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Clinical trials for HMB

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   44344   clinical trials with a EudraCT protocol, of which   7373   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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    10 result(s) found for: HMB. Displaying page 1 of 1.
    EudraCT Number: 2016-003557-15 Sponsor Protocol Number: HMB-ICU Start Date*: 2018-08-31
    Sponsor Name:Guy's and St Thomas NHS Foundation Trust
    Full Title: A Study to Investigate the Effect of β-Hydroxy-β-Methylbutyrate (HMB) on Skeletal Muscle Wasting in Early Critical Illness.
    Medical condition: Critical illness
    Disease: Version SOC Term Classification Code Term Level
    20.0 10018065 - General disorders and administration site conditions 10077264 Critical illness PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    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: 2014-003408-65 Sponsor Protocol Number: Start Date*: 2016-08-26
    Sponsor Name:University of Edinburgh [...]
    1. University of Edinburgh
    2. NHS Lothian
    Full Title: Ulipristal acetate versus conventional management of heavy menstrual bleeding (HMB; including uterine fibroids): a randomised controlled trial and exploration of mechanism of action (UCON trial)
    Medical condition: Heavy menstrual bleeding
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004864 10046784 Uterine fibroids LLT
    18.0 10038604 - Reproductive system and breast disorders 10027313 Menorrhagia PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    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: 2012-003405-98 Sponsor Protocol Number: dexFEMv2 Start Date*: 2012-12-03
    Sponsor Name:ACCORD University of Edinburgh [...]
    1. ACCORD University of Edinburgh
    2. ACCORD, NHS Lothian
    Full Title: Developmental Clinical Studies - Reversing endometrial glucocorticoid deficiency in heavy menstrual bleeding
    Medical condition: Endometrial glucocorticoid deficiency in Heavy Menstrual Bleeding
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038604 - Reproductive system and breast disorders 10027313 Menorrhagia PT
    Population Age: Adults Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-002138-35 Sponsor Protocol Number: MEDEA Start Date*: 2019-11-12
    Sponsor Name:Amsterdam University Medical Centers - location AMC
    Full Title: Heavy menstrual bleeding in premenopausal women treated with direct oral anticoagulants - the MEDEA study
    Medical condition: Heavy menstrual bleeding associated with direct oral anticoagulants in premenopausal women.
    Disease: Version SOC Term Classification Code Term Level
    24.0 100000004872 10027313 Menorrhagia LLT
    20.0 10042613 - Surgical and medical procedures 10053468 Anticoagulant therapy PT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2013-000082-37 Sponsor Protocol Number: M12-813 Start Date*: 2013-12-23
    Sponsor Name:Abbvie Deutschland GmbH & Co. KG
    Full Title: A Phase 2b Study to Evaluate the Safety and Efficacy of Elagolix in Premenopausal Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids
    Medical condition: Heavy menstrual bleeding associated with uterine fibroids
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004864 10046784 Uterine fibroids LLT
    Population Age: Adults Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2018-001368-43 Sponsor Protocol Number: MVT-601-035 Start Date*: 2019-01-21
    Sponsor Name:Myovant Sciences GmbH
    Full Title: An International Phase 3 Double-Blind, Placebo-controlled, Randomized Withdrawal Study of Relugolix Co-administered with Estradiol and Norethindrone Acetate in Women with Heavy Menstrual Bleeding A...
    Medical condition: heavy menstrual bleeding associated with uterine fibroids
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004872 10027331 Menstrual flow altered LLT
    21.1 100000004864 10046783 Uterine fibroid LLT
    Population Age: Adults Gender: Female
    Trial protocol: CZ (Completed) HU (Completed) BE (Completed) IT (Completed)
    Trial results: (No results available)
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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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