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Clinical trials for Vaginal flora

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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    13 result(s) found for: Vaginal flora. Displaying page 1 of 1.
    EudraCT Number: 2019-002325-30 Sponsor Protocol Number: VMP-03/2018 Start Date*: 2019-09-18
    Sponsor Name:Dr. August Wolff GmbH & Co. KG Arzneimittel
    Full Title: Prospective, open-label, monocenter, trial to investigate the efficacy and tolerability of Vagisan® a lactic acid containing vaginal suppository, in a panel of post-menopausal women suffering from...
    Medical condition: vulvovaginal atrophy
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004872 10047782 Vulvovaginal atrophy LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-002918-12 Sponsor Protocol Number: 1-2013-HU Start Date*: Information not available in EudraCT
    Sponsor Name:Amvac Kft
    Full Title: Randomized, prospective, double blind clinical study to evaluate the effectiveness, dosage and safety of lactobacillus vaccine for management of bacterial vaginosis in a non-selected patient popula...
    Medical condition: Bacterial vaginosis (Nugent score 4 or above)
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: HU (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-002696-34 Sponsor Protocol Number: 150/2020 Start Date*: 2021-07-19
    Sponsor Name:University of Oulu
    Full Title: Prevention Of Group G/C Streptococcus Infections during labour and postpartum - a randomized controlled multicenter trial (POGSI)
    Medical condition: Participants are pregnant women found to carry group G or C Streptococcus as part of their vaginal-rectal flora in the late pregnancy vaginal-rectal culture routinely taken as GBS screening
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10004038 Bacterial infection due to streptococcus, group C LLT
    20.1 100000004862 10004040 Bacterial infection due to streptococcus, group G LLT
    Population Age: Adults Gender: Female
    Trial protocol: FI (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-003356-51 Sponsor Protocol Number: ZEL001 Start Date*: 2015-10-15
    Sponsor Name:Zelmic AB
    Full Title: A single-centre, open-label, single-arm, Phase I/II study to investigate the effect of a hydrogen peroxide foam on clinical signs and symptoms and the vaginal flora in patients with bacterial vagin...
    Medical condition: Bacterial vaginosis
    Disease: Version SOC Term Classification Code Term Level
    18.1 10021881 - Infections and infestations 10004055 Bacterial vaginosis PT
    Population Age: Adults Gender: Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-002199-28 Sponsor Protocol Number: VFCr-12/2015 Start Date*: 2016-10-11
    Sponsor Name:Dr. August Wolff GmbH & Co. KG Arzneimittel
    Full Title: Prospective, open-label, multicenter, multinational, randomized trial to investigate the non-inferiority of treatment with Vagisan® Moisturising Cream in comparison to an Estriol containing cream i...
    Medical condition: postmenopausal women suffering from symptoms of vulvovaginal dryness
    Disease: Version SOC Term Classification Code Term Level
    19.0 10038604 - Reproductive system and breast disorders 10047791 Vulvovaginal dryness PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-001759-22 Sponsor Protocol Number: PGX401-11 Start Date*: 2015-07-24
    Sponsor Name:Laboratoire Innotech International
    Full Title: Assessment of the efficacy of POLYGYNAX® in the empirical treatment of infectious vaginitis International, multicentre, randomised, double-blind, parallel group study, comparative versus miconazole
    Medical condition: Patients presenting with abnormal vaginal discharge associated with other vaginal symptoms (i.e. vaginal burning and/or vaginal irritation and/or vaginal pain) clinically evoking infectious vaginit...
    Disease: Version SOC Term Classification Code Term Level
    18.0 10021881 - Infections and infestations 10046950 Vaginitis LLT
    18.0 10021881 - Infections and infestations 10046914 Vaginal infection PT
    18.0 10021881 - Infections and infestations 10001107 Acute vaginitis LLT
    18.0 10021881 - Infections and infestations 10029562 Non-specific vaginitis LLT
    18.0 10021881 - Infections and infestations 10062167 Vaginitis bacterial PT
    Population Age: Adults Gender: Female
    Trial protocol: FR (Completed) CZ (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2016-002385-31 Sponsor Protocol Number: 2015/582 Start Date*: 2017-08-28
    Sponsor Name:Professor Peter Humaidan, The Fertility Clinic Skive
    Full Title: A double-blind, placebo-controlled multicenter trial on the effect of clindamycin and a live biotherapeutic on the reproductive outcomes of IVF patients with abnormal vaginal microbiota
    Medical condition: Infertility
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004865 10021572 In vitro fertilization LLT
    Population Age: Adults Gender: Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2019-002814-38 Sponsor Protocol Number: 69HCL18-0857 Start Date*: 2019-12-09
    Sponsor Name:Hospices Civils de Lyon
    Full Title: TROPHAMET, a phase I/II trial of Avelumab and METhotrexate in low-risk gestational TROPHoblastic neoplasias as first line treatment
    Medical condition: Low-risk gestational trophoblastic neoplasia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10018211 Gestational trophoblastic tumor NOS LLT
    Population Age: Adults Gender: Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-004268-21 Sponsor Protocol Number: ProF-001_Phase_IIa Start Date*: 2017-03-23
    Sponsor Name:Profem GmbH
    Full Title: A phase IIa randomized, active-controlled, double-blind, dose-escalation study in patients with vulvovaginal candidiasis to evaluate clinical efficacy, safety and tolerability and dose response rel...
    Medical condition: Vulvovaginal candidiasis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10047784 Vulvovaginal candidiasis PT
    Population Age: Adults Gender: Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2015-004563-37 Sponsor Protocol Number: IPR_GARDEFLORA_15-2 Start Date*: 2016-12-27
    Sponsor Name:Laboratoires IPRAD PHARMA
    Full Title: Study of the efficacy and safety of treatment with completely lyophilised cultures of Lactobacillus crispatus - IP 174178 administered intravaginally in the treatment of bacterial vaginosis.
    Medical condition: Bacterial vaginosis
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004862 10046960 Vaginosis bacterial LLT
    Population Age: Adults Gender: Female
    Trial protocol: PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-000925-27 Sponsor Protocol Number: ProF-001_Phase_IIb/III Start Date*: 2019-08-27
    Sponsor Name:Profem GmbH
    Full Title: A phase IIb/III, parallel-arm, randomized, active-controlled, double-blind, double-dummy, study in patients with recurrent vulvovaginal candidiasis to compare the clinical efficacy, safety and tole...
    Medical condition: recurrent vulvovaginal candidiasis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10047784 Vulvovaginal candidiasis PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: AT (Completed) SK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-004483-19 Sponsor Protocol Number: RRK5908 Start Date*: 2017-09-09
    Sponsor Name:University Hospitals Birmingham NHS Foundation Trust
    Full Title: A randomised controlled trial to assess the clinical and cost effectiveness of topical lactic acid gel for treating second and subsequent episodes of bacterial vaginosis
    Medical condition: Bacterial Vaginosis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10004055 Bacterial vaginosis PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-001472-22 Sponsor Protocol Number: IMUNOR-201501 Start Date*: 2017-03-14
    Sponsor Name:ImunomedicA, a.s.
    Full Title: A Prospective, Randomized, Double-Blind, Placebo-controlled, Multicenter, Phase III Study Assessing Efficacy and Safety of the IMUNOR® Therapy Versus Placebo in Patients with Recurrent Vulvovaginit...
    Medical condition: Recurrent vulvovaginitis episodes
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10047794 Vulvovaginitis PT
    Population Age: Adults Gender: Female
    Trial protocol: SK (Completed) CZ (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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