On-demand Regimen
NCT01757405 ·Status: COMPLETED ·Phase: PHASE3
-
Pazopanib for the Treatment of Epistaxis in Hereditary Hemorrhagic Telangiectasia
NCT03850730 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2
-
Efficacy and Safety of BT200 (Rondaptivon Pegol) in Patients With Type 2B Von Willebrand Disease
NCT07273721 ·Status: RECRUITING ·Phase: PHASE2
-
Safety and Efficacy of NNC-0156-0000-0009 in Haemophilia B Patients
NCT01333111 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII in Acute Intracerebral Haemorrhage
NCT01566786 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773
NCT01395810 ·Status: COMPLETED ·Phase: PHASE3
-
Study of the Efficacy of Human Recombinant Factor VIII (Kogenate FS) Reconstituted in Pegylated Liposomes.
NCT00245297 ·Status: COMPLETED ·Phase: PHASE2
-
Trial of NovoSeven® in Haemophilia - Joint Bleeds
NCT00108797 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of XP12B in Women With Menorrhagia
NCT00401193 ·Status: COMPLETED ·Phase: PHASE3
-
Non-Interventional Study of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors
NCT01586936 ·Status: COMPLETED
-
Efficacy and Safety Study of Prophylactic Versus On-Demand Treatment With Feiba NF in Subjects With Hemophilia A or B and a High Titer Inhibitor
NCT00851721 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Pediatric Subjects With Hemophilia A
NCT01458106 ·Status: COMPLETED ·Phase: PHASE3
-
Low Molecular Weight Heparin in Recurrent Miscarriage With Negative Antiphospholipid Antibodies
NCT01608347 ·Status: COMPLETED ·Phase: PHASE4