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    Clinical Trial Results:
    A phase 2 study investigating the feasibility of using a topical formulation of lidocaine (SHACT) for hysteroscopy in women.

    Summary
    EudraCT number
    		 2013-001775-20
    Trial protocol
    		 SE  
    Global end of trial date
    31 Jan 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jan 2022
    First version publication date
    11 Jan 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PH-HYS-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pharmanest
    Sponsor organisation address
    Retzius väg 8 Solna, Stockholm, Sweden, SE-171 65
    Public contact
    Medical Advisor, Pharamanest, +46 70 6083111, gunvor.ekman-ordeberg@ki.se
    Scientific contact
    Medical Advisor, Pharamanest, +46 70 6083111, gunvor.ekman-ordeberg@ki.se
    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
    11 Mar 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jan 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To obtain initial information regarding the feasibility of using SHACT as a formulation for hysteroscopy .
    Protection of trial subjects
    SHACT is administered when the patient is under general anesthesia, according to the Instruction for Use, supplied with the applicator.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Nov 2013
    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
    Sweden: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    10
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Territory is Sweden. First patient in: 26-Nov-2013 Last patient out: 15-Jan-2014

    Pre-assignment
    Screening details
    		 Inclusion criteria - Planned for hysteroscopy under anesthesia - Minimum 18 years of age - Written informed consent after verbal and written information Exclusion criteria - Contraindication for hysteroscopy with lidocaine application at the discretion of the principal investigator - Known allergy to lidocaine - Recidivating porphyria

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Overall
    Arm description
    		 Women undergoing hysteroscopy
    Arm type
    		 Experimental

    Investigational medicinal product name
    SHACT 4% viscous solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel, Vaginal solution
    Routes of administration
    Intracervical use
    Dosage and administration details
    SHACT 4% viscous solution consists of a topical preparation which provides analgesia by releasing lidocaine from the vehicle into the mucosa and affecting pain receptors and nerve endings

    Number of subjects in period 1
    		Overall
    Started
    10
    Completed
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 10 10
    Age categorical
    The age of the subjects is ≥ 18 yrs
    Units: Subjects
        Adults (18-64 years)
    		 10 10
    Gender categorical
    The subjects were women (≥ 18 yrs) that were planned for hysteroscopy .
    Units: Subjects
        Female
    		 10 10
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 Women undergoing hysteroscopy

    Primary: Feasibility of SHACT

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    End point title
    		 Feasibility of SHACT [1]
    End point description
    End point type
    Primary
    End point timeframe
    Feasibility of SHACT was assessed by the principal investigator by responding to a number of questions for each patient after the hysteroscopy was completed.
    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: The primary end point was to obtain initial information regarding the feasibility of using SHACT as a formulation for hysteroscopy. No statistical analysis was defined in the study protocol.
    End point values
    		 Overall
    Number of subjects analysed
    10
    Units: Patients
    10
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    After the patient has wakened up after the hysteroscopy, she is asked about any unusual negative symptoms or signs. The patient is followed up the day after hysteroscopy as well.
    Adverse event reporting additional description
    According to the protocol, only adverse events which according to the investigator are unusual and not recognized as expected postoperative symptoms after hysteroscopy were to be recorded as AEs.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 All patients received the study drug and are therefore included in the safety analysis set. Some patients did not receive the full volume of 8.5 ml

    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    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: There were no serious adverse events in the study. Neither was there any other adverse events reported. According to the protocol, only adverse events which according to the investigator are unusual and not recognized as expected postoperative symptoms after hysteroscopy were to be recorded as AEs.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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