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    Clinical Trial Results:
    A Phase 2b, Double-blind, Randomized, Parallel, Placebo-Controlled Study to Evaluate the 12-week Efficacy of Vagitocin in Postmenopausal Women with Symptoms of Vulvovaginal Atrophy

    Summary
    EudraCT number
    2016-000158-36
    Trial protocol
    SE  
    Global end of trial date
    03 May 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    08 Nov 2020
    First version publication date
    08 Nov 2020
    Other versions
    Summary report(s)
    2016-000158-36, OXYPEP202, Study Report Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    OXYPEP202
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    PEPTONIC medical AB
    Sponsor organisation address
    Gustavslundsvägen 143, Bromma, Sweden, 16751
    Public contact
    Dan Markusson, PEPTONIC medical AB, 46 853020110, dan.markusson@peptonicmedical.se
    Scientific contact
    Dan Markusson, PEPTONIC medical AB, 46 853020110, dan.markusson@peptonicmedical.se
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Jun 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 May 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of Vagitocin in reducing the severity of the most bothersome symptom of vulvovaginal atrophy (VVA) associated with menopause after 12 weeks of treatment.
    Protection of trial subjects
    The study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki that are consistent with International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP) and applicable regulatory requirements.
    Background therapy
    Prior and concomitant medications was collected at Screening and throughout the study. Any hormonal therapy taken within 1 year prior to the Screening visit was recorded as a prior medication with the corresponding indication. Any other medication and dietary supplements taken within 12 weeks prior to the initial administration of the Screening visit were also recorded as prior medications. Concomitant medications included any medication including OTC products and herbal or nutritional supplements/medications taken during the active study period. The investigator or designee assessed changes in concomitant medications throughout the study by asking the subject at each visit and, when appropriate, during
    Evidence for comparator
    -
    Actual start date of recruitment
    02 May 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
    Sweden: 202
    Worldwide total number of subjects
    202
    EEA total number of subjects
    202
    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)
    193
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    First subject was screened on 2016-04-19. A total of 211 women were screened. 161 were randomised in the main part of the study, which was conducted at 3 centres in Sweden. Last subject last visit was 2017-02-15

    Pre-assignment
    Screening details
    Patients fulfilling all of the inclusion criteria and none of the exclusion criteria were to be asked to participate in the trial. A total of 211 women were screened and 161 were randomised in the main part of the study. Forty-one subjects were screen failures.

    Period 1
    Period 1 title
    Main part
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    This was a double-blind study, and therefore, subjects, the investigator, study site personnel, and Sponsor personnel involved with data review and analysis, remained blinded to study treatment throughout the study. The packaging of Vagitocin and placebo was identical in appearance to maintain adequate blinding of study subjects and investigators. Neither the subject nor the investigator could identify the treatment from the packaging or label of the IMP..

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Vagitocin 400 IU
    Arm description
    Vagitocin 400 IU vaginal gel
    Arm type
    Experimental

    Investigational medicinal product name
    Vagitocin 400 IU vaginal gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Vaginal gel
    Routes of administration
    Vaginal use
    Dosage and administration details
    Vagitocin 400 IU/g vaginal gel, 1 mL administered once daily for 12 weeks.

    Arm title
    Placebo
    Arm description
    Placebo vaginal gel
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Vaginal gel
    Routes of administration
    Vaginal use
    Dosage and administration details
    Vaginal gel (placebo), 1 mL administered once daily for 12 weeks.

    Number of subjects in period 1 [1]
    Vagitocin 400 IU Placebo
    Started
    81
    80
    Completed
    78
    79
    Not completed
    3
    1
         Adverse event, non-fatal
    3
    -
         Consent withdrawn by subject
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The study includes 2 parts, the main part and the exploratory part. Subjects were included in either the main part or the exploratory part, not in both parts. Thus, the exploratory part is not a continuation of the main part but a separate part. The total number of subjects in the study (202) includes subjects from both parts of the study (main part 161 subjects and 41 subjects).
    Period 2
    Period 2 title
    Exploratory part
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Monitor, Data analyst, Carer, Assessor, Subject
    Blinding implementation details
    This was a double-blind study, and therefore, subjects, the investigator, study site personnel, and Sponsor personnel involved with data review and analysis, remained blinded to study treatment throughout the study. The packaging of Vagitocin and placebo was identical in appearance to maintain adequate blinding of study subjects and investigators. Neither the subject nor the investigator could identify the treatment from the packaging or label of the IMP.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Vagitocin 400 IU
    Arm description
    Vagitocin 400 IU vaginal gel
    Arm type
    Experimental

    Investigational medicinal product name
    Vagitocin 400 IU vaginal gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Vaginal gel
    Routes of administration
    Vaginal use
    Dosage and administration details
    Vagitocin 400 IU/g vaginal gel, 1 mL administered once daily for 12 weeks.

    Arm title
    Placebo
    Arm description
    Placebo vaginal gel
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Vaginal gel
    Routes of administration
    Vaginal use
    Dosage and administration details
    Vaginal gel (placebo), 1 mL administered once daily for 12 weeks.

    Number of subjects in period 2 [2]
    Vagitocin 400 IU Placebo
    Started
    31
    10
    Completed
    30
    9
    Not completed
    1
    1
         Adverse event, non-fatal
    1
    1
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: The study includes 2 parts, the main part and the exploratory part. Subjects were included in either the main part or the exploratory part, not in both parts. Thus, the exploratory part is not a continuation of the main part but a separate part. The total number of subjects in the study (202) includes subjects from both parts of the study (main part 161 subjects and 41 subjects).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Main part
    Reporting group description
    Females aged 40-65 years who were either postmenopausal or had undergone surgical bilateral oophorectomy, with ≤5% superficial cells in vaginal smear cytology, a vaginal pH >5.0, a body mass index (BMI) ≤32 kg/m2, an endometrial thickness of <4 mm and one moderate to severe VVA symptom but who were otherwise in good health and had provided signed informed consent were considered eligible to participate in the study.

    Reporting group values
    Main part Total
    Number of subjects
    161 161
    Age categorical
    Females aged 40-65 years who were either postmenopausal or had undergone surgical bilateral oophorectomy, with ≤5% superficial cells in vaginal smear cytology, a vaginal pH >5.0, a body mass index (BMI) ≤32 kg/m2, an endometrial thickness of <4 mm and one moderate to severe VVA symptom but who were otherwise in good health and had provided signed informed consent were considered eligible to participate in the study.
    Units: Subjects
        Adults (18-64 years)
    150 150
        From 65-84 years
    11 11
    Age continuous
    Females aged 40-65 years who were either postmenopausal or had undergone surgical bilateral oophorectomy, with ≤5% superficial cells in vaginal smear cytology, a vaginal pH >5.0, a body mass index (BMI) ≤32 kg/m2, an endometrial thickness of <4 mm and one moderate to severe VVA symptom but who were otherwise in good health and had provided signed informed consent were considered eligible to participate in the study.
    Units: years
        arithmetic mean (standard deviation)
    58.3 ± 3.5 -
    Gender categorical
    Females aged 40-65 years
    Units: Subjects
        Female
    161 161
    Race
    Units: Subjects
        Caucasian
    159 159
        Other
    2 2
    Use of tobacco
    Units: Subjects
        Never
    93 93
        Current
    7 7
        Former
    60 60
        Missing
    1 1
    Alcohol consumption
    Units: Subjects
        Never
    17 17
        Current
    144 144
    Height
    Units: cm
        arithmetic mean (standard deviation)
    165.9 ± 5.8 -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    69.68 ± 9.88 -
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    25.31 ± 3.28 -

    End points

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    End points reporting groups
    Reporting group title
    Vagitocin 400 IU
    Reporting group description
    Vagitocin 400 IU vaginal gel

    Reporting group title
    Placebo
    Reporting group description
    Placebo vaginal gel
    Reporting group title
    Vagitocin 400 IU
    Reporting group description
    Vagitocin 400 IU vaginal gel

    Reporting group title
    Placebo
    Reporting group description
    Placebo vaginal gel

    Subject analysis set title
    Vagitocin 40 IU, baseline 2 (Moderate)
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    VVA symptoms that has been self-identified by the subject as being the most bothersome to her at baseline, shift from baseline (mITT population. Main part)

    Subject analysis set title
    Vagitocin 40 IU, baseline 3 (Severe)
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    VVA symptoms that has been self-identified by the subject as being the most bothersome to her at baseline, shift from baseline (mITT population. Main part)

    Subject analysis set title
    Placebo , baseline 2 (Moderate)
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    VVA symptoms that has been self-identified by the subject as being the most bothersome to her at baseline, shift from baseline (mITT population. Main part)

    Subject analysis set title
    Placebo , baseline 3 (Severe)
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    VVA symptoms that has been self-identified by the subject as being the most bothersome to her at baseline, shift from baseline (mITT population. Main part)

    Primary: Change from baseline to Week 12 in severity of the VVA symptom that has been self-identified by the subject as being the MBS to her at baseline.

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    End point title
    Change from baseline to Week 12 in severity of the VVA symptom that has been self-identified by the subject as being the MBS to her at baseline.
    End point description
    Change from baseline to Week 12 in severity of the VVA symptom that has been self-identified by the subject as being the MBS to her at baseline. Severity was defined as; 0=None, 1 = Mild, 2 = Moderate, 3=Severe
    End point type
    Primary
    End point timeframe
    Change from baseline to Week 12
    End point values
    Vagitocin 400 IU Placebo Vagitocin 40 IU, baseline 2 (Moderate) Vagitocin 40 IU, baseline 3 (Severe) Placebo , baseline 2 (Moderate) Placebo , baseline 3 (Severe)
    Number of subjects analysed
    0 [1]
    0 [2]
    31
    48
    43
    35
    Units: percentage
    number (not applicable)
        0=None
    14
    9
    19
    6
        1=Mild
    8
    6
    17
    12
        2=Moderate
    6
    20
    4
    6
        3=Severe
    3
    13
    3
    11
        Missing
    0
    0
    0
    0
    Notes
    [1] - Endpoint reported on other reporting groups
    [2] - Endpoint reported on other reporting groups
    Statistical analysis title
    Statistical analysis, Main part
    Statistical analysis description
    A Cochran-Mantel-Haenszel test using modified ridit scores (Wilcoxon rank sum test) adjusted for the baseline value was performed.
    Comparison groups
    Vagitocin 40 IU, baseline 2 (Moderate) v Vagitocin 40 IU, baseline 3 (Severe) v Placebo , baseline 2 (Moderate) v Placebo , baseline 3 (Severe)
    Number of subjects included in analysis
    157
    Analysis specification
    Pre-specified
    Analysis type
    superiority [3]
    P-value
    < 0.05
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [3] - The study was to be considered successful if the two-sided p-value in the statistical analysis of the primary endpoint for the main study was less than 0.0500 and in favour of the active treatment.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AE reporting from signed informed consent to study completion (Approximately 14 weeks)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Vagitocin 400 IU, main part
    Reporting group description
    Vagitocin 400 IU vaginal gel,

    Reporting group title
    Placebo, main part
    Reporting group description
    Placebo vaginal gel

    Reporting group title
    Vagitocin 400 IU, exploratory part
    Reporting group description
    -

    Reporting group title
    Placebo, exploratory part
    Reporting group description
    -

    Serious adverse events
    Vagitocin 400 IU, main part Placebo, main part Vagitocin 400 IU, exploratory part Placebo, exploratory part
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 80 (1.25%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 80 (1.25%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 80 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Rib fracture
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 80 (1.25%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Vagitocin 400 IU, main part Placebo, main part Vagitocin 400 IU, exploratory part Placebo, exploratory part
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 81 (24.69%)
    9 / 80 (11.25%)
    7 / 31 (22.58%)
    6 / 10 (60.00%)
    Investigations
    Biopsy endometrium normal
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 80 (0.00%)
    0 / 31 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 80 (0.00%)
    0 / 31 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    0
    1
    Reproductive system and breast disorders
    Vaginal discharge
         subjects affected / exposed
    8 / 81 (9.88%)
    4 / 80 (5.00%)
    2 / 31 (6.45%)
    1 / 10 (10.00%)
         occurrences all number
    8
    4
    2
    1
    Vaginal odour
         subjects affected / exposed
    2 / 81 (2.47%)
    2 / 80 (2.50%)
    2 / 31 (6.45%)
    2 / 10 (20.00%)
         occurrences all number
    5
    2
    2
    2
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 80 (0.00%)
    0 / 31 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    5 / 81 (6.17%)
    2 / 80 (2.50%)
    1 / 31 (3.23%)
    1 / 10 (10.00%)
         occurrences all number
    6
    2
    1
    1
    Influenza
         subjects affected / exposed
    4 / 81 (4.94%)
    1 / 80 (1.25%)
    1 / 31 (3.23%)
    2 / 10 (20.00%)
         occurrences all number
    4
    1
    1
    2
    Nasopharyngitis
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 80 (0.00%)
    1 / 31 (3.23%)
    2 / 10 (20.00%)
         occurrences all number
    0
    0
    1
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Aug 2016
    There was one substantial amendment to the clinical study protocol during the study, which resulted in the removal of an inclusion criterion and in the update of the vulvovaginal atrophy (VVA) symptoms self-assessment questionnaire.

    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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