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    Clinical Trial Results:
    Tranexamic acid for the treatment of postpartum haemorrhage: An international randomised, double blind, placebo controlled trial

    Summary
    EudraCT number
    		 2008-008441-38
    Trial protocol
    		 GB  
    Global end of trial date
    16 Apr 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Nov 2018
    First version publication date
    03 Nov 2018
    Other versions
    Summary report(s)
    		 Final Results publication

    Trial information

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    Trial identification
    Sponsor protocol code
    ISRCTN76912190
    Additional study identifiers
    ISRCTN number
    		 ISRCTN76912190
    US NCT number
    		 NCT00872469
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    London School of Hygiene & Tropical Medicine
    Sponsor organisation address
    Keppel Street, London, United Kingdom, WC1E 7HT
    Public contact
    Haleema Shakur, Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK, 0207 9588113, thewomantrial@LSHTM.AC.UK
    Scientific contact
    Haleema Shakur, Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK, 0207 9588113, thewomantrial@LSHTM.AC.UK
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 Apr 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Apr 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Apr 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The WOMAN Trial aims to determine the effect of the early administration of tranexamic acid (TXA) on death and hysterectomy in women with a clinical diagnosis of postpartum haemorrhage.
    Protection of trial subjects
    The trial was done in accordance with the good clinical practice guidelines by the International Conference on Harmonisation. The procedure at each site was approved by the relevant ethics committee and regulatory agencies. Consent was obtained from women if their physical and mental capacity allowed (as judged by the treating clinician). If a woman was unable to give consent, proxy consent was obtained from a relative or representative. If a proxy was unavailable, then if permitted by local regulation, consent was deferred or waived. When consent was deferred or given by a proxy, the woman was informed about the trial as soon as possible, and consent was obtained for ongoing data collection, if needed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Mar 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 569
    Country: Number of subjects enrolled
    Albania: 485
    Country: Number of subjects enrolled
    Bangladesh: 325
    Country: Number of subjects enrolled
    Burkina Faso: 142
    Country: Number of subjects enrolled
    Cameroon: 893
    Country: Number of subjects enrolled
    Colombia: 8
    Country: Number of subjects enrolled
    Côte d’Ivoire: 8
    Country: Number of subjects enrolled
    Congo, The Democratic Republic of the: 457
    Country: Number of subjects enrolled
    Egypt: 33
    Country: Number of subjects enrolled
    Ethiopia: 302
    Country: Number of subjects enrolled
    Ghana: 41
    Country: Number of subjects enrolled
    Jamaica: 73
    Country: Number of subjects enrolled
    Kenya: 1031
    Country: Number of subjects enrolled
    Nepal: 533
    Country: Number of subjects enrolled
    Nigeria: 5711
    Country: Number of subjects enrolled
    Pakistan: 5282
    Country: Number of subjects enrolled
    Papua New Guinea: 38
    Country: Number of subjects enrolled
    Sudan: 860
    Country: Number of subjects enrolled
    Tanzania, United Republic of: 538
    Country: Number of subjects enrolled
    Uganda: 2235
    Country: Number of subjects enrolled
    Zambia: 496
    Worldwide total number of subjects
    20060
    EEA total number of subjects
    569
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    54
    Adults (18-64 years)
    20006
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The WOMAN trial randomisedwomen aged 16 years and older with a clinical diagnosis of post-partum haemorrhage after a vaginal birth or caesarean section done in 193 hospitals in 21 countries. The first patient was randomised on 22/03/2010 and the final patient on 16/04/2016.

    Pre-assignment
    Screening details
    		 All legally adult women with clinically diagnosed of postpartum haemorrhage (PPH) following vaginal delivery or caesarean section are considered eligible for the trial. The fundamental eligibility criterion is the responsible clinician’s ‘uncertainty’ as to whether or not to use an antifibrinolytic agent in a particular woman with PPH.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor
    Blinding implementation details
    Ampoules and packaging for tranexamic acid (TXA) and placebo were identical in appearance. The masking involved the removal of the original manufacturer’s label and replacement with the clinical trial label bearing the randomisation number, which was used as the pack identification. Patients were randomly allocated to receive TXA or placebo. The randomisation codes were generated and held by an independent statistical consultant.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tranexamic Acid
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cyklokapron
    Investigational medicinal product code
    BO2AA02
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were randomly allocated to receive 1 g tranexamic acid or placebo by slow intravenous injection. Investigators were advised to give 1 g (10 mg/mL) of tranexamic acid intravenously at an approximate rate of 1 mL per min. If bleeding continued after 30 min or stopped and restarted within 24 h of the first dose, a second dose of 1 g of tranexamic acid or placebo could be given.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Sodium chloride 0·9%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were randomly allocated to receive 1 g tranexamic acid or placebo by slow intravenous injection. Investigators were advised to give 1 g (10 mg/mL) of tranexamic acid intravenously at an approximate rate of 1 mL per min. If bleeding continued after 30 min or stopped and restarted within 24 h of the first dose, a second dose of 1 g of tranexamic acid or placebo could be given.

    Number of subjects in period 1
    		Tranexamic Acid Placebo
    Started
    10051
    10009
    Completed
    10036
    9985
    Not completed
    15
    24
         Consent withdrawn by subject
    4
    3
         Lost to follow-up
    11
    21

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tranexamic Acid
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Tranexamic Acid Placebo Total
    Number of subjects
    		 10051 10009 20060
    Age categorical
    Units: Subjects
        <16
    		 1 3 4
        16-25
    		 3445 3407 6852
        26-33
    		 4580 4608 9188
        >=34
    		 2022 1987 4009
        Unknown
    		 3 4 7
    Gender categorical
    All participants in this study were women
    Units: Subjects
        Female
    		 10051 10009 20060
    Baby delivered in the randomising hospital
    Units: Subjects
        Yes
    		 8869 8756 17625
        No
    		 1181 1251 2432
        Unknown
    		 1 2 3
    Type of delivery
    Units: Subjects
        Vaginal
    		 7093 7126 14219
        Caesarean section
    		 2957 2879 5836
        Unknown
    		 1 4 5
    Time between delivery and randomisation (h)
    Units: Subjects
        ≤1
    		 4852 4733 9585
        >1 to ≤3
    		 2678 2691 5369
        >3
    		 2517 2574 5091
        Unknown
    		 4 11 15
    Primary cause of haemorrhage
    Units: Subjects
        Uterine atony
    		 6437 6347 12784
        Placenta praevia or accreta
    		 943 935 1878
        Surgical trauma or tears
    		 1834 1857 3691
        Other
    		 720 737 1457
        Unknown
    		 117 133 250
    Systolic blood pressure (mm Hg)
    Units: Subjects
        ≥90
    		 8138 8065 16203
        <90
    		 1908 1929 3837
        Unknown
    		 5 15 20
    Estimated volume of blood lost (mL)
    Units: Subjects
        ≤500
    		 295 313 608
        >500 to ≤1000
    		 4949 4861 9810
        >1000 to ≤1500
    		 2832 2882 5714
        >1500
    		 1973 1953 3926
        Unknown
    		 2 0 2
    Uterotonic prophylaxis given
    Units: Subjects
        Yes
    		 9687 9618 19305
        No
    		 131 139 270
        Unknown
    		 233 252 485

    End points

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    End points reporting groups
    Reporting group title
    Tranexamic Acid
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Effect of tranexamic acid on maternal death

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    End point title
    		 Effect of tranexamic acid on maternal death
    End point description
    End point type
    Primary
    End point timeframe
    x
    End point values
    		 Tranexamic Acid Placebo
    Number of subjects analysed
    10036
    9985
    Units: Dead or alive
        Bleeding
    155
    191
        Pulmonary embolism
    10
    11
        Organ failure
    25
    18
        Sepsis
    15
    8
        Eclampsia
    2
    8
        Other
    20
    20
        Any cause of death
    227
    256
    Attachments
    		 Effect of tranexmaic acid on maternal death
    Death from bleeding by subgroup
    Statistical analysis title
    		 WOMAN Trial
    Comparison groups
    Tranexamic Acid v Placebo
    Number of subjects included in analysis
    20021
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Parameter type
    		 Risk ratio (RR)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Any suspected unexpected serious adverse reaction that occurs during hospitalisation or any untoward medical occurrence after discharge and up to 42 days after the trial treatment has been given must be logged with the Coordinating Centre 24 hours.
    Adverse event reporting additional description
    Prior to discharge, all randomised women will be given a (supplied) alert card, so either a woman or her family can present the card to any healthcare provider she sees after she is discharged. Also, a post discharge form which gives details of the woman and the contact details of the WOMAN trial PI were kept in the women's records.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27
    Reporting groups
    Reporting group title
    Tranexamic Acid
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Tranexamic Acid Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 10029 (0.15%)
    11 / 9979 (0.11%)
         number of deaths (all causes)
    227
    256
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Transfusion reaction
         subjects affected / exposed
    3 / 10029 (0.03%)
    0 / 9979 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bleeding from caesarian section site
         subjects affected / exposed
    0 / 10029 (0.00%)
    1 / 9979 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    1 / 10029 (0.01%)
    0 / 9979 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Eclampsia
         subjects affected / exposed
    0 / 10029 (0.00%)
    1 / 9979 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 10029 (0.00%)
    1 / 9979 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incontinence
         subjects affected / exposed
    1 / 10029 (0.01%)
    0 / 9979 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papilloedema
    Additional description: Secondary to pre-eclampsia
         subjects affected / exposed
    0 / 10029 (0.00%)
    1 / 9979 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retained products of conception
         subjects affected / exposed
    0 / 10029 (0.00%)
    1 / 9979 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Secondary postpartum haemorrhage
         subjects affected / exposed
    3 / 10029 (0.03%)
    2 / 9979 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal bleeding
         subjects affected / exposed
    1 / 10029 (0.01%)
    1 / 9979 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 10029 (0.01%)
    0 / 9979 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
    Additional description: Postpartum
         subjects affected / exposed
    1 / 10029 (0.01%)
    0 / 9979 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombotic thrombocytopenic purpura
         subjects affected / exposed
    1 / 10029 (0.01%)
    0 / 9979 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Jaundice
         subjects affected / exposed
    0 / 10029 (0.00%)
    1 / 9979 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
    Additional description: due to psammocarcinoma
         subjects affected / exposed
    1 / 10029 (0.01%)
    0 / 9979 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Vesicovaginal fistula
         subjects affected / exposed
    1 / 10029 (0.01%)
    0 / 9979 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary thrombosis
         subjects affected / exposed
    1 / 10029 (0.01%)
    1 / 9979 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
    Additional description: Palpatations and fainting
         subjects affected / exposed
    0 / 10029 (0.00%)
    1 / 9979 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary retention
    Additional description: Due to psammocarcinoma
         subjects affected / exposed
    1 / 10029 (0.01%)
    0 / 9979 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Endometritis
         subjects affected / exposed
    1 / 10029 (0.01%)
    1 / 9979 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 10029 (0.00%)
    1 / 9979 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound sepsis
         subjects affected / exposed
    1 / 10029 (0.01%)
    0 / 9979 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Tranexamic Acid Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 10029 (0.12%)
    14 / 9979 (0.14%)
    Vascular disorders
    Bleeding
         subjects affected / exposed
    1 / 10029 (0.01%)
    1 / 9979 (0.01%)
         occurrences all number
    1
    1
    Haematoma
         subjects affected / exposed
    1 / 10029 (0.01%)
    0 / 9979 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia, postpartum
         subjects affected / exposed
    1 / 10029 (0.01%)
    2 / 9979 (0.02%)
         occurrences all number
    1
    2
    Transfusion reaction
         subjects affected / exposed
    0 / 10029 (0.00%)
    1 / 9979 (0.01%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Swelling
         subjects affected / exposed
    0 / 10029 (0.00%)
    1 / 9979 (0.01%)
         occurrences all number
    0
    1
    Immune system disorders
    Allergic reaction
         subjects affected / exposed
    0 / 10029 (0.00%)
    1 / 9979 (0.01%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 10029 (0.01%)
    0 / 9979 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Dysfunctional uterine bleeding
         subjects affected / exposed
    0 / 10029 (0.00%)
    1 / 9979 (0.01%)
         occurrences all number
    0
    1
    Vaginal Bleeding
         subjects affected / exposed
    0 / 10029 (0.00%)
    1 / 9979 (0.01%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Allergy rash
         subjects affected / exposed
    1 / 10029 (0.01%)
    0 / 9979 (0.00%)
         occurrences all number
    1
    0
    Urticaria rash
         subjects affected / exposed
    0 / 10029 (0.00%)
    1 / 9979 (0.01%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Urinary Retention
         subjects affected / exposed
    1 / 10029 (0.01%)
    1 / 9979 (0.01%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    Muscular-skeletal pain
         subjects affected / exposed
    1 / 10029 (0.01%)
    0 / 9979 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Malaria
         subjects affected / exposed
    0 / 10029 (0.00%)
    1 / 9979 (0.01%)
         occurrences all number
    0
    1
    Perineal infection
         subjects affected / exposed
    0 / 10029 (0.00%)
    1 / 9979 (0.01%)
         occurrences all number
    0
    1
    Urinary Tract Infection
         subjects affected / exposed
    2 / 10029 (0.02%)
    2 / 9979 (0.02%)
         occurrences all number
    2
    2
    Vaginal infection
         subjects affected / exposed
    1 / 10029 (0.01%)
    0 / 9979 (0.00%)
         occurrences all number
    1
    0
    Wound infection
         subjects affected / exposed
    1 / 10029 (0.01%)
    1 / 9979 (0.01%)
         occurrences all number
    1
    1
    Metabolism and nutrition disorders
    Hypoglycaemic event
         subjects affected / exposed
    1 / 10029 (0.01%)
    0 / 9979 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Jan 2014
    As of December 2013, the trial had recruited 10,014 women, 261 of whom died. Because the effect of tranexamic acid on maternal mortality is of considerable public health importance, the sample size was increased from 15,000 to 20,000 so that the trial has enough power to detect an effect on this important secondary outcome. This involved an additional 15 months of recruitment. On this basis, the Trial Protocol Version 1.0, dated 11 May 2009, was modified as follows: • Increase the sample size from 15,000 to 20,000 • Date of last patient recruitment: changes from 31 December 2014 to 31 March 2016 • Date of last patient follow up: changes from 11 February 2015 to 12 May 2016

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28456509
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