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    Clinical Trial Results:
    Prospective, open-label, multicenter, multinational, randomized trial to investigate the non-inferiority of treatment with Vagisan® Moisturising Cream in comparison to an Estriol containing cream in a panel of post-menopausal women suffering from the symptoms of "vulvovaginal dryness" in a parallel group design

    Summary
    EudraCT number
    		 2016-002199-28
    Trial protocol
    		 DE  
    Global end of trial date
    19 Jun 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Dec 2021
    First version publication date
    13 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VFCr-12/2015
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03044652
    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 Disclosure Office, Dr. August Wolff GmbH & Co. KG Arzneimittel, AW-ClinicalTrialDisclosures@drwolffgroup.com
    Scientific contact
    Clinical Trial Disclosure Office, Dr. August Wolff GmbH & Co. KG Arzneimittel, AW-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
    18 Jan 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Jun 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jun 2017
    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 non-inferiority of the treatment of "vulvovaginal dryness" with Vagisan® Moisturising Cream in comparison to an Estriol containing cream. The comparison will be based on the subjective assessment of the symptoms of "vulvovaginal dryness" (Total Severity Score: sum score of the single subjective symptom parameters dryness, itching, burning and pain unrelated to sexual intercourse).
    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
    07 Nov 2016
    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: 162
    Country: Number of subjects enrolled
    Switzerland: 10
    Worldwide total number of subjects
    172
    EEA total number of subjects
    162
    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)
    130
    From 65 to 84 years
    42
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 199 women were screened. 24 women failed to comply with the in- and exclusion criteria while 3 women withdrew from the trial. Hence, 172 of 199 women (86.4 %) had been eligible to be randomized to one of the two treatment arms.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Vagisan® Moisturising Cream
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vagisan® Moisturising Cream
    Investigational medicinal product code
    Other name
    Vagisan® FeuchtCreme
    Pharmaceutical forms
    Cream
    Routes of administration
    Vaginal use
    Dosage and administration details
    2.5 g of the investigational product Vagisan® Moisturising Cream was applied intravaginally, once daily in the evening. After improvement of the symptoms the frequency could be reduced by the patient as needed. In addition, a 0.5 cm strand of cream (1 fingertip unit) could be applied to the outer genital area as needed (also several times per day). All applications were performed by the patients themselves at home for 6 weeks.

    Arm title
    		 Ovestin® 1 mg Creme
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ovestin® 1 mg Creme
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Vaginal use
    Dosage and administration details
    0.5 g of the reference product Ovestin® was applied intravaginally once daily in the evening for the first 3 weeks. Subsequently, the frequency was reduced to twice a week for the last 3 weeks for all patients in this treatment group. All applications were performed by the patients themselves at home for 6 weeks.

    Number of subjects in period 1
    		Vagisan® Moisturising Cream Ovestin® 1 mg Creme
    Started
    87
    85
    Completed
    84
    78
    Not completed
    3
    7
         Consent withdrawn by subject
    1
    2
         Adverse event, non-fatal
    -
    4
         The husband did not like her vaginal changes
    1
    -
         Protocol deviation
    1
    1

    Baseline characteristics

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

    Reporting group title
    Ovestin® 1 mg Creme
    Reporting group description
    		 -

    Reporting group values
    		 Vagisan® Moisturising Cream Ovestin® 1 mg Creme Total
    Number of subjects
    		 87 85 172
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.4 ± 7.3 61.7 ± 7.1 -
    Gender categorical
    Units: Subjects
        Female
    		 87 85 172

    End points

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

    Reporting group title
    Ovestin® 1 mg Creme
    Reporting group description
    		 -

    Subject analysis set title
    Vagisan (SP)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety population (SP) for Vagisan® Moisturising Cream. The safety population (SP) includes all patients who were included to the trial and who received at least one application of the test products, regardless of the number of further assessments.

    Subject analysis set title
    Ovestin (SP)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety population (SP) for Ovestin® 1 mg Creme. The safety population (SP) includes all patients who were included to the trial and who received at least one application of the test products, regardless of the number of further assessments.

    Subject analysis set title
    Vagisan (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to treat population (ITT) for Vagisan® Moisturising Cream. The intention to treat population (ITT) includes all patients of the safety population (SP) with at least one post-baseline assessment.

    Subject analysis set title
    Ovestin (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to treat population (ITT) for Ovestin® 1 mg Creme. The intention to treat population (ITT) includes all patients of the safety population (SP) with at least one post-baseline assessment.

    Subject analysis set title
    Vagisan (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol population (PP) for Vagisan® Moisturising Cream. The per protocol population (PP) includes all patients of the intention to treat population (ITT) who finished the trial in accordance with the trial protocol without major protocol deviations.

    Subject analysis set title
    Ovestin (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol population (PP) for Ovestin® 1 mg Creme. The per protocol population (PP) includes all patients of the intention to treat population (ITT) who finished the trial in accordance with the trial protocol without major protocol deviations.

    Subject analysis set title
    Vagisan subgroup (PP): mild overall impairment daily life
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol population for Vagisan® Moisturising Cream subgroup with mild overall impairment of daily life due to the condition "vaginal dryness" on Study Day 1

    Subject analysis set title
    Vagisan subgroup (PP): moderate overall impairment daily life
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol population for Vagisan® Moisturising Cream subgroup with moderate overall impairment of daily life due to the condition "vaginal dryness" on Study Day 1

    Subject analysis set title
    Vagisan subgroup (PP): severe overall impairment daily life
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol population for Vagisan® Moisturising Cream subgroup with severe overall impairment of daily life due to the condition "vaginal dryness" on Study Day 1

    Subject analysis set title
    Ovestin subgroup (PP): mild overall impairment daily life
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol population for Ovestin® 1 mg Creme subgroup with mild overall impairment of daily life due to the condition "vaginal dryness" on Study Day 1

    Subject analysis set title
    Ovestin subgroup (PP): moderate overall impairment daily life
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol population for Ovestin® 1 mg Creme subgroup with moderate overall impairment of daily life due to the condition "vaginal dryness" on Study Day 1

    Subject analysis set title
    Ovestin subgroup (PP): severe overall impairment daily life
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol population for Ovestin® 1 mg Creme subgroup with severe overall impairment of daily life due to the condition "vaginal dryness" on Study Day 1

    Subject analysis set title
    Vagisan (PP) Day 1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol (PP) population for Vagisan® Moisturising Cream on Day 1.

    Subject analysis set title
    Vagisan (PP) Day 43
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol (PP) population for Vagisan® Moisturising Cream on Day 43.

    Subject analysis set title
    Ovestin (PP) Day 1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol (PP) population for Ovestin® 1 mg Creme on Day 1.

    Subject analysis set title
    Ovestin (PP) Day 43
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol (PP) population for Ovestin® 1 mg Creme on Day 43.

    Subject analysis set title
    Vagisan (PP) Day 22
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol (PP) population for Vagisan® Moisturising Cream on Day 22.

    Subject analysis set title
    Ovestin (PP) Day 22
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol (PP) population for Ovestin® 1 mg Creme on Day 22.

    Primary: Non inferiority, assessed by the difference of the Total Severity Score between baseline and after six weeks of treatment

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    End point title
    		 Non inferiority, assessed by the difference of the Total Severity Score between baseline and after six weeks of treatment
    End point description
    Main analysis based on per protocol population (PP). In accordance with the recommendations of the FDA for non-inferiority trials (2010), a second analysis was performed on the ITT population. The Total Severity Score is defined as the sum of the single parameters dryness, itching, burning and pain unrelated to sexual intercourse, each scored from 0 = none to 4 = very severe. In total a range of 0 = no complaints to 16 = very severe complaints is possible.
    End point type
    Primary
    End point timeframe
    Visit 1 (Day 1) to Visit 3 (Day 43)
    End point values
    		 Vagisan (ITT) Ovestin (ITT) Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    85
    81
    80
    71
    Units: Difference of the Total Severity Score
        arithmetic mean (standard deviation)
    -5.0 ± 2.2
    -5.3 ± 2.4
    -5.0 ± 2.2
    -5.4 ± 2.1
    Statistical analysis title
    		 Test of non-inferiority (PP)
    Statistical analysis description
    Mann-Whitney-Wilcoxon Test was utilized to evaluate non-inferiority of the treatment Vagisan® in comparison to Ovestin® based on the differences of the Total Severity Score between Baseline and Day 43
    Comparison groups
    Vagisan (PP) v Ovestin (PP)
    Number of subjects included in analysis
    151
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 = 0.0002
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - Non-inferiority margin of 1.5 units
    Statistical analysis title
    		 Test of non-inferiority (ITT)
    Statistical analysis description
    One-sided Independent t-Test was utilized to evaluate non-inferiority of the treatment Vagisan® in comparison to Ovestin® based on the differences of the Total Severity Score between Baseline and Day 43
    Comparison groups
    Ovestin (ITT) v Vagisan (ITT)
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    P-value
    		 = 0.0006
    Method
    		 t-test, 1-sided
    Confidence interval
    Notes
    [2] - Non-inferiority margin of 1.5 units

    Secondary: Severity scoring for dryness

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    End point title
    		 Severity scoring for dryness
    End point description
    Severity scored from 0 = none to 4 = very severe.
    End point type
    Secondary
    End point timeframe
    At each visit and once weekly (Days 1, 7, 14, 21, 22, 28, 35, 42, 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    80 [3]
    71 [4]
    Units: Severity scoring
    arithmetic mean (standard deviation)
        Day 1
    2.3 ± 0.8
    2.3 ± 0.9
        Day 7
    1.1 ± 0.9
    1.0 ± 0.8
        Day 14
    0.8 ± 0.9
    0.6 ± 0.7
        Day 21
    0.7 ± 0.7
    0.4 ± 0.6
        Day 22
    0.7 ± 0.7
    0.5 ± 0.7
        Day 28
    0.5 ± 0.6
    0.3 ± 0.5
        Day 35
    0.5 ± 0.6
    0.3 ± 0.5
        Day 42
    0.4 ± 0.6
    0.2 ± 0.4
        Day 43
    0.4 ± 0.6
    0.2 ± 0.4
    Notes
    [3] - n = 80 (D1); 78 (D7); 78 (D14); 79 (D21); 80 (D22); 76 (D28); 77 (D35); 75 (D42); 80 (D43)
    [4] - n = 71 (D1); 71 (D7); 67 (D14); 70 (D21); 70 (D22); 70 (D28); 71 (D35); 70 (D42); 71 (D43)
    No statistical analyses for this end point

    Secondary: Severity scoring for itching

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    End point title
    		 Severity scoring for itching
    End point description
    Severity scored from 0 = none to 4 = very severe.
    End point type
    Secondary
    End point timeframe
    At each visit and once weekly (Days 1, 7, 14, 21, 22, 28, 35, 42, 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    80 [5]
    71 [6]
    Units: Severity scoring
    arithmetic mean (standard deviation)
        Day 1
    1.4 ± 1.0
    1.4 ± 0.9
        Day 7
    0.8 ± 0.8
    0.8 ± 0.8
        Day 14
    0.7 ± 0.8
    0.7 ± 0.8
        Day 21
    0.5 ± 0.6
    0.4 ± 0.7
        Day 22
    0.5 ± 0.7
    0.5 ± 0.7
        Day 28
    0.4 ± 0.5
    0.4 ± 0.5
        Day 35
    0.3 ± 0.6
    0.3 ± 0.6
        Day 42
    0.2 ± 0.5
    0.2 ± 0.4
        Day 43
    0.3 ± 0.5
    0.2 ± 0.4
    Notes
    [5] - n = 80 (D1); 78 (D7); 78 (D14); 78 (D21); 80 (D22); 75 (D28); 77 (D35); 75 (D42); 80 (D43)
    [6] - n = 71 (D1); 70 (D7); 67 (D14); 69 (D21); 71 (D22); 71 (D28); 71 (D35); 70 (D42); 71 (D43)
    No statistical analyses for this end point

    Secondary: Severity scoring for burning

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    End point title
    		 Severity scoring for burning
    End point description
    Severity scored from 0 = none to 4 = very severe.
    End point type
    Secondary
    End point timeframe
    At each visit and once weekly (Days 1, 7, 14, 21, 22, 28, 35, 42, 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    80 [7]
    71 [8]
    Units: Severity scoring
    arithmetic mean (standard deviation)
        Day 1
    1.4 ± 1.0
    1.5 ± 1.0
        Day 7
    0.7 ± 0.8
    0.6 ± 0.8
        Day 14
    0.6 ± 0.7
    0.5 ± 0.7
        Day 21
    0.4 ± 0.6
    0.4 ± 0.6
        Day 22
    0.6 ± 0.7
    0.4 ± 0.6
        Day 28
    0.4 ± 0.6
    0.3 ± 0.5
        Day 35
    0.3 ± 0.6
    0.2 ± 0.5
        Day 42
    0.3 ± 0.5
    0.1 ± 0.3
        Day 43
    0.3 ± 0.6
    0.1 ± 0.3
    Notes
    [7] - n = 80 (D1); 78 (D7); 78 (D14); 79 (D21); 80 (D22); 76 (D28); 77 (D35); 75 (D42); 80 (D43)
    [8] - n = 71 (D1); 70 (D7); 67 (D14); 70 (D21); 71 (D22); 71 (D28); 71 (D35); 69 (D42); 71 (D43)
    No statistical analyses for this end point

    Secondary: Severity scoring for pain unrelated to sexual intercourse

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    End point title
    		 Severity scoring for pain unrelated to sexual intercourse
    End point description
    Severity scored from 0 = none to 4 = very severe.
    End point type
    Secondary
    End point timeframe
    At each visit and once weekly (Days 1, 7, 14, 21, 22, 28, 35, 42, 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    80 [9]
    71 [10]
    Units: Severity scoring
    arithmetic mean (standard deviation)
        Day 1
    1.1 ± 0.9
    0.8 ± 1.0
        Day 7
    0.5 ± 0.8
    0.4 ± 0.7
        Day 14
    0.4 ± 0.7
    0.2 ± 0.6
        Day 21
    0.3 ± 0.5
    0.2 ± 0.5
        Day 22
    0.4 ± 0.6
    0.2 ± 0.5
        Day 28
    0.3 ± 0.5
    0.1 ± 0.4
        Day 35
    0.2 ± 0.0
    0.1 ± 0.3
        Day 42
    0.1 ± 0.0
    0.0 ± 0.2
        Day 43
    0.2 ± 0.0
    0.1 ± 0.2
    Notes
    [9] - n = 80 (D1); 77 (D7); 78 (D14); 78 (D21); 80 (D22); 76 (D28); 76 (D35); 75 (D42); 80 (D43)
    [10] - n = 71 (D1); 69 (D7); 67 (D14); 70 (D21); 71 (D22); 70 (D28); 71 (D35); 69 (D42); 71 (D43)
    No statistical analyses for this end point

    Secondary: AUC for severity scoring for dryness

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    End point title
    		 AUC for severity scoring for dryness
    End point description
    End point type
    Secondary
    End point timeframe
    Over all assessment time points: At each visit and once weekly (Days 1, 7, 14, 21, 22, 28, 35, 42, 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    72
    64
    Units: Severity score * days
        arithmetic mean (standard deviation)
    34.6 ± 24.9
    27.5 ± 18.8
    No statistical analyses for this end point

    Secondary: AUC for severity scoring for itching

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    End point title
    		 AUC for severity scoring for itching
    End point description
    End point type
    Secondary
    End point timeframe
    Over all assessment time points: At each visit and once weekly (Days 1, 7, 14, 21, 22, 28, 35, 42, 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    70
    65
    Units: Severity score * days
        arithmetic mean (standard deviation)
    25.1 ± 22.6
    21.9 ± 20.2
    No statistical analyses for this end point

    Secondary: AUC for severity scoring for burning

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    End point title
    		 AUC for severity scoring for burning
    End point description
    End point type
    Secondary
    End point timeframe
    Over all assessment time points: At each visit and once weekly (Days 1, 7, 14, 21, 22, 28, 35, 42, 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    71
    65
    Units: Severity score * days
        arithmetic mean (standard deviation)
    23.2 ± 22.8
    18.3 ± 17.1
    No statistical analyses for this end point

    Secondary: AUC for severity scoring for pain unrelated to sexual intercourse

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    End point title
    		 AUC for severity scoring for pain unrelated to sexual intercourse
    End point description
    End point type
    Secondary
    End point timeframe
    Over all assessment time points: At each visit and once weekly (Days 1, 7, 14, 21, 22, 28, 35, 42, 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    71
    65
    Units: Severity score * days
        arithmetic mean (standard deviation)
    15.6 ± 19.4
    9.5 ± 14.5
    No statistical analyses for this end point

    Secondary: Impairment of daily life due to dryness

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    End point title
    		 Impairment of daily life due to dryness
    End point description
    Evaluation on a visual analogue scale (VAS): 0 = no impairment; 10 = very pronounced impairment
    End point type
    Secondary
    End point timeframe
    At each visit and once weekly (Days 1, 7, 14, 21, 22, 28, 35, 42, 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    80 [11]
    71 [12]
    Units: cm
    arithmetic mean (standard deviation)
        Day 1
    5.62 ± 2.34
    5.22 ± 2.81
        Day 7
    2.30 ± 2.52
    1.90 ± 1.98
        Day 14
    1.60 ± 2.13
    1.02 ± 1.60
        Day 21
    1.05 ± 1.60
    0.67 ± 1.36
        Day 22
    1.17 ± 1.53
    0.75 ± 1.37
        Day 28
    0.76 ± 1.28
    0.36 ± 0.89
        Day 35
    0.59 ± 1.15
    0.34 ± 0.88
        Day 42
    0.47 ± 1.08
    0.20 ± 0.59
        Day 43
    0.54 ± 1.17
    0.21 ± 0.56
    Notes
    [11] - n = 80 (D1); 80 (D7); 80 (D14); 79 (D21); 79 (D22); 77 (D28); 78 (D35); 75 (D42); 80 (D43)
    [12] - n = 71 (D1); 71 (D7); 69 (D14); 71 (D21); 71 (D22); 71 (D28); 71 (D35); 70 (D42); 71 (D43)
    No statistical analyses for this end point

    Secondary: Impairment of daily life due to itching

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    End point title
    		 Impairment of daily life due to itching
    End point description
    Evaluation on a visual analogue scale (VAS): 0 = no impairment; 10 = very pronounced impairment
    End point type
    Secondary
    End point timeframe
    At each visit and once weekly (Days 1, 7, 14, 21, 22, 28, 35, 42, 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    80 [13]
    71 [14]
    Units: cm
    arithmetic mean (standard deviation)
        Day 1
    3.90 ± 2.89
    3.79 ± 2.73
        Day 7
    1.66 ± 1.90
    1.48 ± 1.77
        Day 14
    1.16 ± 1.85
    1.03 ± 1.56
        Day 21
    0.65 ± 1.26
    0.68 ± 1.50
        Day 22
    0.72 ± 1.33
    0.80 ± 1.61
        Day 28
    0.46 ± 0.92
    0.36 ± 0.86
        Day 35
    0.34 ± 1.05
    0.36 ± 1.25
        Day 42
    0.30 ± 1.07
    0.15 ± 0.52
        Day 43
    0.34 ± 1.07
    0.20 ± 0.60
    Notes
    [13] - n = 80 (D1); 80 (D7); 80 (D14); 79 (D21); 79 (D22); 76 (D28); 77 (D35); 76 (D42); 80 (D43)
    [14] - n = 71 (D1); 70 (D7); 69 (D14); 71 (D21); 71 (D22); 70 (D28); 70 (D35); 69 (D42); 71 (D43)
    No statistical analyses for this end point

    Secondary: Impairment of daily life due to burning

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    End point title
    		 Impairment of daily life due to burning
    End point description
    Evaluation on a visual analogue scale (VAS): 0 = no impairment; 10 = very pronounced impairment
    End point type
    Secondary
    End point timeframe
    At each visit and once weekly (Days 1, 7, 14, 21, 22, 28, 35, 42, 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    80 [15]
    71 [16]
    Units: cm
    arithmetic mean (standard deviation)
        Day 1
    3.73 ± 3.01
    3.66 ± 3.08
        Day 7
    1.43 ± 1.96
    1.14 ± 1.72
        Day 14
    1.09 ± 1.66
    0.64 ± 1.36
        Day 21
    0.66 ± 1.18
    0.49 ± 1.94
        Day 22
    0.86 ± 1.39
    0.52 ± 1.08
        Day 28
    0.61 ± 1.22
    0.26 ± 0.77
        Day 35
    0.47 ± 1.20
    0.24 ± 0.86
        Day 42
    0.42 ± 1.17
    0.12 ± 0.49
        Day 43
    0.41 ± 1.23
    0.23 ± 1.24
    Notes
    [15] - n = 79 (D1); 80 (D7); 80 (D14); 79 (D21); 80 (D22); 77 (D28); 78 (D35); 76 (D42); 79 (D43)
    [16] - n = 70 (D1); 70 (D7); 69 (D14); 71 (D21); 71 (D22); 70 (D28); 70 (D35); 70 (D42); 71 (D43)
    No statistical analyses for this end point

    Secondary: Impairment of daily life due to pain unrelated to sexual intercourse

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    End point title
    		 Impairment of daily life due to pain unrelated to sexual intercourse
    End point description
    Evaluation on a visual analogue scale (VAS): 0 = no impairment; 10 = very pronounced impairment
    End point type
    Secondary
    End point timeframe
    At each visit and once weekly (Days 1, 7, 14, 21, 22, 28, 35, 42, 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    80 [17]
    71 [18]
    Units: cm
    arithmetic mean (standard deviation)
        Day 1
    2.50 ± 2.62
    1.83 ± 2.66
        Day 7
    1.00 ± 1.85
    0.77 ± 1.68
        Day 14
    0.81 ± 1.58
    0.42 ± 1.14
        Day 21
    0.47 ± 1.02
    0.36 ± 1.00
        Day 28
    0.35 ± 0.91
    0.21 ± 0.80
        Day 35
    0.23 ± 0.73
    0.09 ± 0.40
        Day 42
    0.18 ± 0.72
    0.05 ± 0.37
        Day 43
    0.18 ± 0.69
    0.05 ± 0.28
    Notes
    [17] - n = 79 (D1); 79 (D7); 79 (D14); 78 (D21); 80 (D22); 77 (D28); 78 (D35); 76 (D42); 80 (D43)
    [18] - n = 70 (D1); 69 (D7); 68 (D14); 71 (D21); 70 (D22); 71 (D28); 71 (D35); 70 (D42); 71 (D43)
    No statistical analyses for this end point

    Secondary: AUC for impairment of daily life due to dryness

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    End point title
    		 AUC for impairment of daily life due to dryness
    End point description
    End point type
    Secondary
    End point timeframe
    Over all assessment time points: At each visit and once weekly (Days 1, 7, 14, 21, 22, 28, 35, 42, 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    73
    68
    Units: cm * days
        arithmetic mean (standard deviation)
    61.94 ± 59.35
    46.77 ± 40.94
    No statistical analyses for this end point

    Secondary: AUC for impairment of daily life due to itching

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    End point title
    		 AUC for impairment of daily life due to itching
    End point description
    End point type
    Secondary
    End point timeframe
    Over all assessment time points: At each visit and once weekly (Days 1, 7, 14, 21, 22, 28, 35, 42, 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    73
    66
    Units: cm * days
        arithmetic mean (standard deviation)
    43.87 ± 47.97
    40.12 ± 42.13
    No statistical analyses for this end point

    Secondary: AUC for impairment of daily life due to burning

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    End point title
    		 AUC for impairment of daily life due to burning
    End point description
    End point type
    Secondary
    End point timeframe
    Over all assessment time points: At each visit and once weekly (Days 1, 7, 14, 21, 22, 28, 35, 42, 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    73
    66
    Units: cm * days
        arithmetic mean (standard deviation)
    43.87 ± 50.53
    31.13 ± 36.30
    No statistical analyses for this end point

    Secondary: AUC for impairment of daily life due to pain unrelated to sexual intercourse

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    End point title
    		 AUC for impairment of daily life due to pain unrelated to sexual intercourse
    End point description
    End point type
    Secondary
    End point timeframe
    Over all assessment time points: At each visit and once weekly (Days 1, 7, 14, 21, 22, 28, 35, 42, 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    72
    65
    Units: cm * days
        arithmetic mean (standard deviation)
    26.90 ± 41.06
    18.52 ± 32.44
    No statistical analyses for this end point

    Secondary: Weighted Impairment of Daily Life

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    End point title
    		 Weighted Impairment of Daily Life
    End point description
    Represents the impairment of daily life due to each subjective symptom (dryness, itching, burning and pain unrelated to sexual intercourse) weighted by the severity of the subjective symptoms. Weighted Impairment of Daily Life = ( Severity Scoring (Dryness) * Impairment of Daily Life (Dryness) + Severity Scoring (Itching) * Impairment of Daily Life (Itching) + Severity Scoring (Burning) * Impairment of Daily Life (Burning) + Severity Scoring (Pain) * Impairment of Daily Life (Pain) ) / 16 Range: 1-10
    End point type
    Secondary
    End point timeframe
    At each visit and once weekly (Days 1, 7, 14, 21, 22, 28, 35, 42, 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    79 [19]
    71 [20]
    Units: Score
    arithmetic mean (standard deviation)
        Day 1
    2.11 ± 1.44
    2.02 ± 1.59
        Day 7
    0.66 ± 0.89
    0.56 ± 0.68
        Day 14
    0.47 ± 0.78
    0.32 ± 0.59
        Day 21
    0.25 ± 0.44
    0.21 ± 0.43
        Day 22
    0.31 ± 0.51
    0.22 ± 0.42
        Day 28
    0.19 ± 0.36
    0.09 ± 0.21
        Day 35
    0.16 ± 0.43
    0.11 ± 0.41
        Day 42
    0.14 ± 0.43
    0.03 ± 0.11
        Day 43
    0.14 ± 0.44
    0.05 ± 0.18
    Notes
    [19] - n = 79 (D1); 77 (D7); 76 (D14); 78 (D21); 79 (D22); 74 (D28); 76 (D35); 74 (D42); 79 (D43)
    [20] - n = 70 (D1); 69 (D7); 67 (D14); 69 (D21); 69 (D22); 70 (D28); 69 (D35); 69 (D42); 71 (D43)
    No statistical analyses for this end point

    Secondary: AUC for Weighted Total Severity Score

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    End point title
    		 AUC for Weighted Total Severity Score
    End point description
    End point type
    Secondary
    End point timeframe
    Over all assessment time points: At each visit and once weekly (Days 1, 7, 14, 21, 22, 28, 35, 42, 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    68
    60
    Units: Severity Score * cm * days
        arithmetic mean (standard deviation)
    19.8 ± 21.09
    14.48 ± 14.16
    No statistical analyses for this end point

    Secondary: Severity scoring for dyspareunia (if sexually active)

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    End point title
    		 Severity scoring for dyspareunia (if sexually active)
    End point description
    Severity scored from 0 = none to 4 = very severe
    End point type
    Secondary
    End point timeframe
    Visit 1 (Day 1) and visit 3 (Day 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    64 [21]
    42 [22]
    Units: Severity Score
    arithmetic mean (standard deviation)
        Day 1
    2.6 ± 1.2
    2.7 ± 1.2
        Day 43
    0.9 ± 1.0
    0.5 ± 0.7
    Notes
    [21] - n = 64 (D1); 56 (D43);
    [22] - n = 42 (D1); 38 (D43);
    No statistical analyses for this end point

    Secondary: AUC for severity scoring for dyspareunia (if sexually active)

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    End point title
    		 AUC for severity scoring for dyspareunia (if sexually active)
    End point description
    End point type
    Secondary
    End point timeframe
    Over all assessment time points: At each visit (Days 1, 22, 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    56
    37
    Units: Severity Score * Days
        arithmetic mean (standard deviation)
    73.1 ± 36.3
    67.0 ± 30.8
    No statistical analyses for this end point

    Secondary: Impairment of daily life due to dyspareunia (if sexually active)

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    End point title
    		 Impairment of daily life due to dyspareunia (if sexually active)
    End point description
    Evaluation on a visual analogue scale (VAS): 0 = no impairment; 10 = very pronounced impairment
    End point type
    Secondary
    End point timeframe
    At each visit: Visit 1 (Day 1), visit 2 (Day 22), visit 3 (Day 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    64 [23]
    42 [24]
    Units: cm
    arithmetic mean (standard deviation)
        Day 1
    7.03 ± 2.73
    6.66 ± 2.94
        Day 22
    2.64 ± 2.69
    1.43 ± 2.18
        Day 43
    1.56 ± 2.42
    0.65 ± 1.63
    Notes
    [23] - n = 64 (D1); 57 (D22); 57 (D43);
    [24] - n = 42 (D1); 37 (D22); 37 (D43);
    No statistical analyses for this end point

    Secondary: AUC for impairment of daily life due to dyspareunia (if sexually active)

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    End point title
    		 AUC for impairment of daily life due to dyspareunia (if sexually active)
    End point description
    End point type
    Secondary
    End point timeframe
    Over all assessment time points: At each visit (Days 1, 22, 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    52
    34
    Units: cm * days
        arithmetic mean (standard deviation)
    139.91 ± 87.04
    107.47 ± 73.38
    No statistical analyses for this end point

    Secondary: Overall impairment of daily life due to the condition “vaginal dryness”

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    End point title
    		 Overall impairment of daily life due to the condition “vaginal dryness”
    End point description
    Overall impairment of daily life due to the condition “vaginal dryness”, including a subgroup analysis of patients with mild, moderate and severe overall impairment at each visit. Evaluation on a visual analogue scale (VAS): 0 = no impairment; 10 = very pronounced impairment
    End point type
    Secondary
    End point timeframe
    At each visit: Visit 1 (Days 1), visit 2 (Day 22), visit 3 (Day 43)
    End point values
    		 Vagisan (PP) Ovestin (PP) Vagisan subgroup (PP): mild overall impairment daily life Vagisan subgroup (PP): moderate overall impairment daily life Vagisan subgroup (PP): severe overall impairment daily life Ovestin subgroup (PP): mild overall impairment daily life Ovestin subgroup (PP): moderate overall impairment daily life Ovestin subgroup (PP): severe overall impairment daily life
    Number of subjects analysed
    80 [25]
    71 [26]
    21 [27]
    27 [28]
    32 [29]
    19 [30]
    31 [31]
    21 [32]
    Units: cm
    arithmetic mean (standard deviation)
        Day 1
    5.54 ± 2.63
    4.82 ± 2.56
    2.13 ± 0.95
    4.98 ± 0.86
    8.26 ± 0.83
    1.71 ± 0.93
    4.57 ± 0.94
    8.00 ± 0.94
        Day 22
    1.61 ± 0.23
    1.02 ± 1.64
    0.57 ± 0.84
    1.16 ± 1.64
    2.63 ± 2.42
    0.82 ± 1.30
    1.02 ± 1.71
    1.19 ± 1.86
        Day 43
    0.92 ± 1.76
    0.40 ± 0.99
    0.83 ± 1.78
    0.96 ± 1.76
    0.94 ± 1.79
    0.28 ± 0.86
    0.39 ± 0.72
    0.52 ± 1.39
    Notes
    [25] - n = 80 (D1); 78 (D22); 78 (D43)
    [26] - n = 71 (D1); 70 (D22); 71 (D43)
    [27] - n = 21 (D1); 21 (D22); 20 (D43)
    [28] - n = 27 (D1); 25 (D22); 26 (D43)
    [29] - n = 32 (D1); 32 (D22); 32 (D43)
    [30] - n = 19 (D1); 19 (D22); 19 (D43)
    [31] - n = 31 (D1); 30 (D22); 31 (D43)
    [32] - n = 21 (D1); 21 (D22); 21 (D43)
    No statistical analyses for this end point

    Secondary: AUC for overall impairment of daily life

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    End point title
    		 AUC for overall impairment of daily life
    End point description
    End point type
    Secondary
    End point timeframe
    Over all assessment time points: At each visit (Days 1, 22, 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    76
    70
    Units: cm * Days
        arithmetic mean (standard deviation)
    102.79 ± 67.21
    75.93 ± 50.56
    No statistical analyses for this end point

    Secondary: Vaginal health index parameter elasticity

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    End point title
    		 Vaginal health index parameter elasticity
    End point description
    End point type
    Secondary
    End point timeframe
    At each visit: Visit 1 (Days 1), visit 2 (Day 22), visit 3 (Day 43)
    End point values
    		 Vagisan (PP) Day 1 Vagisan (PP) Day 43 Ovestin (PP) Day 1 Ovestin (PP) Day 43 Vagisan (PP) Day 22 Ovestin (PP) Day 22
    Number of subjects analysed
    80
    80
    71
    71
    80
    71
    Units: Number of patients
        None
    1
    0
    2
    0
    0
    0
        Poor
    33
    3
    26
    1
    3
    1
        Fair
    25
    14
    30
    1
    15
    6
        Good
    19
    50
    12
    26
    51
    30
        Excellent
    2
    11
    1
    42
    7
    33
        Missing
    0
    2
    0
    1
    4
    1
    No statistical analyses for this end point

    Secondary: Vaginal health index parameter fluid secretion

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    End point title
    		 Vaginal health index parameter fluid secretion
    End point description
    End point type
    Secondary
    End point timeframe
    At each visit: Visit 1 (Days 1), visit 2 (Day 22), visit 3 (Day 43)
    End point values
    		 Vagisan (PP) Day 1 Vagisan (PP) Day 43 Ovestin (PP) Day 1 Ovestin (PP) Day 43 Vagisan (PP) Day 22 Ovestin (PP) Day 22
    Number of subjects analysed
    80
    80
    71
    71
    80
    71
    Units: Number of patients
        None
    8
    0
    11
    1
    0
    0
        Scant, thin yellow
    27
    1
    20
    0
    4
    1
        Superficial, thin white
    29
    20
    23
    4
    14
    4
        Moderate, thin white
    10
    43
    15
    22
    44
    22
        Normal (white flocculent)
    6
    14
    2
    43
    14
    43
        Missing
    0
    2
    0
    1
    4
    1
    No statistical analyses for this end point

    Secondary: Vaginal health index parameter pH

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    End point title
    		 Vaginal health index parameter pH
    End point description
    End point type
    Secondary
    End point timeframe
    At each visit: Visit 1 (Days 1), visit 2 (Day 22), visit 3 (Day 43)
    End point values
    		 Vagisan (PP) Day 1 Vagisan (PP) Day 43 Ovestin (PP) Day 1 Ovestin (PP) Day 43 Vagisan (PP) Day 22 Ovestin (PP) Day 22
    Number of subjects analysed
    80
    80
    71
    71
    80
    71
    Units: Number of patients
        >=6.1
    29
    18
    28
    1
    13
    1
        5.6 - 6.0
    15
    16
    11
    1
    16
    2
        5.1 - 5.5
    7
    13
    7
    4
    10
    3
        4.7 - 5.0
    14
    17
    19
    22
    22
    14
        <= 5.6
    15
    14
    7
    42
    15
    50
        Missing
    0
    2
    0
    1
    4
    1
    No statistical analyses for this end point

    Secondary: Vaginal health index parameter epithelial mucosa

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    End point title
    		 Vaginal health index parameter epithelial mucosa
    End point description
    End point type
    Secondary
    End point timeframe
    At each visit: Visit 1 (Days 1), visit 2 (Day 22), visit 3 (Day 43)
    End point values
    		 Vagisan (PP) Day 1 Vagisan (PP) Day 43 Ovestin (PP) Day 1 Ovestin (PP) Day 43 Vagisan (PP) Day 22 Ovestin (PP) Day 22
    Number of subjects analysed
    80
    80
    71
    71
    80
    71
    Units: Number of patients
        Petechiae noted before contact
    0
    0
    3
    0
    0
    0
        Bleeds with light contact
    12
    3
    7
    0
    0
    0
        Bleeds with scraping
    10
    5
    4
    0
    7
    1
        Not friable, thin mucosa
    48
    56
    52
    20
    44
    21
        Not friable, normal mucosa
    10
    14
    5
    50
    25
    48
        Missing
    0
    2
    0
    1
    4
    1
    No statistical analyses for this end point

    Secondary: Vaginal health index parameter moisture

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    End point title
    		 Vaginal health index parameter moisture
    End point description
    End point type
    Secondary
    End point timeframe
    At each visit: Visit 1 (Days 1), visit 2 (Day 22), visit 3 (Day 43)
    End point values
    		 Vagisan (PP) Day 1 Vagisan (PP) Day 43 Ovestin (PP) Day 1 Ovestin (PP) Day 43 Vagisan (PP) Day 22 Ovestin (PP) Day 22
    Number of subjects analysed
    80
    80
    71
    71
    80
    71
    Units: Number of patients
        None, mucosa inflamed
    4
    0
    6
    0
    1
    1
        None, mucosa not inflamed
    17
    2
    13
    0
    0
    0
        Minimal
    37
    11
    29
    3
    10
    1
        Moderate
    16
    40
    21
    16
    40
    21
        Normal
    6
    25
    2
    51
    25
    47
        Missing
    0
    2
    0
    1
    4
    1
    No statistical analyses for this end point

    Secondary: Vaginal health index sum score

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    End point title
    		 Vaginal health index sum score
    End point description
    Scores of VHI subparameters: Overall Elasticity: None - 1, Poor - 2, Fair - 3, Good - 4, Excellent - 5 Fluid secretion type and consistency: None - 1, Scant, thin yellow - 2, Superficial, thin white - 3, Moderate, thin white - 4, Normal (white flocculent) - 5 pH: ≥ 6.1 - 1, 5.6–6.0 - 2, 5.1–5.5 - 3, 4.7–5.0 - 4, ≤ 4.6 - 5 Epithelial mucosa: Petechiae noted before contact - 1, Bleeds with light contact - 2, Bleeds with scraping - 3, Not friable, thin mucosa - 4, Not friable, normal mucosa - 5 Moisture: None, mucosa inflamed - 1, None, mucosa not inflamed - 2, Minimal - 3, Moderate - 4, Normal - 5 Each of the five criteria was graded from 1 (worst) to 5 (best) and then summed up. Range of VHI sum score: 5 - 25
    End point type
    Secondary
    End point timeframe
    At each visit: Visit 1 (Days 1), visit 2 (Day 22), visit 3 (Day 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    80 [33]
    71 [34]
    Units: VHI Score
    arithmetic mean (standard deviation)
        Day 1
    15.0 ± 4.4
    14.7 ± 4.1
        Day 22
    9.2 ± 3.2
    22.7 ± 2.6
        Day 43
    18.9 ± 0.3
    22.9 ± 2.5
    Notes
    [33] - n = 80 (D1); 76 (D22); 78 (D43)
    [34] - n = 71 (D1); 70 (D22); 70 (D43)
    No statistical analyses for this end point

    Secondary: AUC for vaginal health index parameter elasticity

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    End point title
    		 AUC for vaginal health index parameter elasticity
    End point description
    End point type
    Secondary
    End point timeframe
    Over all assessment time points: At each visit (Days 1, 22, 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    74
    69
    Units: Days
        arithmetic mean (standard deviation)
    151.0 ± 23.4
    168.6 ± 22.5
    No statistical analyses for this end point

    Secondary: AUC for vaginal health index parameter fluid secretion

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    End point title
    		 AUC for vaginal health index parameter fluid secretion
    End point description
    End point type
    Secondary
    End point timeframe
    Over all assessment time points: At each visit (Days 1, 22, 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    74
    69
    Units: Days
        arithmetic mean (standard deviation)
    152.1 ± 27.4
    170.4 ± 25.5
    No statistical analyses for this end point

    Secondary: AUC for vaginal health index parameter pH

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    End point title
    		 AUC for vaginal health index parameter pH
    End point description
    End point type
    Secondary
    End point timeframe
    Over all assessment time points: At each visit (Days 1, 22, 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    74
    69
    Units: Days
        arithmetic mean (standard deviation)
    122.2 ± 53.2
    169.2 ± 29.6
    No statistical analyses for this end point

    Secondary: AUC for vaginal health index parameter epithelial mucosa

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    End point title
    		 AUC for vaginal health index parameter epithelial mucosa
    End point description
    End point type
    Secondary
    End point timeframe
    Over all assessment time points: At each visit (Days 1, 22, 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    74
    69
    Units: Days
        arithmetic mean (standard deviation)
    169.4 ± 23.3
    186.1 ± 19.7
    No statistical analyses for this end point

    Secondary: AUC for vaginal health index parameter moisture

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    End point title
    		 AUC for vaginal health index parameter moisture
    End point description
    End point type
    Secondary
    End point timeframe
    Over all assessment time points: At each visit (Days 1, 22, 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    74
    69
    Units: Days
        arithmetic mean (standard deviation)
    163.3 ± 25.1
    177.6 ± 22.6
    No statistical analyses for this end point

    Secondary: AUC for vaginal health index sum score

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    End point title
    		 AUC for vaginal health index sum score
    End point description
    End point type
    Secondary
    End point timeframe
    Over all assessment time points: At each visit (Days 1, 22, 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    74
    69
    Units: Days
        arithmetic mean (standard deviation)
    758.0 ± 128.7
    872.0 ± 94.8
    No statistical analyses for this end point

    Secondary: Vaginal status of Lactobacillus flora

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    End point title
    		 Vaginal status of Lactobacillus flora
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 (Visit 1) and Day 43 (Visit 3)
    End point values
    		 Vagisan (PP) Day 1 Vagisan (PP) Day 43 Ovestin (PP) Day 1 Ovestin (PP) Day 43
    Number of subjects analysed
    80
    80
    71
    71
    Units: Number of patients
        Increased
    0
    1
    0
    0
        Normal
    22
    18
    16
    34
        Decreased
    58
    61
    55
    37
    No statistical analyses for this end point

    Secondary: Global judgment of the efficacy by the Investigator

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    End point title
    		 Global judgment of the efficacy by the Investigator
    End point description
    End point type
    Secondary
    End point timeframe
    On Visit 3 (Day 43, after 6 weeks of treatment)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    80
    71
    Units: Number of patients
        Very good
    19
    53
        Good
    48
    14
        Moderate
    10
    3
        Poor
    3
    1
    No statistical analyses for this end point

    Secondary: Global judgment of the efficacy by the patient

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    End point title
    		 Global judgment of the efficacy by the patient
    End point description
    End point type
    Secondary
    End point timeframe
    On Visit 3 (Day 43, after 6 weeks of treatment)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    80
    71
    Units: Number of patients
        Very good
    40
    55
        Good
    29
    12
        Moderate
    9
    4
        Poor
    2
    0
    No statistical analyses for this end point

    Secondary: Global judgment of the tolerability by the Investigator

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    End point title
    		 Global judgment of the tolerability by the Investigator
    End point description
    End point type
    Secondary
    End point timeframe
    On Visit 3 (Day 43, after 6 weeks of treatment)
    End point values
    		 Vagisan (SP) Ovestin (SP)
    Number of subjects analysed
    84
    78
    Units: Number of patients
        Very good
    58
    65
        Good
    21
    9
        Moderate
    3
    4
        Poor
    1
    0
        Missing
    1
    0
    No statistical analyses for this end point

    Secondary: Global judgment of the tolerability by the patient

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    End point title
    		 Global judgment of the tolerability by the patient
    End point description
    End point type
    Secondary
    End point timeframe
    On Visit 3 (Day 43, after 6 weeks of treatment)
    End point values
    		 Vagisan (SP) Ovestin (SP)
    Number of subjects analysed
    84
    78
    Units: Number of patients
        Very good
    56
    63
        Good
    17
    10
        Moderate
    7
    3
        Poor
    3
    2
        Missing
    1
    0
    No statistical analyses for this end point

    Secondary: Number of concomitant therapies at screening

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    End point title
    		 Number of concomitant therapies at screening
    End point description
    End point type
    Secondary
    End point timeframe
    At screening
    End point values
    		 Vagisan (SP) Ovestin (SP)
    Number of subjects analysed
    87
    85
    Units: Count
        Therapies
    72
    84
        Patients with any therapy
    44
    43
    No statistical analyses for this end point

    Secondary: Number of study participants that used any treatment for vulvovaginal dryness before study participation

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    End point title
    		 Number of study participants that used any treatment for vulvovaginal dryness before study participation
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 1 (Day 1)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    80
    71
    Units: Number of patients
        Yes
    16
    14
        No
    64
    57
    No statistical analyses for this end point

    Secondary: Satisfaction with treatment for vulvovaginal dryness before study participation

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    End point title
    		 Satisfaction with treatment for vulvovaginal dryness before study participation
    End point description
    Satisfaction with previous treatment in subgroup of patients that used treatment for vulvovaginal dryness before study participation
    End point type
    Secondary
    End point timeframe
    Visit 1 (Day 1)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    16
    14
    Units: Number of patients
        Very good
    1
    2
        Good
    5
    5
        Moderate
    6
    6
        Poor
    4
    1
    No statistical analyses for this end point

    Secondary: Urinary incontinence

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    End point title
    		 Urinary incontinence
    End point description
    The urinary incontinence was assessed by the patient: Visit 1: yes/no-question Visit 2 and Visit 3: improvement/worsening/no change Data reported for the subgroup of women suffering from urinary incontinence on Visit 1.
    End point type
    Secondary
    End point timeframe
    At each visit: Visit 1 (Day 1), Visit 2 (Day 22) and Visit 3 (Day 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    15
    15
    Units: Number of patients
        No change until visit 2, improvement until visit 3
    0
    1
        No change until visit 2, no change until visit 3
    14
    14
        No change until visit 2,worsening until visit 3
    1
    0
        Worsening until visit 2, improvement until visit 3
    0
    0
    No statistical analyses for this end point

    Secondary: Questionnaire about satisfaction with the test product

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    End point title
    		 Questionnaire about satisfaction with the test product
    End point description
    Question: "Were you satisfied with the preparation you used?"
    End point type
    Secondary
    End point timeframe
    Visit 3 (Day 43)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    80
    71
    Units: Number of patients
        Yes
    71
    67
        No
    5
    2
        I don't know
    4
    2
    No statistical analyses for this end point

    Secondary: Dose of the treatment with the test product (Vagisan only)

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    End point title
    		 Dose of the treatment with the test product (Vagisan only)
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 (Visit 1) to Day 43 (Visit 3)
    End point values
    		 Vagisan (PP)
    Number of subjects analysed
    80
    Units: Sum of product applications during trial
    arithmetic mean (standard deviation)
        1/2 applicator
    35 ± 11
        More
    1 ± 4
        Less
    5 ± 10
        Missing
    0 ± 1
    No statistical analyses for this end point

    Secondary: Frequency of the treatment with the test product

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    End point title
    		 Frequency of the treatment with the test product
    End point description
    End point type
    Secondary
    End point timeframe
    From Day 1 (Visit 1) to Day 43 (Visit 3)
    End point values
    		 Vagisan (PP) Ovestin (PP)
    Number of subjects analysed
    80
    71
    Units: Sum of product applications during trial
    arithmetic mean (standard deviation)
        Vaginal application
    41 ± 2.7
    26.5 ± 0.9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 - 43
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Vagisan (SP)
    Reporting group description
    		 -

    Reporting group title
    Ovestin (SP)
    Reporting group description
    		 -

    Serious adverse events
    		 Vagisan (SP) Ovestin (SP)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 85 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Vagisan (SP) Ovestin (SP)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    33 / 87 (37.93%)
    46 / 85 (54.12%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    3
    Hypertension
         subjects affected / exposed
    2 / 87 (2.30%)
    3 / 85 (3.53%)
         occurrences all number
    2
    3
    Surgical and medical procedures
    Tooth extraction
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    Pyrexia
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 85 (0.00%)
         occurrences all number
    5
    0
    Reproductive system and breast disorders
    Breast pain
         subjects affected / exposed
    0 / 87 (0.00%)
    3 / 85 (3.53%)
         occurrences all number
    0
    5
    Female sexual arousal disorder
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Genital burning sensation
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Genital haemorrhage
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Uterine spasm
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Vaginal discharge
         subjects affected / exposed
    2 / 87 (2.30%)
    4 / 85 (4.71%)
         occurrences all number
    2
    7
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 85 (1.18%)
         occurrences all number
    2
    1
    Vulvovaginal burning sensation
         subjects affected / exposed
    5 / 87 (5.75%)
    9 / 85 (10.59%)
         occurrences all number
    7
    9
    Vulvovaginal discomfort
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Vulvovaginal erythema
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Vulvovaginal pain
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Vulvovaginal pruritus
         subjects affected / exposed
    2 / 87 (2.30%)
    5 / 85 (5.88%)
         occurrences all number
    5
    5
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 87 (2.30%)
    2 / 85 (2.35%)
         occurrences all number
    2
    2
    Dysphonia
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Sleep disorder
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    Foot fracture
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Tooth fracture
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Cardiovascular insufficiency
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Palpitations
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Tachycardia
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    8 / 87 (9.20%)
    8 / 85 (9.41%)
         occurrences all number
    11
    14
    Migraine
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 85 (1.18%)
         occurrences all number
    1
    3
    Neuralgia
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    3
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Dry eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Macular degeneration
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 87 (3.45%)
    1 / 85 (1.18%)
         occurrences all number
    4
    1
    Abdominal pain lower
         subjects affected / exposed
    0 / 87 (0.00%)
    5 / 85 (5.88%)
         occurrences all number
    0
    5
    Abdominal pain upper
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 85 (2.35%)
         occurrences all number
    1
    2
    Dry mouth
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Dyspepsia
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Nausea
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 85 (0.00%)
         occurrences all number
    3
    0
    Toothache
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Pruritus
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Pollakiuria
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 87 (2.30%)
    1 / 85 (1.18%)
         occurrences all number
    2
    1
    Back pain
         subjects affected / exposed
    2 / 87 (2.30%)
    3 / 85 (3.53%)
         occurrences all number
    2
    3
    Limb discomfort
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    0 / 87 (0.00%)
    3 / 85 (3.53%)
         occurrences all number
    0
    3
    Musculoskeletal pain
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Infections and infestations
    Anal fungal infection
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Candida infection
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Hordeolum
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    7 / 87 (8.05%)
    12 / 85 (14.12%)
         occurrences all number
    7
    12
    Sinusitis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Vaginal infection
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Vulvitis
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1

    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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