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Clinical trials for Relugolix

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   44334   clinical trials with a EudraCT protocol, of which   7366   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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    8 result(s) found for: Relugolix. Displaying page 1 of 1.
    EudraCT Number: 2017-000160-15 Sponsor Protocol Number: MVT-601-3201 Start Date*: 2017-07-25
    Sponsor Name:Myovant Sciences GmbH
    Full Title: HERO: A Multinational Phase 3 Randomized, Open-label, Parallel Group Study to Evaluate the Safety and Efficacy of Relugolix in Men with Advanced Prostate Cancer
    Medical condition: Androgen-sensitive advanced prostate cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060862 Prostate cancer PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: NL (Completed) SE (Completed) GB (GB - no longer in EU/EEA) BE (Completed) AT (Completed) SK (Completed) DK (Completed) FI (Completed) ES (Completed) DE (Completed) PL (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-001588-19 Sponsor Protocol Number: MVT-601-3101 Start Date*: 2017-11-01
    Sponsor Name:Myovant Sciences GmbH
    Full Title: SPIRIT 1: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Administered with and without Low-Dose Estradiol and Norethindrone Ac...
    Medical condition: Endometriosis
    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: CZ (Completed) ES (Completed) HU (Completed) BE (Completed) PL (Completed) BG (Completed) PT (Completed) FI (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)
    EudraCT Number: 2016-005113-50 Sponsor Protocol Number: MVT-601-3002 Start Date*: 2017-05-22
    Sponsor Name:Myovant Sciences GmbH
    Full Title: LIBERTY 2: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Co Administered with and without Low-Dose Estradiol and Norethindron...
    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
    20.0 100000004864 10046783 Uterine fibroid LLT
    Population Age: Adults Gender: Female
    Trial protocol: HU (Completed) CZ (Completed) BE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2016-003727-27 Sponsor Protocol Number: MVT-601-3001 Start Date*: 2017-06-12
    Sponsor Name:Myovant Sciences GmbH c/o Vischer AG
    Full Title: LIBERTY 1: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Co Administered with and without Low-Dose Estradiol and Norethindron...
    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
    20.0 100000004864 10046783 Uterine fibroid LLT
    Population Age: Adults Gender: Female
    Trial protocol: GB (Completed) DE (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-004066-10 Sponsor Protocol Number: MVT-601-3103 Start Date*: 2018-10-19
    Sponsor Name:Myovant Sciences GmbH
    Full Title: SPIRIT EXTENSION: An International Phase 3 Open-Label, Single-Arm, Safety and Efficacy Extension Study to Evaluate Relugolix Co-Administered with Low-Dose Estradiol and Norethindrone Acetate in Wom...
    Medical condition: Endometriosis
    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: GB (GB - no longer in EU/EEA) ES (Ongoing) HU (Completed) BE (Completed) FI (Completed) SE (Completed) PL (Completed) CZ (Completed) BG (Completed) PT (Completed) IT (Completed) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2017-001632-19 Sponsor Protocol Number: MVT-601-3102 Start Date*: 2017-12-01
    Sponsor Name:Myovant Sciences GmbH
    Full Title: SPIRIT 2: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Administered with and without Low-Dose Estradiol and Norethindrone Ac...
    Medical condition: Endometriosis
    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: SE (Completed) CZ (Completed) PL (Completed) GB (Completed) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2017-003310-74 Sponsor Protocol Number: MVT-601-3003 Start Date*: 2018-03-21
    Sponsor Name:Myovant Sciences GmbH
    Full Title: LIBERTY EXTENSION: An International Phase 3 Open-Label, Single-Arm, Long-Term Efficacy and Safety Extension Study to Evaluate Relugolix Co-Administered with Low-Dose Estradiol and Norethindrone Ace...
    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: GB (GB - no longer in EU/EEA) HU (Completed) BE (Completed) CZ (Completed) PL (Prematurely Ended) 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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