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Last Updated: November 21, 2019

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR VILAPRISAN

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Clinical Trials for Vilaprisan

Trial ID Title Status Sponsor Phase Summary
NCT02262663 Study in Healthy Young Women to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of Vilaprisan Completed Bayer Phase 1 This is a study in healthy women of reproductive age to investigate the pharmacodynamics (mainly ovarian activity), pharmacokinetics and safety of vilaprisan after daily oral administration of 4 different doses over 84 days, using a randomized, parallel-group, multicenter design.
NCT02456129 Study in Postmenopausal Women to Investigate the Drug-drug Interaction (DDI) Between Itraconazole(ITZ) and Orally Administered Vilaprisan; Absolute Bioavailability Using Intravenous Microtracer Dose of [14C]Vilaprisan Completed Bayer Phase 1 This is a study in postmenopausal women to investigate the Drug-drug interaction (DDI) between itraconazole(ITZ) and orally administered vilaprisan; absolute bioavailability using intravenous microtracer dose of [14C]vilaprisan.
NCT02465814 Assess Safety and Efficacy of Vilaprisan in Patients With Uterine Fibroids Completed Bayer Phase 2 The study is performed to assess the efficacy of Vilaprisan (BAY1002670) in patients with uterine fibroids compared to placebo and ulipristal. It is also aimed to evaluate the safety of vilaprisan in subjects with uterine fibroids. Further, data on population pharmacokinetic (PK)/ pharmacodynamic (PD) relationship for vilaprisan in subjects with uterine fibroids will be supplemented.
NCT02975440 Drug-drug Interaction Study Between Orally Administered Rifampicin and Vilaprisan Recruiting Bayer Phase 1 This study will be conducted in a single center, open-label study with a single group fixed sequence design to evaluate the effect of repeated oral administration of 600 mg RIF(Rifampicin) given once daily over 11 days on the single oral dose pharmacokinetics of VPR(Vilaprisan) and on MDZ(Midazolam) as a reference (probe) substance.
NCT03092999 Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1002670 (Vilaprisan) Recruiting Bayer Phase 1 Evaluate the potential effect of hepatic impairment on the pharmacokinetics, safety and tolerability of BAY1002670 (vilaprisan)
NCT03194646 Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Not yet recruiting Bayer Phase 3 The study is performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care
NCT03210246 Drug-drug Interaction Study: Influence of Vilaprisan on Pharmacodynamics (PD) and Pharmacokinetics (PK) of a Combined Oral Contraceptive (COC) Not yet recruiting Bayer Phase 1 This study will be performed as a multi-center, randomized, double-blind study in 60 healthy women (2 groups of 30 women) to investigate ovarian activity during simultaneous intake of a COC (containing the estrogen EE and the progestin LNG) and the progesterone receptor modulator (PRM) vilaprisan.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Vilaprisan

Condition Name

Condition Name for
Intervention Trials
Leiomyoma 6
Uterine Fibroids 3
Endometriosis 3
Clinical Trial, Phase I 2
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Condition MeSH

Condition MeSH for
Intervention Trials
Leiomyoma 10
Myofibroma 9
Endometriosis 3
Hemorrhage 1
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Clinical Trial Locations for Vilaprisan

Trials by Country

Trials by Country for
Location Trials
United States 96
Japan 63
China 45
Germany 18
Italy 18
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Trials by US State

Trials by US State for
Location Trials
Florida 5
Georgia 4
California 4
Alabama 4
Washington 4
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Clinical Trial Progress for Vilaprisan

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 6
Phase 2 2
Phase 1 7
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Recruiting 9
Not yet recruiting 3
Completed 3
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Clinical Trial Sponsors for Vilaprisan

Sponsor Name

Sponsor Name for
Sponsor Trials
Bayer 15
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 15
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