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    Clinical Trial Results:
    VAGINAL PRASTERONE in the treatment of VAGINAL ATROPHY IN PATIENTS WITH BREAST CANCER TREATMENT WITH AROMATASE INHIBITORS (VIBRA STUDY)

    Summary
    EudraCT number
    		 2020-001077-79
    Trial protocol
    		 ES  
    Global end of trial date
    30 Dec 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 May 2026
    First version publication date
    28 May 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HCB/2020/0212
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04705883
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundació Clínic Recerca Biomèdica
    Sponsor organisation address
    C/ Villarroel 170, Barcelona, Spain,
    Public contact
    Secretaria de Ginecologia Clínic, Fundació Clínic Recerca Biomèdica, 34 392275436, secgine@clinic.cat
    Scientific contact
    Secretaria de Ginecologia Clínic, Fundació Clínic Recerca Biomèdica, 34 392275436, secgine@clinic.cat
    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
    01 Dec 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Nov 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Dec 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Verify a clinical improvement of AVV without increasing levels of ultrasensitive blood estradiol in breast cancer survivors treated with aromatase inhibitors by administering vaginal prasterone.
    Protection of trial subjects
    The protection of trial subjects was ensured through several measures. The study was conducted in accordance with the principles of the Declaration of Helsinki and complied with applicable data protection regulations. The protocol was reviewed and approved by the Ethics Committee of Hospital Clínic of Barcelona (approval code: HCB/2020/021). All participants provided written informed consent prior to inclusion. Only breast cancer survivors fulfilling strict inclusion and exclusion criteria were enrolled. Safety was closely monitored throughout the study period, including serial clinical evaluations and repeated measurements of ultrasensitive serum estradiol levels at each follow‑up visit. Adverse events were actively recorded during all visits. Given the low‑risk nature of the intervention, the pilot design, and the small sample size, no Independent Data Monitoring Committee was established.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    10
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 10
    Number of subjects completed
    		 10

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable. Open-label, single-arm pilot study.

    Arms
    Arm title
    		 Prasterone
    Arm description
    		 Single-arm treatment with vaginal prasterone (DHEA)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prasterone
    Investigational medicinal product code
    Other name
    DHEA, Intrarosa
    Pharmaceutical forms
    Vaginal capsule, soft
    Routes of administration
    Vaginal use
    Dosage and administration details
    Prasterone 6.5 mg administered vaginally as a vaginal ovule. One ovule was used daily during the first month, followed by one ovule every other day for the remaining five months of treatment.

    Number of subjects in period 1
    		Prasterone
    Started
    10
    Completed
    7
    Not completed
    3
         Consent withdrawn by subject
    1
         COVID19 pandemic limitaons
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Prasterone
    Reporting group description
    		 Single-arm treatment with vaginal prasterone (DHEA)

    Reporting group values
    		 Prasterone Total
    Number of subjects
    		 10 10
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.8 ( 6.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Prasterone
    Reporting group description
    		 Single-arm treatment with vaginal prasterone (DHEA)

    Primary: Serum estradiol levels

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    End point title
    		 Serum estradiol levels [1]
    End point description
    Change in ultrasensitive serum estradiol levels from baseline to 6 months of treatment with vaginal prasterone in breast cancer survivors treated with aromatase inhibitors.
    End point type
    Primary
    End point timeframe
    Baseline to Month 6
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Serum estradiol levels at baseline and month 6 were analysed using a paired Wilcoxon signed-rank test. No statistically significant change was observed (two-sided p=0.9136)
    End point values
    		 Prasterone
    Number of subjects analysed
    7
    Units: pg/mL
        arithmetic mean (standard deviation)
    4.3 ( 7.5 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From first administration of prasterone until end of 6-month follow-up.
    Adverse event reporting additional description
    No treatment-related local adverse events were reported during the study. Three participants discontinued the study: one due to safety concerns despite partial symptom improvement, and two due to COVID-19-related follow-up limitations.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Prasterone
    Reporting group description
    		 Single-arm treatment with vaginal prasterone (DHEA)

    Serious adverse events
    		 Prasterone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Prasterone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious adverse events related to prasterone were observed or recorded during the study follow-up period. Therefore, no non-serious adverse events are reported

    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.
    This was a small open-label pilot study including only 10 participants, with 7 completing the 6-month follow-up. The study lacked a control group and had limited statistical power. Hormone measurements were performed using immunoassay techniques that

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/35343852
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    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.

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