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Clinical trials for Drospirenone

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
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    • 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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    41 result(s) found for: Drospirenone. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2007-005258-22 Sponsor Protocol Number: 311926 Start Date*: 2008-02-26
    Sponsor Name:Bayer Schering Pharma AG
    Full Title: A multi-center, double-blind, randomized, parallel-group study to evaluate cycle control and safety of 6 different regimens of an oral contraceptive containing estradiol and drospirenone in healthy...
    Medical condition: The trial will be performed in healthy female volunteers. The intended indication is female contraception.
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-004544-73 Sponsor Protocol Number: 311623 Start Date*: 2008-01-23
    Sponsor Name:Bayer Schering Pharma AG
    Full Title: A double-blind, randomized, uncontrolled study to evaluate inhibition of ovulation of two oral estradiol / drospirenone regimens in healthy young female volunteers over a period of 3 treatment cycles
    Medical condition: The trial will be performed in healthy female volunteers. The intended indication is female contraception.
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-002300-13 Sponsor Protocol Number: CCR13001,CF111/205 Start Date*: 2013-11-05
    Sponsor Name:CHEMO France
    Full Title: A study to evaluate the effect on the endometrium of a new formulation containing 4 mg drospirenone (Drospirenone 4 mg film-coated tablet) administered over a period of 13 cycles. A monocentric, op...
    Medical condition: Assessing the endometrial safety of an oral test preparation containing 4 mg drospirenone, which is usually used as contraceptive.
    Disease: Version SOC Term Classification Code Term Level
    16.0 10042613 - Surgical and medical procedures 10030970 Oral contraception PT
    Population Age: Adults Gender: Female
    Trial protocol: BG (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: 2011-004085-15 Sponsor Protocol Number: CF111/203 Start Date*: 2011-11-04
    Sponsor Name:Laboratories León Farma S.A
    Full Title: Open-Label, Randomized Study to Evaluate the Influence on the Hormonal and Ovarian Activity of Two Different Dosages of Drospirenone (either 4.0 mg for 24 Days or 2.8 mg Daily for 28 Days) Over Two...
    Medical condition: Evaluation of the influence of Drosperinone on the hormonal and ovarian activity, the bleeding pattern and the endometrial thickness.
    Disease: Version SOC Term Classification Code Term Level
    14.0 10042613 - Surgical and medical procedures 10030970 Oral contraception PT
    Population Age: Adults Gender: Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-005234-37 Sponsor Protocol Number: CF111/304 Start Date*: 2014-05-28
    Sponsor Name:Laboratorios León Farma S.A.
    Full Title: Multicentre, Open-Label Trial to Assess the Safety and Tolerability of LF111 (Drospirenone 4.0 mg) Over 6 Cycles in Female Adolescents, With a 7-Cycle Extension Phase
    Medical condition: Oral contraception for postmenarcheal female adolescents, with or without intact hymen, aged 14-17 and without uncontrolled concomitant disease.
    Disease: Version SOC Term Classification Code Term Level
    18.1 10042613 - Surgical and medical procedures 10030970 Oral contraception PT
    Population Age: Adolescents, Under 18 Gender: Female
    Trial protocol: DE (Completed) NL (Not Authorised) FI (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2013-001513-33 Sponsor Protocol Number: CF111/204 Start Date*: 2013-06-04
    Sponsor Name:Laboratorios León Farma S.A.
    Full Title: Phase II trial to evaluate the maintenance of ovulation inhibition with LF111 (drospirenone 4.0 mg 24/4 regimen) after scheduled 24-hour delays in pill intake.
    Medical condition: Evaluation of ovulation inhibition with scheduled 24h delay in pill intake in healty young females of child bearing potential.
    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: DE (Completed)
    Trial results: View results
    EudraCT Number: 2006-004899-13 Sponsor Protocol Number: 310882 Start Date*: 2008-01-16
    Sponsor Name:Bayer Schering Pharma AG
    Full Title: A multi-center, open-label, randomized, controlled, parallel-group study to assess efficacy and safety of an extended flexible regimen of the combined oral contraceptive SH T00186D (0.02 mg ethinyl...
    Medical condition: women suffering from primary dysmenorrhea
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-000412-30 Sponsor Protocol Number: LF111/401 Start Date*: Information not available in EudraCT
    Sponsor Name:Chemo Research S.L.
    Full Title: A multicenter, open-label, controlled study to investigate the effect of either LF111 or Drospirenone chewable tablets on bone mineral density (BMD) in adolescent and adult women in comparison with...
    Medical condition: Oral contraception
    Disease: Version SOC Term Classification Code Term Level
    21.0 10022891 - Investigations 10049470 Bone density decreased PT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: CZ (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-021787-15 Sponsor Protocol Number: CF111/301 Start Date*: 2011-03-23
    Sponsor Name:Laboratorios León Farma S.A.
    Full Title: A Pivotal, Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety and Tolerability of Drospirenone as LF111 During 13 Cycles
    Medical condition: Oral hormonal contraceptive for women without uncontrolled current diseases between 18-45 years.
    Disease: Version SOC Term Classification Code Term Level
    13.1 10042613 - Surgical and medical procedures 10010808 Contraception PT
    Population Age: Adults Gender: Female
    Trial protocol: DE (Completed) HU (Completed) CZ (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2011-002396-42 Sponsor Protocol Number: CF111/302 Start Date*: 2012-02-09
    Sponsor Name:Laboratorios León Farma S.A.
    Full Title: A Pivotal, Multicentre, Double-Blind, Double-Dummy, Randomised Trial on the Contraceptive Efficacy, Tolerability and Safety of LF111 (Drospirenone) Over 9 Cycles in Comparison With Desogestrel 0.07...
    Medical condition: Oral hormonal contraceptive for women without uncontrolled current diseases between 18-45 years.
    Disease: Version SOC Term Classification Code Term Level
    15.1 10042613 - Surgical and medical procedures 10030970 Oral contraception PT
    Population Age: Adults Gender: Female
    Trial protocol: DE (Completed) HU (Completed) CZ (Completed) AT (Completed) ES (Completed) SK (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: 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: 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: 2006-001546-14 Sponsor Protocol Number: 292003 Start Date*: 2006-08-30
    Sponsor Name:NV Organon
    Full Title: A randomized, open-label, comparative trial to evaluate the effects on ovarian function of a monophasic combined oral contraceptive (COC) containing 2.5 mg nomegestrol acetate (NOMAC) and 1.5 mg es...
    Medical condition: Hormonal oral contraception in healthy women
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2005-005304-16 Sponsor Protocol Number: 292001 Start Date*: 2006-06-09
    Sponsor Name:NV Organon
    Full Title: A randomized, open-label, comparative, multi-center trial to evaluate contraceptive efficacy, cycle control, safety and acceptability of a monophasic combined oral contraceptive (COC) containing 2....
    Medical condition: Hormonal oral contraception in healthy women
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed) SE (Completed) DK (Completed) FI (Completed) BE (Completed) DE (Completed) ES (Completed) CZ (Completed) GB (Completed) IT (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2021-001424-17 Sponsor Protocol Number: CF113-302 Start Date*: 2021-10-11
    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-CF113 in the treatment of endometriosis versus placebo after 3 medication cycles followed...
    Medical condition: Endometriosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038604 - Reproductive system and breast disorders 10014778 Endometriosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: DE (Completed) SK (Completed) CZ (Completed) LT (Completed) PL (Completed) HU (Completed) BE (Completed) ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-003661-19 Sponsor Protocol Number: AGO/2008/007 Start Date*: 2009-06-26
    Sponsor Name:University Hospital Ghent
    Full Title: Invloed van laag gedoseerde hormonale substitutie op insulinespiegels bij postmenopausale vrouwen
    Medical condition: Postmenopausale vrouwen
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-024546-30 Sponsor Protocol Number: CF111/202 Start Date*: 2012-02-10
    Sponsor Name:Laboratories León Farma S.A.
    Full Title: Randomized, Open-Label Study to Evaluate the Influence on the Ovarian Activity, and the Cervix Score Over Two Treatment Cycles of 4.0 mg Drospirenone Daily for 24 Days as Compared to 0.075 mg Desog...
    Medical condition: Evaluation of the influence on the ovarian activity, the cervix score, the bleeding pattern and the endometrial thickness in healthy young females.
    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: DE (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
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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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