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Clinical trials for Vilaprisan

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44343   clinical trials with a EudraCT protocol, of which   7372   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    7 result(s) found for: Vilaprisan. Displaying page 1 of 1.
    EudraCT Number: 2013-004768-72 Sponsor Protocol Number: BAY1002670/15792 Start Date*: 2018-06-11
    Sponsor Name:Bayer AG
    Full Title: A randomized, double-blind, parallel-group, multicenter Phase 2b study to assess the efficacy and safety of two different doses of vilaprisan (BAY 1002670) versus placebo in women with symptomatic ...
    Medical condition: Pre-menopausal women 18 years and older with confirmed endometriosis and moderate to severe endometriosis-associated pelvic pain (EAPP), otherwise in good general health.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038604 - Reproductive system and breast disorders 10014778 Endometriosis PT
    Population Age: Adults Gender: Female
    Trial protocol: AT (Completed) FI (Completed) DK (Prematurely Ended) SE (Prematurely Ended) ES (Prematurely Ended) DE (Prematurely Ended) HU (Completed) BG (Prematurely Ended) CZ (Prematurely Ended) PL (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-002855-48 Sponsor Protocol Number: BAY1002670/15789 Start Date*: 2017-07-12
    Sponsor Name:Bayer AG
    Full Title: A randomized, parallel-group, multicenter study to assess the efficacy and safety of vilaprisan in subjects with uterine fibroids
    Medical condition: Leiomyoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10046784 Uterine fibroids LLT
    20.0 100000004864 10016628 Fibroids LLT
    20.0 100000004864 10022794 Intramural leiomyoma of uterus LLT
    Population Age: Adults Gender: Female
    Trial protocol: IE (Completed) SE (Completed) CZ (Completed) HU (Prematurely Ended) FI (Completed) AT (Prematurely Ended) NO (Prematurely Ended) DE (Completed) ES (Prematurely Ended) GB (GB - no longer in EU/EEA) DK (Completed) BE (Completed) SK (Completed) LT (Completed) NL (Prematurely Ended) PT (Completed) BG (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-004221-41 Sponsor Protocol Number: BAY1002670/17541 Start Date*: Information not available in EudraCT
    Sponsor Name:Bayer HealthCare AG
    Full Title: A randomized, parallel-group, double-blind placebo-controlled and open label active-controlled, multi-center study to assess the efficacy and safety of vilaprisan in patients with uterine fibroids
    Medical condition: Leiomyoma
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004864 10046784 Uterine fibroids LLT
    17.1 100000004864 10016628 Fibroids LLT
    17.1 100000004864 10022794 Intramural leiomyoma of uterus LLT
    Population Age: Adults Gender: Female
    Trial protocol: SE (Completed) DE (Completed) PT (Completed) NL (Completed) GB (Completed) FI (Completed) AT (Completed) CZ (Completed) HU (Completed) LT (Completed) BE (Completed) ES (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-003561-26 Sponsor Protocol Number: BAY1002670/15790 Start Date*: 2017-12-14
    Sponsor Name:Bayer AG
    Full Title: A randomized, parallel-group, double-blind and placebo-controlled, multicenter study to assess the efficacy and safety of vilaprisan in subjects with uterine fibroids
    Medical condition: Leiomyoma
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10016628 Fibroids LLT
    21.1 100000004864 10046784 Uterine fibroids LLT
    21.1 100000004864 10022794 Intramural leiomyoma of uterus LLT
    Population Age: Adults Gender: Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2016-004822-41 Sponsor Protocol Number: BAY1002670/16953 Start Date*: 2017-07-13
    Sponsor Name:Bayer AG
    Full Title: An open-label, parallel-group, randomized, multicenter study to assess the safety and efficacy of vilaprisan in subjects with uterine fibroids versus standard of care
    Medical condition: Women, 18 years or older, diagnosis of uterine fibroid(s) documented by ultrasound at screening and/or during a uterine preserving procedure within 3 months prior to screening in subjects with high...
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10016628 Fibroids LLT
    Population Age: Adults Gender: Female
    Trial protocol: CZ (Completed) FI (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2017-002997-38 Sponsor Protocol Number: BAY1002670/15787 Start Date*: 2018-01-10
    Sponsor Name:Bayer AG
    Full Title: A randomized, parallel-group, double-blind and open-label, placebo-controlled, multicenter study to assess the efficacy and safety of vilaprisan in subjects with uterine fibroids
    Medical condition: Leiomyoma
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10016628 Fibroids LLT
    21.1 100000004864 10046784 Uterine fibroids LLT
    21.1 100000004864 10022794 Intramural leiomyoma of uterus LLT
    Population Age: Adults Gender: Female
    Trial protocol: CZ (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2013-003945-40 Sponsor Protocol Number: BAY1002670/15788 Start Date*: 2014-05-07
    Sponsor Name:Bayer HealthCare AG
    Full Title: A randomized, parallel-group, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of different doses of BAY 1002670 in subjects with uterine fibroids over 3 months
    Medical condition: Women, 18 to 50 years old, with uterine fibroids documented by transvaginal or abdominal ultrasound at screening with at least 1 uterine fibroid with largest diameter >=3.0 cm and heavy menstrual b...
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004864 10046784 Uterine fibroids LLT
    16.1 100000004864 10016628 Fibroids LLT
    16.1 100000004864 10022794 Intramural leiomyoma of uterus LLT
    Population Age: Adults Gender: Female
    Trial protocol: SE (Completed) FI (Completed) NO (Completed) HU (Completed) CZ (Completed) BE (Completed) ES (Completed) BG (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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