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    Clinical Trial Results:
    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 vulvo vaginal atrophy (VVA)

    Summary
    EudraCT number
    		 2019-002325-30
    Trial protocol
    		 DE  
    Global end of trial date
    11 Aug 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Nov 2021
    First version publication date
    12 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VMP-03/2018
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04222647
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dr. August Wolff GmbH & Co. KG Arzneimittel
    Sponsor organisation address
    Sudbrackstr. 56, Bielefeld, Germany, 33611
    Public contact
    Clinical Trial Disclosures Office, Dr. August Wolff GmbH & Co. KG Arzneimittel, ClinicalTrialDisclosures@drwolffgroup.com
    Scientific contact
    Clinical Trial Disclosures Office, Dr. August Wolff GmbH & Co. KG Arzneimittel, ClinicalTrialDisclosures@drwolffgroup.com
    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 Oct 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Aug 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Aug 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this trial is to investigate the changes in the Vaginal Maturation Index (VMI) during the course of the trial.
    Protection of trial subjects
    This study was in compliance with the ethical principles of current applicable regulations, International Council for Harmonisation (ICH) of Good Clinical Practice, the principles of the Declaration of Helsinki, as well as other applicable local ethical and legal requirements. All regulatory requirements relevant to the safety of the study participants were followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Jan 2020
    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
    Germany: 43
    Worldwide total number of subjects
    43
    EEA total number of subjects
    43
    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)
    25
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Post-menopausal women with the subjective symptoms of “vulvovaginal atrophy” were contacted and invited to the gynecological examination. If all the inclusion criteria were met, patients underwent the gynecological examination for the assessment of the VMI.

    Pre-assignment
    Screening details
    		 111 women were screened. 49 patients were eligible to participate and of those, 43 patients were enrolled in this study.

    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
    		 Vagisan®
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vagisan®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suppository
    Routes of administration
    Vaginal use
    Dosage and administration details
    During the first week, the suppository was applied intra-vaginally once daily (in the evening); during the following 5 weeks, the suppository was applied twice a week with a time period of at least 72 hours in between two consecutive applications. The total duration of application was 6 weeks. All applications were performed by the patients themselves at home.

    Number of subjects in period 1
    		Vagisan®
    Started
    43
    Completed
    40
    Not completed
    3
         Adverse event, non-fatal
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Vagisan®
    Reporting group description
    		 -

    Reporting group values
    		 Vagisan® Total
    Number of subjects
    		 43 43
    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)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        Women (53-78 years)
    		 43 43
    Gender categorical
    Units: Subjects
        Female
    		 43 43
        Male
    		 0 0
    Subject analysis sets

    Subject analysis set title
    Vagisan® (SP)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety population (SP) for Vagisan®. The Safety Population (SP) includes all patients who were included to the trial according to protocol and who received at least one application of the investigational product, regardless of the number of further assessments.

    Subject analysis set title
    Vagisan® (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set (FAS) for Vagisan®. The Full Analysis Set (FAS) includes all patients of Safety Population for whom at least one post-Baseline assessment was performed (LOCF).

    Subject analysis set title
    Vagisan® (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol population (PP) for Vagisan®. The Per protocol population (PP) includes all patients of FAS who finished the trial in accordance with the CTP without major protocol deviations.

    Subject analysis sets values
    		 Vagisan® (SP) Vagisan® (FAS) Vagisan® (PP)
    Number of subjects
    42
    42
    39
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    0
    0
    0
        From 65-84 years
    0
    0
    0
        85 years and over
    0
    0
    0
        Women (53-78 years)
    42
    42
    39
    Age continuous
    Units:
        
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    42
    42
    39
        Male
    0

    End points

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    End points reporting groups
    Reporting group title
    Vagisan®
    Reporting group description
    		 -

    Subject analysis set title
    Vagisan® (SP)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety population (SP) for Vagisan®. The Safety Population (SP) includes all patients who were included to the trial according to protocol and who received at least one application of the investigational product, regardless of the number of further assessments.

    Subject analysis set title
    Vagisan® (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set (FAS) for Vagisan®. The Full Analysis Set (FAS) includes all patients of Safety Population for whom at least one post-Baseline assessment was performed (LOCF).

    Subject analysis set title
    Vagisan® (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol population (PP) for Vagisan®. The Per protocol population (PP) includes all patients of FAS who finished the trial in accordance with the CTP without major protocol deviations.

    Primary: Change of Vaginal Maturation Index (VMI) from Day 1 to Day 43

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    End point title
    		 Change of Vaginal Maturation Index (VMI) from Day 1 to Day 43 [1]
    End point description
    Full Analysis Set. The VMI quantifies the relative proportion of the vaginal parabasal, intermediate, and superficial cells in the vaginal epithelium. The Vaginal Maturation Index is calculated as follows: Vaginal Maturation Index = 1.0 x % superficial cells + 0.5 x % intermediate cells + 0.0 x % parabasal cells
    End point type
    Primary
    End point timeframe
    Day 1 to Day 43
    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: Since there was no comparison group, mean VMI between Day 1 and Day 43 was compared. A paired t-test (one-sided) with a significance level of p = 0.05 was conducted, showing a statistically significant improvement of the VMI
    End point values
    		 Vagisan®
    Number of subjects analysed
    42
    Units: Index
    arithmetic mean (standard deviation)
        Day 1
    8.3 ( 12.2 )
        Day 43
    34.9 ( 19.5 )
    No statistical analyses for this end point

    Secondary: Change of VMI from Day 1 to Day 8 and from Day 8 to Day 43

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    End point title
    		 Change of VMI from Day 1 to Day 8 and from Day 8 to Day 43
    End point description
    Full Analysis Set. The VMI quantifies the relative proportion of the vaginal parabasal, intermediate, and superficial cells in the vaginal epithelium. The Maturation Index is calculated as follows: Maturation Index = 1.0 x % superficial cells + 0.5 x % intermediate cells + 0.0 x % parabasal cells
    End point type
    Secondary
    End point timeframe
    Day 1, Day 8, Day 43
    End point values
    		 Vagisan®
    Number of subjects analysed
    42
    Units: Score
    arithmetic mean (standard deviation)
        Day 1
    8.3 ( 12.2 )
        Day 8
    29.5 ( 18.0 )
        Day 43
    34.9 ( 19.5 )
    No statistical analyses for this end point

    Secondary: Vaginal Health Index (VHI) parameter: Elasticity

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    End point title
    		 Vaginal Health Index (VHI) parameter: Elasticity
    End point description
    Full Analysis Set. 1 (none) to 5 (excellent)
    End point type
    Secondary
    End point timeframe
    Day 1, Day, 8, Day 43
    End point values
    		 Vagisan®
    Number of subjects analysed
    42
    Units: Score
    arithmetic mean (standard deviation)
        Day 1
    2.4 ( 0.9 )
        Day 8
    3.1 ( 0.7 )
        Day 43
    3.6 ( 0.9 )
    No statistical analyses for this end point

    Secondary: Vaginal Health Index (VHI) parameter: Fluid secretion type and consistency

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    End point title
    		 Vaginal Health Index (VHI) parameter: Fluid secretion type and consistency
    End point description
    Full Analysis Set. 1 (none) to 5 (normal, white flocculent).
    End point type
    Secondary
    End point timeframe
    Day 1, Day 8, Day 43
    End point values
    		 Vagisan®
    Number of subjects analysed
    42
    Units: Score
    arithmetic mean (standard deviation)
        Day 1
    1.4 ( 0.6 )
        Day 8
    2.2 ( 1.0 )
        Day 43
    3.2 ( 1.3 )
    No statistical analyses for this end point

    Secondary: Vaginal Health Index (VHI) parameter: Vaginal pH

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    End point title
    		 Vaginal Health Index (VHI) parameter: Vaginal pH
    End point description
    Full Analysis Set. pH ≥ 6.1 (vaginal pH score 1) to pH 5.6 – 6.0 (vaginal pH score 2).
    End point type
    Secondary
    End point timeframe
    Day 1, Day 8, Day 43
    End point values
    		 Vagisan®
    Number of subjects analysed
    42
    Units: pH Score
    arithmetic mean (standard deviation)
        Day 1
    1.1 ( 0.5 )
        Day 8
    1.6 ( 1.1 )
        Day 43
    2.2 ( 1.6 )
    No statistical analyses for this end point

    Secondary: Vaginal Health Index (VHI) parameter: Condition epithelial mucosa

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    End point title
    		 Vaginal Health Index (VHI) parameter: Condition epithelial mucosa
    End point description
    Full Analysis Set. 1 (Petechiae noted before contact) to 5 (Not friable, normal mucosa).
    End point type
    Secondary
    End point timeframe
    Day 1, Day 8, Day 43
    End point values
    		 Vagisan®
    Number of subjects analysed
    42
    Units: Score
    arithmetic mean (standard deviation)
        Day 1
    2.9 ( 1.1 )
        Day 8
    3.6 ( 1.0 )
        Day 43
    3.7 ( 1.2 )
    No statistical analyses for this end point

    Secondary: Vaginal Health Index (VHI) parameter: Moisture

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    End point title
    		 Vaginal Health Index (VHI) parameter: Moisture
    End point description
    Full Analysis Set. 1 (None, mucosa inflamed) to 5 (Normal).
    End point type
    Secondary
    End point timeframe
    Day 1, Day 8, Day 43
    End point values
    		 Vagisan®
    Number of subjects analysed
    42
    Units: Score
    arithmetic mean (standard deviation)
        Day 1
    2.0 ( 0.7 )
        Day 8
    2.9 ( 0.9 )
        Day 43
    3.7 ( 1.0 )
    No statistical analyses for this end point

    Secondary: Total Sum Score of Vaginal Health Index (VHI)

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    End point title
    		 Total Sum Score of Vaginal Health Index (VHI)
    End point description
    Full Analysis Set. Each of the five criteria - elasticity, fluid secretion, pH, epithelial mucosa and moisture - was graded from 1 (worst) to 5 (best) and then summed up, so that the minimum score is 5 (worst) and the maximum score is 25 (best).
    End point type
    Secondary
    End point timeframe
    Day 1, Day 8, Day 43
    End point values
    		 Vagisan®
    Number of subjects analysed
    42
    Units: Score
    arithmetic mean (standard deviation)
        Day 1
    9.9 ( 2.5 )
        Day 8
    13.5 ( 3.5 )
        Day 43
    16.5 ( 5.0 )
    No statistical analyses for this end point

    Secondary: Subjective Symptoms of vulvovaginal atrophy - Dryness

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    End point title
    		 Subjective Symptoms of vulvovaginal atrophy - Dryness
    End point description
    Full Analysis Set. 0=none to 4=very severe
    End point type
    Secondary
    End point timeframe
    Day 1, Day 8, Day 43
    End point values
    		 Vagisan®
    Number of subjects analysed
    42
    Units: Score
    arithmetic mean (standard deviation)
        Day 1
    2.5 ( 0.7 )
        Day 8
    1.2 ( 0.7 )
        Day 43
    0.8 ( 0.8 )
    No statistical analyses for this end point

    Secondary: Subjective Symptoms of vulvovaginal atrophy - Itching

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    End point title
    		 Subjective Symptoms of vulvovaginal atrophy - Itching
    End point description
    Full Analysis Set. 0=none to 4=very severe
    End point type
    Secondary
    End point timeframe
    Day 1, Day 8, Day 43
    End point values
    		 Vagisan®
    Number of subjects analysed
    42
    Units: Score
    arithmetic mean (standard deviation)
        Day 1
    1.7 ( 0.8 )
        Day 8
    0.7 ( 0.8 )
        Day 43
    0.6 ( 0.7 )
    No statistical analyses for this end point

    Secondary: Subjective Symptoms of vulvovaginal atrophy - Burning

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    End point title
    		 Subjective Symptoms of vulvovaginal atrophy - Burning
    End point description
    Full Analysis Set. 0=none to 4=very severe.
    End point type
    Secondary
    End point timeframe
    Day 1, Day 8, Day 43
    End point values
    		 Vagisan®
    Number of subjects analysed
    42
    Units: Score
    arithmetic mean (standard deviation)
        Day 1
    1.4 ( 0.9 )
        Day 8
    0.7 ( 1.0 )
        Day 43
    0.5 ( 0.8 )
    No statistical analyses for this end point

    Secondary: Subjective Symptoms of vulvovaginal atrophy - Pain unrelated to sexual intercourse

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    End point title
    		 Subjective Symptoms of vulvovaginal atrophy - Pain unrelated to sexual intercourse
    End point description
    Full Analysis Set. 0=none to 4=very severe.
    End point type
    Secondary
    End point timeframe
    Day 1, Day 8, Day 43
    End point values
    		 Vagisan®
    Number of subjects analysed
    42
    Units: Score
    arithmetic mean (standard deviation)
        Day 1
    0.4 ( 0.8 )
        Day 8
    0.3 ( 0.8 )
        Day 43
    0.2 ( 0.8 )
    No statistical analyses for this end point

    Secondary: Subjective Symptoms of vulvovaginal atrophy - Sum Score

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    End point title
    		 Subjective Symptoms of vulvovaginal atrophy - Sum Score
    End point description
    Full Analysis Set. The sum score for subjective symptoms of vulvovaginal atrophy is calculated as the sum of the severity scores of each subjective symptom of VVA, dryness, itching, burning and pain unrelated to sexual intercourse. (sum score ranging from 0 – 16).
    End point type
    Secondary
    End point timeframe
    Day 1, Day 8, Day 43
    End point values
    		 Vagisan®
    Number of subjects analysed
    42
    Units: Score
    arithmetic mean (standard deviation)
        Day 1
    6.0 ( 2.0 )
        Day 8
    2.9 ( 2.7 )
        Day 43
    2.0 ( 2.6 )
    No statistical analyses for this end point

    Secondary: Dyspareunia

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    End point title
    		 Dyspareunia
    End point description
    Only women of the FAS with continuous sexual activity over the course of the study were included in the analysis. 0=none to 4=very severe.
    End point type
    Secondary
    End point timeframe
    Day 1, Day 8 Day 43
    End point values
    		 Vagisan®
    Number of subjects analysed
    5
    Units: Score
    arithmetic mean (standard deviation)
        Day 1
    2.8 ( 1.6 )
        Day 8
    1.0 ( 1.2 )
        Day 43
    0.8 ( 0.8 )
    No statistical analyses for this end point

    Secondary: Number of patients with normal Lactobacillus Flora Status

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    End point title
    		 Number of patients with normal Lactobacillus Flora Status
    End point description
    Full Analysis Set. Normal Lactobacillus flora status: 5 x 10^7 – 1 x 10^9 CFU.
    End point type
    Secondary
    End point timeframe
    Day 1, Day 8, Day 43
    End point values
    		 Vagisan®
    Number of subjects analysed
    42
    Units: Number of patients
        Day 1
    1
        Day 8
    2
        Day 43
    5
    No statistical analyses for this end point

    Secondary: DIVA Domain Score Part A - Daily Activity

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    End point title
    		 DIVA Domain Score Part A - Daily Activity
    End point description
    Full Analysis Set. Evaluation of Impact of Vaginal Aging on Daily Activities (0=not at all to 4=extremely)
    End point type
    Secondary
    End point timeframe
    Day 1, Day 8, Day 43
    End point values
    		 Vagisan®
    Number of subjects analysed
    42 [2]
    Units: Score
    arithmetic mean (standard deviation)
        Day 1
    1.1 ( 0.69 )
        Day 8
    0.87 ( 0.86 )
        Day 43
    0.51 ( 0.67 )
    Notes
    [2] - Day 1: 41 subjects Day 8 and Day 43: 42 subjects
    No statistical analyses for this end point

    Secondary: DIVA Domain Score Part B - Emotional Well-Being

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    End point title
    		 DIVA Domain Score Part B - Emotional Well-Being
    End point description
    Full Analysis Set. Evaluation of Impact of Vaginal Aging on Emotional Well-Being (0=not at all to 4=extremely)
    End point type
    Secondary
    End point timeframe
    Day 1, Day 8, Day 43
    End point values
    		 Vagisan®
    Number of subjects analysed
    42
    Units: Score
    arithmetic mean (standard deviation)
        Day 1
    0.96 ( 0.80 )
        Day 8
    0.68 ( 0.65 )
        Day 43
    0.36 ( 0.47 )
    No statistical analyses for this end point

    Secondary: DIVA Domain Score Part C - Sexual Functioning

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    End point title
    		 DIVA Domain Score Part C - Sexual Functioning
    End point description
    Full Analysis Set. Evaluation of Impact of Vaginal Aging on Sexual Functioning (0=not at all to 4=extremely). In case of varying sexual activity of the patient during the course of the trial the domain subscale Part C, namely questions 12, 13, 14, and 15 are influenced. Therefore, these questions were not included into the calculation of the DIVA domain scores.
    End point type
    Secondary
    End point timeframe
    Day 1, Day 8, Day 43
    End point values
    		 Vagisan®
    Number of subjects analysed
    42 [3]
    Units: Score
    arithmetic mean (standard deviation)
        Day 1
    1.52 ( 1.07 )
        Day 8
    1.31 ( 1.06 )
        Day 43
    0.88 ( 0.81 )
    Notes
    [3] - Day 1: 41 subjects Day 8 and Day 43: 42 subjects
    No statistical analyses for this end point

    Secondary: DIVA Domain Score Part D - Self-Concept and Body Image

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    End point title
    		 DIVA Domain Score Part D - Self-Concept and Body Image
    End point description
    Full Analysis Set. Evaluation of Impact of Vaginal Aging on Self-Concept and Body Image (0=not at all to 4=extremely)
    End point type
    Secondary
    End point timeframe
    Day 1, Day 8, Day 43
    End point values
    		 Vagisan®
    Number of subjects analysed
    42
    Units: Score
    arithmetic mean (standard deviation)
        Day 1
    1.78 ( 1.1 )
        Day 8
    1.19 ( 1.04 )
        Day 43
    0.81 ( 0.71 )
    No statistical analyses for this end point

    Secondary: Total DIVA Score

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    End point title
    		 Total DIVA Score
    End point description
    Full Analysis Set. The DIVA questionnaire addressed the impact of vaginal symptoms such as vaginal dryness, soreness, irritation and itching on the day-today life regarding the patient's activities, relationships, and feelings by any of these symptoms calculated as the sum of the DIVA Domain Scores A,B,C and D (0-16).
    End point type
    Secondary
    End point timeframe
    Day 1, Day 8, Day 43
    End point values
    		 Vagisan®
    Number of subjects analysed
    42 [4]
    Units: Score
    arithmetic mean (standard deviation)
        Day 1
    5.45 ( 2.8 )
        Day 8
    4.05 ( 2.88 )
        Day 43
    2.57 ( 1.97 )
    Notes
    [4] - Day 1: 40 subjects Day 8 and Day 43: 42 subjects
    No statistical analyses for this end point

    Secondary: Global Judgement of Tolerability by the Investigator

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    End point title
    		 Global Judgement of Tolerability by the Investigator
    End point description
    Safety Population. The global judgement of tolerability was assessed by the Investigator on Day 43 according to the following scale: 1=very good to 4=poor.
    End point type
    Secondary
    End point timeframe
    Day 43
    End point values
    		 Vagisan®
    Number of subjects analysed
    40
    Units: Score
    arithmetic mean (standard deviation)
        Day 43
    1.8 ( 0.5 )
    No statistical analyses for this end point

    Secondary: Global Judgement of Tolerability by the Patient

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    End point title
    		 Global Judgement of Tolerability by the Patient
    End point description
    Safety Population. The global judgement of tolerability was assessed by the patient on Day 43 according to the following scale: 1=very good to 4=poor.
    End point type
    Secondary
    End point timeframe
    Day 43
    End point values
    		 Vagisan®
    Number of subjects analysed
    40
    Units: Score
    arithmetic mean (standard deviation)
        Day 43
    1.7 ( 0.7 )
    No statistical analyses for this end point

    Secondary: Safety parameters: number of changes in concomitant medication

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    End point title
    		 Safety parameters: number of changes in concomitant medication
    End point description
    Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Screening - Day 43
    End point values
    		 Vagisan®
    Number of subjects analysed
    42 [5]
    Units: Number of changes
        Screening - Day 43
    25
    Notes
    [5] - changes in concomitant therapies were observed in 10 patients
    No statistical analyses for this end point

    Secondary: Safety parameters: number of patients with clinically relevant change of blood pressure

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    End point title
    		 Safety parameters: number of patients with clinically relevant change of blood pressure
    End point description
    Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Screening -Day 43
    End point values
    		 Vagisan®
    Number of subjects analysed
    42
    Units: Number of patients
        Screening -Day 43
    0
    No statistical analyses for this end point

    Secondary: Safety parameters: number of patients with clinically relevant change of pulse rate

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    End point title
    		 Safety parameters: number of patients with clinically relevant change of pulse rate
    End point description
    Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Screening - Day 43
    End point values
    		 Vagisan®
    Number of subjects analysed
    42
    Units: Number of patients
        Screening - Day 43
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Screening - Day 43
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Vagisan®
    Reporting group description
    		 -

    Serious adverse events
    		 Vagisan®
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 42 (2.38%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Vagisan®
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 42 (59.52%)
    Injury, poisoning and procedural complications
    Vaccination complication
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 42 (11.90%)
         occurrences all number
    8
    Migraine
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    General disorders and administration site conditions
    Application site pain
         subjects affected / exposed
    14 / 42 (33.33%)
         occurrences all number
    17
    Instillation site warmth
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Vaginal discharge
         subjects affected / exposed
    10 / 42 (23.81%)
         occurrences all number
    11
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Psychiatric disorders
    Sleep disorder
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Renal and urinary disorders
    Bladder irritation
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Back pain
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Sjogren's syndrome
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Infections and infestations
    Cystitis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Oct 2019
    The content of L-lactic acid was updated, taking into account the Ph. Eur. specification for content. According to Ph. Eur, the content of anhydrous L-lactic acid is 90% w/w (range between 88.0% - 92.0% (w/w). Therefore, 167 mg L-lactic acid equal to 150 mg anhydrous L-lactic acid. In combination with 50 mg sodium L-lactate solution, which equals to 40 mg anhydrous L-lactic acid, this results in a total of 190 mg of anhydrous L-lactic acid. The primary packaging of the vaginal suppositories was changed from PVC/PVDC/PE blisters to Alu/PE blisters.
    25 Mar 2020
    Temporary halt of the study due to Covid-19 on 25MAR2020
    27 Apr 2020
    Re-start of the study (June 2020)
    04 Jun 2020
    Addition to the Risk Benefit Analysis of the protocol

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    25 Mar 2020
    Temporary halt of the study due to Covid-19
    04 Jun 2020

    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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