Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Atosiban

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   44336   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 ).  
     
    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: Atosiban. Displaying page 1 of 1.
    EudraCT Number: 2017-001007-72 Sponsor Protocol Number: 80-84800-98-41027 Start Date*: 2017-07-06
    Sponsor Name:Amsterdam UMC location AMC
    Full Title: Atosiban versus placebo in the treatment of late threatened preterm birth (APOSTEL VIII).
    Medical condition: Neonatal outcome in threatened preterm birth between 30 and 34 weeks of gestation.
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2007-003158-27 Sponsor Protocol Number: FE 200440 CS09 Start Date*: 2007-09-20
    Sponsor Name:Ferring Pharmaceuticals A/S
    Full Title: A randomised, double-blind, parallel groups, placebo-controlled, multi-centre study assessing the effects of a selective oxytocin antagonist (barusiban) and a mixed oxytocin antagonist – vasopressi...
    Medical condition: Co-adjuvant therapy in the luteal phase to facilitate implantation and pregnancy in women undergoing assisted reproductive technologies (i.e. IVF/ICSI with embryo transfer)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10061400 Uterine contractions abnormal LLT
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed) PL (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2013-002561-19 Sponsor Protocol Number: 1 Start Date*: 2014-03-06
    Sponsor Name:Medizinische Universität Wien, Univ.Klinik f.Frauenheilkunde,Abt. f.Geburtshilfe und Feto-maternale Medizin
    Full Title: A prospective, double blind, randomised, placebo controlled trial to evaluate the effect of a long term tokolysis with atosiban on the pregnancy outcome. A pilot study.
    Medical condition: Premature uterine contractions premature labor
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004868 10068718 Premature uterine contractions LLT
    16.1 100000004868 10036599 Premature labor LLT
    Population Age: Adults Gender: Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-001826-13 Sponsor Protocol Number: 200721 Start Date*: 2015-02-16
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: Randomized, Double-blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban Therapy for Women in Spontaneous Preterm Labor
    Medical condition: preterm labor
    Disease: Version SOC Term Classification Code Term Level
    19.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036595 Premature delivery PT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: BE (Completed) GB (Completed) SE (Completed) ES (Completed) DE (Completed) IT (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2017-002579-25 Sponsor Protocol Number: 17-OBE022-003 Start Date*: 2017-10-31
    Sponsor Name:ObsEva SA
    Full Title: A phase 2a, double-blind, parallel group, randomised, placebo controlled, proof of concept study to assess the efficacy, safety and pharmacokinetics of OBE022 added-on to atosiban, after oral admin...
    Medical condition: oral treatment of threatened spontaneous preterm labour in weeks 24 to 34 of pregnancy
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004868 10075863 Preterm labor LLT
    Population Age: Adults Gender: Female
    Trial protocol: FI (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-015782-30 Sponsor Protocol Number: APOSTELIII Start Date*: 2012-11-23
    Sponsor Name:Academic Medical Centre
    Full Title: Nifedipine versus Atosiban in the treatment of threatened preterm labour
    Medical condition: Threatened preterm labour
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004868 10056173 Threatened premature labour, antepartum LLT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-007344-34 Sponsor Protocol Number: 01-11-2008 Start Date*: 2009-08-03
    Sponsor Name:Academic Medical Centre
    Full Title: External Cephalic Version with uterine relaxation: atosiban versus fenoterol, a multi-centre trial
    Medical condition: ECV of the fetus in breech position is a safe and relatively simple obstetrical intervention that reduces the incidence of caesarean section for breech position at term. Tocolysis can enhance the s...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10006356 Breech presentation LLT
    9.1 10006356 Breech presentation LLT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-003603-61 Sponsor Protocol Number: 002 Start Date*: 2017-07-19
    Sponsor Name:
    Full Title: Clinical trial on the administration of 3 doses of betamethasone (12 mg) in 18 hours apart in twin pregnancy patients with threatened preterm birth treated by Atosiban, rather than 2 doses of betam...
    Medical condition: Premature delivery in twin pregnancies
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004868 10028244 Multiple pregnancy affecting fetus or newborn LLT
    19.1 100000004868 10036564 Pregnancy multiple LLT
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-002547-15 Sponsor Protocol Number: UTM/2012 Start Date*: 2012-11-13
    Sponsor Name:Instituto de Investigacion Sanitaria La Fe
    Full Title: UTILITY OF THE ocolytict MAINTENANCE TREATMENT IN THE MANAGEMENT OF THE THREAT OF PREMATURE
    Medical condition: Threat Preterm labor
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2009-010759-29 Sponsor Protocol Number: 001 Start Date*: 2009-04-27
    Sponsor Name:Cliniques Universitaires Saint-Luc
    Full Title: étude clinique sur l’administration de 3 doses de betaméthasone (12mg) à 18 heures d’intervalle lors d’une menace d’accouchement prématuré dans les grossesses gémellaires traitées par Atosiban, plu...
    Medical condition: Premature delivery in twin pregnancies
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036564 Pregnancy multiple LLT
    9.1 10028244 Multiple pregnancy affecting fetus or newborn LLT
    Population Age: In utero, Under 18, Adults Gender: Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2014-000499-24 Sponsor Protocol Number: 200722 Start Date*: 2015-02-16
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: Follow-Up Study to Assess Long-Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies
    Medical condition: preterm labour and improve neonatal health
    Disease: Version SOC Term Classification Code Term Level
    20.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036595 Premature delivery PT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) ES (Completed) SE (Completed) DE (Completed) IT (Completed) FR (Ongoing)
    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-Mon May 19 15:30:06 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA