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Clinical trials for Dienogest

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   44346   clinical trials with a EudraCT protocol, of which   7374   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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    18 result(s) found for: Dienogest. Displaying page 1 of 1.
    EudraCT Number: 2010-018590-38 Sponsor Protocol Number: 70421 Start Date*: 2010-04-14
    Sponsor Name:LUMC
    Full Title: The thrombogenicity of the dienogest/estradiol valerate containing oral contraceptive (Qlaira)
    Medical condition: We will investigate the thrombogenicity of two different oral contraceptives: dienogest/estradiol valerate (Qlaira) in comparison to levonorgestrel/ethinylestradiol (Microgynon-30) used by healthy ...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10030971 Oral contraceptive LLT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-006633-41 Sponsor Protocol Number: 310723 Start Date*: 2007-04-11
    Sponsor Name:Bayer Schering Pharma AG
    Full Title: Monocenter, open-label, randomized study to determine the ovulation inhibitory effect of the combined oral contraceptives SH T04769G (0.015 mg Ethinylestradiol and 1.5 mg Dienogest in a modified re...
    Medical condition: The aim of this monocenter, open-label, randomized study is to determine the ovulation inhibitory effect of the COC SH T04769G (0.15 mg Ethinylestradiol and 1.5 mg Dienogest in a modified release f...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10030970 Oral contraception LLT
    Population Age: Adults Gender: Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-017169-53 Sponsor Protocol Number: BAY86-5258/13788 Start Date*: 2011-01-17
    Sponsor Name:Bayer HelathCare AG
    Full Title: Estudio multicéntrico, abierto, de un brazo de tratamiento para evaluar la seguridad y la eficacia de la administración oral diaria de 2 mg de Dienogest en el tratamiento de la endometriosis en ado...
    Medical condition: Sospecha clínica o confirmada de endometriosis en mujeres adolescentes post-menarquia de 12 a menos de 18 años de edad (Clinically suspected or confirmed endometriosis in post menarche female adole...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10014778 Endometriosis LLT
    Population Age: Adolescents, Under 18 Gender: Female
    Trial protocol: ES (Completed) FI (Completed) DE (Completed) AT (Completed) FR (Completed) CZ (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: 2005-004340-32 Sponsor Protocol Number: 308961 Start Date*: 2006-04-20
    Sponsor Name:Bayer Schering Pharma AG
    Full Title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, 7 Cycle Duration (196 Days), Phase 3 Study of Oral Estradiol Valerate/Dienogest Tablets for the Treatment of Dysfunction...
    Medical condition: Treatment of prolonged, excessive or frequent bleeding in women without organic pathology who desire oral contraception.
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (Completed) SE (Completed) DE (Completed) FI (Completed) HU (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2016-003831-39 Sponsor Protocol Number: LPRI421-202 Start Date*: 2017-03-31
    Sponsor Name:Exeltis France S.A.
    Full Title: Multicentre, phase II, open label randomised clinical trial to assess the bleeding profile, tolerability and safety associated with the use of three prolonged release formulations containing a comb...
    Medical condition: Oral contraception for females aged 18-35
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10042613 Surgical and medical procedures SOC
    20.0 10042613 - Surgical and medical procedures 10030970 Oral contraception PT
    Population Age: Adults Gender: Female
    Trial protocol: LT (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2004-001614-13 Sponsor Protocol Number: 301886 Start Date*: 2005-06-08
    Sponsor Name:Schering AG
    Full Title: A single-center, open-label, controlled, randomized study to investigate the impact of a sequential oral contraceptive containing estradiol valerate and dienogest (SH T00658ID) as compared to a seq...
    Medical condition: Contraception
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2004-001613-34 Sponsor Protocol Number: 304004 Start Date*: 2005-02-01
    Sponsor Name:Schering AG
    Full Title: A multi-center, double-blind, double-dummy, controlled, randomized study to evaluate cycle control and safety of a four-phasic oral contraceptive containing estradiol valerate and dienogest (SH T00...
    Medical condition: Contraception
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: DE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2019-001876-12 Sponsor Protocol Number: LPRI-424/301 Start Date*: 2019-12-16
    Sponsor Name:Chemo Research S.L.
    Full Title: A multicentre, uncontrolled trial on the contraceptive efficacy, safety, tolerability and pharmacokinetics of LPRI-424 (dienogest 2 mg / ethinyl estradiol 0.02 mg) during 13 cycles
    Medical condition: Oral contraception for females aged 18-45
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10042613 Surgical and medical procedures SOC
    21.1 10042613 - Surgical and medical procedures 10030970 Oral contraception PT
    Population Age: Adults Gender: Female
    Trial protocol: DE (Completed) LT (Completed) PT (Not Authorised) ES (Completed) BG (Completed) CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-003226-42 Sponsor Protocol Number: 91550 Start Date*: 2008-12-10
    Sponsor Name:Bayer HealthCare AG
    Full Title: A multicenter, randomized, double-blind, active-controlled, parallel group, 2-arm study to investigate the effect of estradiol valerate/dienogest compared to Microgynon on hormone withdrawal associ...
    Medical condition: Hormone withdrawal associated symptoms of headache and pelvic pain suffered by patients receiving LNG containing oral contraception.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10030970 Oral contraception LLT
    Population Age: Adults Gender: Female
    Trial protocol: FI (Completed) DE (Completed) ES (Completed) GB (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2008-002263-13 Sponsor Protocol Number: 91548 Start Date*: 2009-03-13
    Sponsor Name:Bayer HealthCare AG
    Full Title: Multi-center, double-blind, randomized study to investigate the impact of a sequential oral contraceptive containing estradiol valerate and dienogest (SH T00658ID) compared to a monophasic contrace...
    Medical condition: Reduced libido in women with acquired female sexual dysfunction (FSD) associated with oral contraceptive use.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10030970 Oral contraception LLT
    Population Age: Adults Gender: Female
    Trial protocol: AT (Completed) DE (Completed) BE (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-003830-26 Sponsor Protocol Number: LPRI-421/201 Start Date*: 2017-02-24
    Sponsor Name:Exeltis France
    Full Title: Single center, phase II, open label randomized clinical trial to evaluate the inhibition of ovulation of three prolonged release formulations containing a combination of Dienogest and Ethinyl Estra...
    Medical condition: Women’s healthcare (contraception, inhibition of ovulation).
    Disease: Version SOC Term Classification Code Term Level
    19.1 10042613 - Surgical and medical procedures 10010808 Contraception PT
    Population Age: Adults Gender: Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-000041-12 Sponsor Protocol Number: 49/11/EDG/TP2 Start Date*: 2012-03-23
    Sponsor Name:Zentiva k.s. Prague
    Full Title: Characterisation of ovulation inhibition and effects on metabolic parameters and haemostatic system of multiple administrations of a fixed-dose combination product containing 0.02 mg ethinylestradi...
    Medical condition: Investigation of ovulation inhibition, effects on metabolic parameters and haemostatic system for indication of contraception
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10030970 Oral contraception PT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2019-001877-97 Sponsor Protocol Number: LPRI-424/302 Start Date*: 2020-02-19
    Sponsor Name:Chemo Research S.L.
    Full Title: A multicentre, double-blind, double-dummy, randomised trial on the contraceptive efficacy, tolerability and safety of LPRI-424 (dienogest 2 mg / ethinyl estradiol 0.02 mg) during nine cycles in com...
    Medical condition: Oral contraception for females aged 18-45
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10042613 Surgical and medical procedures SOC
    21.1 10042613 - Surgical and medical procedures 10030970 Oral contraception PT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Completed) CZ (Completed) SK (Completed) HU (Completed) PT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-005005-28 Sponsor Protocol Number: ADENOFERT Start Date*: 2022-11-08
    Sponsor Name:AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA
    Full Title: Assisted reproductive technology (ART) and pregnancy outcomes in women with adenomyosis (internal endometriosis) according to stimulation protocol in relation to immunological and endometrial featu...
    Medical condition: Women with transvaginal ultrasound (TV-US)-based diagnosis of adenomyosis and women without adenomyosis but with similar baseline reproductive risks
    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: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-002178-17 Sponsor Protocol Number: LPRI-424/304 Start Date*: 2021-09-27
    Sponsor Name:Chemo Research S.L.
    Full Title: A multicentre, phase III, double-blind, randomised clinical trial to assess the efficacy and safety of LPRI-424 (dienogest 2.00 mg / ethinyl estradiol 0.02 mg) in the treatment of polycystic ovary ...
    Medical condition: Hirsutism related to Polycystic Ovarian Syndrome
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038604 - Reproductive system and breast disorders 10036049 Polycystic ovaries PT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: PL (Completed) ES (Completed) CZ (Completed) LT (Completed) SK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-004184-36 Sponsor Protocol Number: UKER-AN-HS-01 Start Date*: 2016-01-05
    Sponsor Name:Universitätsklinikum Erlangen
    Full Title: Prospective, randomised, double-blind, placebo-controlled, single centre phase IIa clinical trial to investigate the safety and tolerability as well as the impact of a substitution of sexual hormon...
    Medical condition: Substitution of sexual hormones in adult females with anorexia nervosa
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004865 10063915 Substitution therapy LLT
    Population Age: Adults Gender: Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-005625-11 Sponsor Protocol Number: DC00050/91781 Start Date*: 2009-09-08
    Sponsor Name:Bayer Healthcare AG
    Full Title: A multi-center, double-blind, double-dummy, randomized, controlled, parallel-group study to assess efficacy and safety of SH T00658ID compared to SH D593B in the treatment of primary dysmenorrhea
    Medical condition: Primary dysmenorrhea in women requesting oral contraception
    Disease: Version SOC Term Classification Code Term Level
    9.1 10030970 Oral contraception LLT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: DE (Completed) IT (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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