Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Estetrol

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   44338   clinical trials with a EudraCT protocol, of which   7368   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    11 result(s) found for: Estetrol. Displaying page 1 of 1.
    EudraCT Number: 2015-004018-44 Sponsor Protocol Number: MIT-Do0001-C201 Start Date*: 2016-04-08
    Sponsor Name:Donesta Bioscience BV
    Full Title: A Multicentre Dose-Finding, Randomised, Double-Blind, Placebo-Controlled Study to Select the Daily Oral Dose of Estetrol (E4) for the Treatment of Vasomotor Symptoms in Post-Menopausal Women.
    Medical condition: Vasomotor Symptoms in Post-Menopausal Women
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004872 10036268 Post-menopausal bleeding LLT
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed) NL (Completed) PL (Completed) GB (Completed) CZ (Completed) IE (Completed)
    Trial results: View results
    EudraCT Number: 2006-006542-34 Sponsor Protocol Number: PR3076 Start Date*: 2007-01-08
    Sponsor Name:Pantarhei Bioscience B.V.
    Full Title: Preoperative hormone therapy for pre- and postmenopausal women with ER positive breast cancer: A double blind randomized parallel group phase II trial, comparing the effect of 2 weeks of preoperati...
    Medical condition: breast cancer
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2007-005476-14 Sponsor Protocol Number: PR3081 Start Date*: 2007-11-09
    Sponsor Name:Pantarhei Bioscience BV
    Full Title: A feasibility study into the contraceptive effect of estetrol alone or combined with either progesterone or desogestel by daily oral administration to healthy female volunteers for 28 days
    Medical condition: Only healthy volunteers will participate in this clinical trial. Intended indication: contraception.
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2010-019865-26 Sponsor Protocol Number: ES-CO2 Start Date*: 2010-07-15
    Sponsor Name:Estetra S.A.
    Full Title: A randomised, open-label, multi-centre, dose-finding study to evaluate cycle control of 15 mg or 20 mg estetrol combined with either 150 μg levonorgestrel or 3 mg drospirenone, compared to a combin...
    Medical condition: Only healthy premenopausal volunteers will participate in this clinical trial. Intended indication: contraception.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10036556 Pregnancy LLT
    Population Age: Adults Gender: Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2009-011858-17 Sponsor Protocol Number: PR3095 Start Date*: 2009-09-25
    Sponsor Name:Pantarhei Bioscience BV [...]
    1. Pantarhei Bioscience BV
    2. S.A. Odyssea Pharma
    Full Title: A dose finding study with an active control group (Yasmin) to assess the contraceptive efficacy and the efficacy on liver function of estetrol combined with 3 mg drospirenone by daily oral administ...
    Medical condition: Only healthy premenopausal volunteers will participate in this clinical trial. Intended indication: contraception.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036556 Pregnancy LLT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2007-003537-16 Sponsor Protocol Number: PR3084 Start Date*: 2008-09-04
    Sponsor Name:Erasmus MC
    Full Title: Estetrol Therapy in Sjogren's Syndrome: An Open Proof of Concept Study
    Medical condition: Primary Sjogren's Syndrome
    Disease: Version SOC Term Classification Code Term Level
    9.1 10040767 Sjogren's syndrome LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-003403-33 Sponsor Protocol Number: MIT-Co001-C101 Start Date*: 2021-01-20
    Sponsor Name:NEURALIS s.a.
    Full Title: A Randomized, Double-blind, Placebo-controlled Trial to Determine the Safety and Efficacy of Estetrol (E4) for the Treatment of patients with Confirmed SARS-CoV-2 Infection
    Medical condition: Confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection with moderate COVID-19.
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004862 10053983 Corona virus infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2016-004267-40 Sponsor Protocol Number: MIT-Es0001-C202 Start Date*: 2017-01-16
    Sponsor Name:Estetra SPRL
    Full Title: A SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, TWO-ARM STUDY TO EVALUATE THE OVARIAN FUNCTION INHIBITION OF A MONOPHASIC COMBINED ORAL CONTRACEPTIVE (COC) CONTAINING 15 MG ESTETROL (E4) AND 3 MG DROSPIRE...
    Medical condition: Hormonal contraception in woman seeking contraception
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004865 10073728 Hormonal contraception LLT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2019-003002-27 Sponsor Protocol Number: MIT-Es001-C303 Start Date*: 2020-10-14
    Sponsor Name:Estetra SRL
    Full Title: A Multicenter, Open-label, Single-Arm Study to Evaluate the Safety, Compliance and Pharmacokinetics associated with the use of a Combined Oral Contraceptive Containing 15 mg Estetrol monohydrate an...
    Medical condition: Contraception
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004865 10030971 Oral contraceptive LLT
    Population Age: Adolescents, Under 18 Gender: Female
    Trial protocol: FI (Completed) EE (Completed) LV (Completed) SE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2019-001289-14 Sponsor Protocol Number: MIT-Do001-C301 Start Date*: 2020-02-05
    Sponsor Name:Estetra SRL
    Full Title: A Randomized Double-blind Placebo Controlled Phase 3 Trial to evaluate the Efficacy and Safety of Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comf...
    Medical condition: Moderate to Severe Vasomotor Symptoms (VMS) in Postmenopausal Women
    Disease: Version SOC Term Classification Code Term Level
    21.0 10047065 - Vascular disorders 10020407 Hot flashes LLT
    Population Age: Adults Gender: Female
    Trial protocol: PL (Completed) GB (GB - no longer in EU/EEA) SK (Completed) HU (Completed) LT (Completed) CZ (Completed) ES (Completed) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2015-003150-40 Sponsor Protocol Number: MIT-Es0001-C301 Start Date*: 2016-03-11
    Sponsor Name:Estetra SPRL
    Full Title: A Multicenter, Open-label, Single-Arm Study to Evaluate the Contraceptive Efficacy and Safety of a Combined Oral Contraceptive Containing 15 mg Estetrol and 3 mg Drospirenone
    Medical condition: Contraception
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10030970 Oral contraception PT
    Population Age: Adults Gender: Female
    Trial protocol: CZ (Completed) HU (Completed) SE (Completed) FI (Completed) PL (Completed) DE (Completed) BE (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri May 23 09:01:38 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA