Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A double-blind, placebo controlled single centre trial to evaluate the dose-relationship of the effects of vaginally administered oxytocin on the vaginal mucosal membrane in postmenopausal women

    Summary
    EudraCT number
    		 2011-005465-20
    Trial protocol
    		 SE  
    Global end of trial date
    08 Feb 2013

    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)
    		 2011-005465-20, OXYPEP002 Clinical Trial Report, Summary

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    OXYPEP002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01987804
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Peptonic Medical
    Sponsor organisation address
    Gustavslundsvägen 143, Bromma, Sweden, 16751
    Public contact
    Dan Markusson, PeP-Tonic Medical AB, +46 0768550200, dan.markusson@peptonicmedical.se
    Scientific contact
    Dan Markusson, PeP-Tonic Medical AB, +46 0768550200, 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
    31 Aug 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Jul 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Feb 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to investigate the dose-relationship of topical Vagitocin on the vaginal mucosal membrane.
    Protection of trial subjects
    The trial was carried out in accordance with: - The Guidelines of the World Medical Association (WMA) Declaration of Helsinki (as amended by the 59th WMA General Assembly, Seoul, October 2008) - The Guidelines of Good Clinical Practice (GCP) (CPMP/ICH/135/95) - Explanatory Note and Comments to the above, issued as CPMP/768/9. - EU Directive (2005/28/EG, April 2005) - LVFS 2003:6 (Läkemedelsverkets Författningssamling, 2003-06-26); replaced by LVFS 2011:19, 2012-02-01 - Demands of national drug and data protection laws and other applicable regulatory requirements The trial was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki that are consistent with International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) and applicable regulatory requirements. Informed consent was obtained from all patients, at the Baseline visit, prior to initiation of the trial.
    Background therapy
    		 Relevant medication history (prior medications), as judged by the investigator, for a month prior to trial start, was to be recorded in the e-CRF. Prescription medications, over-the-counter (OTC) medications, and herbal products were to be asked for. The investigator or designee was to assess changes in concomitant medications throughout the trial by asking the patient at each visit. Any changes reported by the patient were to be recorded in the e- CRF. Usage of any sex steroids, including phytoestrogens, hormonal intra-uterine device or herbal medicinal products with known estrogenic effects was not permitted during the trial. Usage of any lubricant and/or pharmaceutical agents for symptomatic treatment of vaginal atrophy, including herbal drugs, was not permitted during the trial.
    Evidence for comparator
    		 Not applicable.
    Actual start date of recruitment
    17 Jan 2012
    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: 64
    Worldwide total number of subjects
    64
    EEA total number of subjects
    64
    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)
    47
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Start of recruitment period: 2012-02-15 End of recrutiment period: 2012-04-27 Territory: Sweden

    Pre-assignment
    Screening details
    		 67 patients were screened at the investigational centre and of these, 64 patients (24 each in Vagitocin 100 IU and Vagitocin 400 IU treatment groups and 16 in the placebo group) were randomised.

    Period 1
    Period 1 title
    Overall trial (overall period)
    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 trial, and therefore, the allocation of the treatment groups was not known to the patient, the staff at the centre or any other trial personnel (e.g. the sponsor’s or CRO’s representatives), until after the database was locked. Blinding was accomplished by ensuring that the active substance and placebo were of identical appearance (clear gel), packaging and labelling, with the only difference being the patient identification number/randomisation number on the label.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Vagitocin 100 IU
    Arm description
    		 The gel formulation containing 100 IU of oxytocin/ml.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vagitocin 100 IU
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Vaginal use
    Dosage and administration details
    The IMP was to be topically administered on the vaginal mucosa, once daily during seven weeks.

    Arm title
    		 Vagitocin 400 IU
    Arm description
    		 The gel formulation containing 400 IU of oxytocin/ml.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vagitocin 400 IU
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Vaginal use
    Dosage and administration details
    The IMP was to be topically administered on the vaginal mucosa, once daily during seven weeks.

    Arm title
    		 Placebo
    Arm description
    		 The gel formulation containing no active substance.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Vaginal use
    Dosage and administration details
    The IMP was to be topically administered on the vaginal mucosa, once daily during seven weeks.

    Number of subjects in period 1
    		Vagitocin 100 IU Vagitocin 400 IU Placebo
    Started
    24
    24
    16
    Completed
    18
    23
    14
    Not completed
    6
    1
    2
         Adenocarcinoma
    1
    -
    -
         Physician decision
    3
    -
    1
         Consent withdrawn by subject
    1
    1
    -
         Adverse event, non-fatal
    1
    -
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Vagitocin 100 IU
    Reporting group description
    		 The gel formulation containing 100 IU of oxytocin/ml.

    Reporting group title
    Vagitocin 400 IU
    Reporting group description
    		 The gel formulation containing 400 IU of oxytocin/ml.

    Reporting group title
    Placebo
    Reporting group description
    		 The gel formulation containing no active substance.

    Reporting group values
    		 Vagitocin 100 IU Vagitocin 400 IU Placebo Total
    Number of subjects
    		 24 24 16 64
    Age categorical
    Units: Subjects
    Age continuous
    => 40 years of age
    Units: years
        arithmetic mean (standard deviation)
    		 62.0 ( 5.7 ) 61.1 ( 5.3 ) 63.2 ( 5.8 ) -
    Gender categorical
    Women aged 40 and above
    Units: Subjects
        Female
    		 24 24 16 64
    Ethnicity
    Ethnic group
    Units: Subjects
        African Descent
    		 0 0 0 0
        Asian or Pacific Islanders
    		 0 0 0 0
        Caucasian
    		 24 24 16 64
        Mixed / Multi-racial
    		 0 0 0 0
        Other
    		 0 0 0 0
    Height
    Height (cm)
    Units: Centimeter
        arithmetic mean (standard deviation)
    		 166.0 ( 6.3 ) 165.5 ( 7.4 ) 164.4 ( 5.3 ) -
    Weight
    Weight (kg)
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 62.94 ( 6.60 ) 66.58 ( 12.02 ) 64.68 ( 7.84 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Vagitocin 100 IU
    Reporting group description
    		 The gel formulation containing 100 IU of oxytocin/ml.

    Reporting group title
    Vagitocin 400 IU
    Reporting group description
    		 The gel formulation containing 400 IU of oxytocin/ml.

    Reporting group title
    Placebo
    Reporting group description
    		 The gel formulation containing no active substance.

    Primary: Change in percentage points of superficial cells from Baseline visit to 7 weeks of treatment.

    		 Close Top of page
    End point title
    		 Change in percentage points of superficial cells from Baseline visit to 7 weeks of treatment.
    End point description
    The primary endpoint was the change in percentage points of superficial cells from Baseline visit (Visit 1) to 7 weeks of treatment (Visit 3).
    End point type
    Primary
    End point timeframe
    From baseline to 7 weeks of treatment
    End point values
    		 Vagitocin 100 IU Vagitocin 400 IU Placebo
    Number of subjects analysed
    24 [1]
    24 [2]
    16 [3]
    Units: percentage points
        median (full range (min-max))
    0.55 (-1.0 to 26.7)
    0.20 (-3.5 to 74.1)
    0.30 (-4.4 to 8.1)
    Notes
    [1] - Full analysis set
    [2] - Full analysis set
    [3] - Full analysis set
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Each active treatment group was separately compared to placebo for superiority in a hierarchical manner. First the superiority of the Vagitocin 400 IU group was tested versus the placebo group and only if the superiority was established, the superiority of the Vagitocin 100 IU group against the placebo group was tested.
    Comparison groups
    Vagitocin 100 IU v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 < 0.05 [5]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [4] - No adjustment to the type-1 error was made as it was protected by the hierarchical structure of analysis. The primary efficacy endpoint was to be analysed using ANCOVA with treatment as factor and baseline value as covariate. However, the assumption of normality was not met when tested using the Anderson-Darling test. As a result ANCOVA model on the ranked data was fitted in order to compare the treatment effects.
    [5] - All tests were to be two-sided and performed at the 5% significance level if not otherwise specified. When reporting the results of significance tests p-values were to be reported.
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Each active treatment group was separately compared to placebo for superiority in a hierarchical manner. First the superiority of the Vagitocin 400 IU group was tested versus the placebo group and only if the superiority was established, the superiority of the Vagitocin 100 IU group against the placebo group was tested.
    Comparison groups
    Vagitocin 400 IU v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 < 0.05 [7]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [6] - No adjustment to the type-1 error was made as it was protected by the hierarchical structure of analysis. The primary efficacy endpoint was to be analysed using ANCOVA with treatment as factor and baseline value as covariate. However, the assumption of normality was not met when tested using the Anderson-Darling test. As a result ANCOVA model on the ranked data was fitted in order to compare the treatment effects.
    [7] - All tests were to be two-sided and performed at the 5% significance level if not otherwise specified. When reporting the results of significance tests p-values were to be reported.
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Each active treatment group was separately compared to placebo for superiority in a hierarchical manner. First the superiority of the Vagitocin 400 IU group was tested versus the placebo group and only if the superiority was established, the superiority of the Vagitocin 100 IU group against the placebo group was tested.
    Comparison groups
    Vagitocin 400 IU v Vagitocin 100 IU
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [8]
    P-value
    		 < 0.05 [9]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [8] - No adjustment to the type-1 error was made as it was protected by the hierarchical structure of analysis. The primary efficacy endpoint was to be analysed using ANCOVA with treatment as factor and baseline value as covariate. However, the assumption of normality was not met when tested using the Anderson-Darling test. As a result ANCOVA model on the ranked data was fitted in order to compare the treatment effects.
    [9] - All tests were to be two-sided and performed at the 5% significance level if not otherwise specified. When reporting the results of significance tests p-values were to be reported.

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Any apparent side effects experienced by the patient were to be assessed from the time of the first administration of IMP and throughout the course of the entire trial.
    Adverse event reporting additional description
    The occurrence of an AE may come to the attention of trial personnel during trial visits and interviews of a trial recipient presenting for medical care, or upon review by a trial monitor who was scrutinising relevant source data.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Vagitocin 100 IU
    Reporting group description
    		 The gel formulation containing 100 IU of oxytocin/ml.

    Reporting group title
    Vagitocin 400 IU
    Reporting group description
    		 The gel formulation containing 400 IU of oxytocin/ml.

    Reporting group title
    Placebo
    Reporting group description
    		 The gel formulation containing no active substance.

    Serious adverse events
    		 Vagitocin 100 IU Vagitocin 400 IU Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Vagitocin 100 IU Vagitocin 400 IU Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 24 (33.33%)
    9 / 24 (37.50%)
    8 / 16 (50.00%)
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Reproductive system and breast disorders
    Vaginal discharge
         subjects affected / exposed
    2 / 24 (8.33%)
    2 / 24 (8.33%)
    2 / 16 (12.50%)
         occurrences all number
    2
    2
    2
    Pelvic pain
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 24 (4.17%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    2 / 24 (8.33%)
    3 / 24 (12.50%)
    0 / 16 (0.00%)
         occurrences all number
    2
    4
    0
    Influenza
         subjects affected / exposed
    2 / 24 (8.33%)
    1 / 24 (4.17%)
    1 / 16 (6.25%)
         occurrences all number
    2
    1
    1
    Vaginal infection
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 24 (4.17%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Feb 2012
    The percentage of superficial cells, the levels of FSH plasma levels and 17β-estradiol levels at the Baseline visit were the critical criteria to determine whether the patients were suitable for the trial or not. Exclusion criteria number 4 was judged to be redundant. Exclusion criteria number 4 (Vaginal pH ≤ 5.0.) removed.
    17 Apr 2012
    The vaginal biopsy from Visit 2 was removed, since it was believed to be inconvenient for both the site staff and the patients. After discussions with the sponsor and the site staff it was concluded that biopsies collected at Baseline and Visit 3 would be sufficient to obtain the desired efficacy results. The variable had no impact on the safety of the patients. Vaginal biopsy at Visit 2 removed. Vaginal biopsies to be collected from 32 patients at the Baseline visit and at Visit 3.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 02 05:56:40 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA