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    Clinical Trial Results:
    Efficacy of oral nifedipine, naproxen, or placebo for pain relief during diagnostic hysteroscopy in an office setting: a randomized pilot study

    Summary
    EudraCT number
    		 2018-001020-19
    Trial protocol
    		 BE  
    Global end of trial date
    01 Dec 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jun 2024
    First version publication date
    07 Jun 2024
    Other versions
    Summary report(s)
    		 Protocol
    Published Article

    Trial information

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    Trial identification
    Sponsor protocol code
    NL65360.18
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Dutch Clinical Trial Registry : NL7750
    Sponsors
    Sponsor organisation name
    UZ Ghent
    Sponsor organisation address
    C. Heymanslaan 10, Gent, Belgium, 9000
    Public contact
    HIRUZ, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
    Scientific contact
    HIRUZ, Ghent University Hospital, 093320000 93320500, hiruz.ctu@uzgent.be
    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
    29 Sep 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jun 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Dec 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study is to compare the pain intensity during hysteroscopy after using nifedipine as pain medication versus using naproxen or placebo.
    Protection of trial subjects
    - Blood pressure registration before and after treatment allocation - Medication related side-effects were administered until the day after treatment allocation
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 59
    Country: Number of subjects enrolled
    Netherlands: 1
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    0
    Adults (18-64 years)
    60
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This research will examine healthy women scheduled for a hysteroscopy.

    Pre-assignment
    Screening details
    		 In order to be eligible to participate in this study, a subject must meet all of the following criteria: at least 18 years of age, no medical history of cardiovascular disease, no hypotension; baseline blood pressure greater than or equal to 120/60 mmHg, otherwise healthy women with an average BMI (BMI<30), scheduled for a diagnostic hysteroscopy i

    Period 1
    Period 1 title
    Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Single blind [1]
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Frist group
    Arm description
    		 A multicentre single-blinded pilot study with a naproxen and placebo controlled, randomized study design. We will include 60 women at each side, scheduled for a hysteroscopy. One group will receive two 10 mg capsules short-acting Nifedipine® 60-30 minutes before the hysteroscopy will start. The second group will receive two 250 mg tablets Naproxen® 60-30 minutes before the hysteroscopy will start. The third group will receive two 500 mg placebo tablets 60-30 minutes before the hysteroscopy. Primary outcome is pain intensity, measured with a VAS at the insertion of the instrument, during hysteroscopy, at the end and 30 minutes after the procedure. Secondary outcomes are adverse effects and complications during the hysteroscopy, monitored until 30 minutes after the hysteroscopy and evaluated by phone the following day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nifedipine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Other use
    Dosage and administration details
    The investigational product is nifedipine, this is a calcium re-entry blocker, which is widely used in cardiovascular treatment. Nifedipine is a dihydropyridine and inhibits the calcium-influx. Nifedipine capsules are short-acting and are used when a rapid effect is needed.8 For the study, Nifedipine® capsules of 10 mg will be used.

    Arm title
    		 Second
    Arm description
    		 A multicentre single-blinded pilot study with a naproxen and placebo controlled, randomized study design. We will include 60 women at each side, scheduled for a hysteroscopy. One group will receive two 10 mg capsules short-acting Nifedipine® 60-30 minutes before the hysteroscopy will start. The second group will receive two 250 mg tablets Naproxen® 60-30 minutes before the hysteroscopy will start. The third group will receive two 500 mg placebo tablets 60-30 minutes before the hysteroscopy. Primary outcome is pain intensity, measured with a VAS at the insertion of the instrument, during hysteroscopy, at the end and 30 minutes after the procedure. Secondary outcomes are adverse effects and complications during the hysteroscopy, monitored until 30 minutes after the hysteroscopy and evaluated by phone the following day.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Naproxen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Other use
    Dosage and administration details
    Naproxen is used as a comparator, naproxen is a nonsteroidal anti-inflammatory agent, which is used as pain medication. It is common use in the Netherlands to advice patients to take naproxen before a hysteroscopy. For the study, Naproxen® tablets of 250 mg will be used.

    Arm title
    		 Third
    Arm description
    		 A multicentre single-blinded pilot study with a naproxen and placebo controlled, randomized study design. We will include 60 women at each side, scheduled for a hysteroscopy. One group will receive two 10 mg capsules short-acting Nifedipine® 60-30 minutes before the hysteroscopy will start. The second group will receive two 250 mg tablets Naproxen® 60-30 minutes before the hysteroscopy will start. The third group will receive two 500 mg placebo tablets 60-30 minutes before the hysteroscopy. Primary outcome is pain intensity, measured with a VAS at the insertion of the instrument, during hysteroscopy, at the end and 30 minutes after the procedure. Secondary outcomes are adverse effects and complications during the hysteroscopy, monitored until 30 minutes after the hysteroscopy and evaluated by phone the following day.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Other use
    Dosage and administration details
    The placebos will contain 500 mg lactose each

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: See attachments
    Number of subjects in period 1
    		Frist group Second Third
    Started
    21
    19
    20
    Completed
    21
    19
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Period
    Reporting group description
    		 -

    Reporting group values
    		 Period Total
    Number of subjects
    		 60 60
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 60 60
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 60 60
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Frist group
    Reporting group description
    		 A multicentre single-blinded pilot study with a naproxen and placebo controlled, randomized study design. We will include 60 women at each side, scheduled for a hysteroscopy. One group will receive two 10 mg capsules short-acting Nifedipine® 60-30 minutes before the hysteroscopy will start. The second group will receive two 250 mg tablets Naproxen® 60-30 minutes before the hysteroscopy will start. The third group will receive two 500 mg placebo tablets 60-30 minutes before the hysteroscopy. Primary outcome is pain intensity, measured with a VAS at the insertion of the instrument, during hysteroscopy, at the end and 30 minutes after the procedure. Secondary outcomes are adverse effects and complications during the hysteroscopy, monitored until 30 minutes after the hysteroscopy and evaluated by phone the following day.

    Reporting group title
    Second
    Reporting group description
    		 A multicentre single-blinded pilot study with a naproxen and placebo controlled, randomized study design. We will include 60 women at each side, scheduled for a hysteroscopy. One group will receive two 10 mg capsules short-acting Nifedipine® 60-30 minutes before the hysteroscopy will start. The second group will receive two 250 mg tablets Naproxen® 60-30 minutes before the hysteroscopy will start. The third group will receive two 500 mg placebo tablets 60-30 minutes before the hysteroscopy. Primary outcome is pain intensity, measured with a VAS at the insertion of the instrument, during hysteroscopy, at the end and 30 minutes after the procedure. Secondary outcomes are adverse effects and complications during the hysteroscopy, monitored until 30 minutes after the hysteroscopy and evaluated by phone the following day.

    Reporting group title
    Third
    Reporting group description
    		 A multicentre single-blinded pilot study with a naproxen and placebo controlled, randomized study design. We will include 60 women at each side, scheduled for a hysteroscopy. One group will receive two 10 mg capsules short-acting Nifedipine® 60-30 minutes before the hysteroscopy will start. The second group will receive two 250 mg tablets Naproxen® 60-30 minutes before the hysteroscopy will start. The third group will receive two 500 mg placebo tablets 60-30 minutes before the hysteroscopy. Primary outcome is pain intensity, measured with a VAS at the insertion of the instrument, during hysteroscopy, at the end and 30 minutes after the procedure. Secondary outcomes are adverse effects and complications during the hysteroscopy, monitored until 30 minutes after the hysteroscopy and evaluated by phone the following day.

    Primary: Main

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    End point title
    		 Main [1]
    End point description
    The main study parameter will be the intensity of pain. This pain will be measured using a VAS.
    End point type
    Primary
    End point timeframe
    During the study
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: See attachments
    End point values
    		 Frist group Second Third
    Number of subjects analysed
    21
    19
    20
    Units: VAS
        number (not applicable)
    21
    19
    20
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During the study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: See attachments

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Jul 2019
    Inclusion criteria - blood pressure 110/60 mmHg
    28 Nov 2019
    Inclusion criteria - BMI 35
    01 Nov 2022
    We never started to include in the Netherlands because of logistical and administrative reasons. Therefore, this was a moncentric pilot study, including 60 women (in stead of a multicentric study including 120 patients). This could only be registered through entering 59 inclusion in Belgium and 1 inclusion in the Netherlands. The actual inclusion rate was 60 in Belgium and none in the Netherlands.

    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
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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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