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    Clinical Trial Results:
    A randomized, double-blind, parallel-group, multicenter Phase 2b study to assess the efficacy and safety of two different doses of vilaprisan (BAY 1002670) versus placebo in women with symptomatic endometriosis

    Summary
    EudraCT number
    		 2013-004768-72
    Trial protocol
    		 AT   FI   DK   SE   ES   DE   HU   BG   CZ   IT  
    Global end of trial date
    26 Nov 2020

    Results information
    Results version number
    		 v2(current)
    This version publication date
    08 Apr 2023
    First version publication date
    11 Nov 2021
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Update needed.

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY1002670/15792
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03573336
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bayer
    Sponsor organisation address
    Kaiser-Wilhelm-Allee, Leverkusen, Germany, D-51368
    Public contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.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
    26 Nov 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Nov 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    With the implementation of protocol version 4.0 dated 11-Dec-2018, no further recruitment was possible. With the data available from subjects recruited before the temporary pause the objectives above cannot be reached. Safety evaluations including the added safety evaluations of the endometrium, adrenal glands, bone, and skin may add to the understanding of the safety of vilaprisan. The original Primary objective was to assess efficacy of two doses of vilaprisan compared to placebo in women with symptomatic endometriosis. The original secondary objective was to evaluate the safety and tolerability of two different doses of vilaprisan in women with symptomatic endometriosis.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Only after the subject voluntarily signed the informed consent form was he/she able to enter the study. If the subject was not capable of providing a signature, an oral statement of consent could have been given in the presence of a witness. Each subject was assured of the right to withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Jul 2018
    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
    Austria: 6
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Finland: 1
    Worldwide total number of subjects
    8
    EEA total number of subjects
    7
    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)
    8
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study was conducted at 7 study centers worldwide, between 04-Jul-2018 (first participant first visit) and 26-Nov-2020 (last participant last visit).

    Pre-assignment
    Screening details
    		 With the implementation of protocol version 4.0 dated 11-Dec-2018, no new subjects were enrolled. The objectives of this study cannot be reached as only limited data is available from subjects recruited before the treatment stopped. Overall, 48 participants were screened, of whom 8 participants were randomized and received the study treatment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Vilaprisan (BAY1002670) 2 mg
    Arm description
    		 Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 2 mg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vilaprisan
    Investigational medicinal product code
    BAY1002670
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One 2 mg vilaprisan tablet once daily orally for 24 weeks

    Arm title
    		 Vilaprisan (BAY1002670) 4 mg
    Arm description
    		 Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 4 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vilaprisan
    Investigational medicinal product code
    BAY1002670
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One 4 mg vilaprisan tablet once daily orally for 24 weeks

    Arm title
    		 Placebo
    Arm description
    		 Premenopausal women 18 years and older with endometriosis received placebo.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One placebo tablet matching vilaprisan once daily orally for 24 weeks

    Number of subjects in period 1
    		Vilaprisan (BAY1002670) 2 mg Vilaprisan (BAY1002670) 4 mg Placebo
    Started
    2
    4
    2
    Treated
    2
    4
    2
    Completed
    0
    0
    0
    Not completed
    2
    4
    2
         Study terminated
    2
    4
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Vilaprisan (BAY1002670) 2 mg
    Reporting group description
    		 Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 2 mg.

    Reporting group title
    Vilaprisan (BAY1002670) 4 mg
    Reporting group description
    		 Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 4 mg

    Reporting group title
    Placebo
    Reporting group description
    		 Premenopausal women 18 years and older with endometriosis received placebo.

    Reporting group values
    		 Vilaprisan (BAY1002670) 2 mg Vilaprisan (BAY1002670) 4 mg Placebo Total
    Number of subjects
    		 2 4 2 8
    Age Categorical
    Units: Participants
        <=18 years
    		 0 0 0 0
        Between 18 and 65 years
    		 2 4 2 8
        >=65 years
    		 0 0 0 0
    Sex: Female, Male
    Units: Subjects
        Female
    		 2 4 2 8
        Male
    		 0 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 0 0 0 0
        White
    		 2 4 2 8
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 1 0 1
        Not Hispanic or Latino
    		 2 3 2 7
        Unknown or Not Reported
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Vilaprisan (BAY1002670) 2 mg
    Reporting group description
    		 Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 2 mg.

    Reporting group title
    Vilaprisan (BAY1002670) 4 mg
    Reporting group description
    		 Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 4 mg

    Reporting group title
    Placebo
    Reporting group description
    		 Premenopausal women 18 years and older with endometriosis received placebo.

    Primary: Mean worst pelvic pain (measured on a numerical rating scale [NRS], recorded in the daily endometriosis symptom diary [ESD])

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    End point title
    		 Mean worst pelvic pain (measured on a numerical rating scale [NRS], recorded in the daily endometriosis symptom diary [ESD]) [1]
    End point description
    Pain intensity was assessed on 11-point (0-10) NRS by ESD item 1. In ESD item 1, participants were asked to rate the worst pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. Mean ‘worst pelvic pain’ was calculated as the sum of the participant’s daily assessments of the ESD item 1 (“worst pain” during the last 24 hours) during a study period divided by number of days with pain assessment in that study period. This was summarized by study period. No inferential statistical analysis was performed.
    End point type
    Primary
    End point timeframe
    Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days)
    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: No inferential statistical analysis was performed due to a small population.
    End point values
    		 Vilaprisan (BAY1002670) 2 mg Vilaprisan (BAY1002670) 4 mg Placebo
    Number of subjects analysed
    2
    4
    2
    Units: Scores on a scale
    arithmetic mean (full range (min-max))
        Screening period
    6.0 (5.3 to 6.8)
    5.8 (4.0 to 7.1)
    5.6 (5.5 to 5.7)
        Treatment period
    3.0 (2.0 to 4.0)
    3.8 (1.9 to 5.6)
    5.0 (4.1 to 5.9)
    No statistical analyses for this end point

    Secondary: Mean worst pelvic pain (measured on a numerical rating scale [NRS], recorded in the daily endometriosis symptom diary [ESD]) on days with/without vaginal bleeding

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    End point title
    		 Mean worst pelvic pain (measured on a numerical rating scale [NRS], recorded in the daily endometriosis symptom diary [ESD]) on days with/without vaginal bleeding
    End point description
    Pain intensity was assessed on 11-point (0-10) NRS by ESD item 1. In ESD item 1, participants were asked to rate the worst pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. Mean ‘worst pelvic pain’ on bleeding/non-bleeding days was calculated as the sum of the participant’s daily assessments of the ESD item 1 (“worst pain” during the last 24 hours) on bleedings/non-bleeding days during a study period divided by number of bleeding/non-bleeding days with pain assessment in that study period. This was summarized by study period. No inferential statistical analysis was performed. "99999" in below table stands for no data available as no subject had pain on vaginal bleeding days in the treatment period.
    End point type
    Secondary
    End point timeframe
    Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days)
    End point values
    		 Vilaprisan (BAY1002670) 2 mg Vilaprisan (BAY1002670) 4 mg Placebo
    Number of subjects analysed
    2
    4
    2
    Units: Scores on a scale
    arithmetic mean (full range (min-max))
        Screening: Worst Pain with vaginal bleeding
    6.5 (4.6 to 8.4)
    6.9 (4.9 to 8.4)
    7.0 (6.9 to 7.0)
        Screening: Worst Pain without vaginal bleeding
    5.9 (5.5 to 6.3)
    5.5 (3.7 to 6.7)
    5.3 (5.1 to 5.6)
        Treatment: Worst Pain with vaginal bleeding
    99999 (99999 to 99999)
    5.4 (3.8 to 7.0)
    6.0 (5.1 to 6.9)
        Treatment: Worst Pain without vaginal bleeding
    3.0 (2.0 to 4.0)
    3.7 (1.8 to 5.6)
    4.7 (4.0 to 5.5)
    No statistical analyses for this end point

    Secondary: Mean number of tablets of rescue pain medication 1 (Ibuprofen 200 mg) taken daily for Endometriosis-associated pelvic pain (EAPP)

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    End point title
    		 Mean number of tablets of rescue pain medication 1 (Ibuprofen 200 mg) taken daily for Endometriosis-associated pelvic pain (EAPP)
    End point description
    Mean number of tablets of rescue pain medication 1 (Ibuprofen 200 mg) taken daily for EAPP was calculated as the sum of the tablets taken for EAPP during a study period divided by the number of days in that study period. This was summarized by study period. No inferential statistical analysis was performed.
    End point type
    Secondary
    End point timeframe
    Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days)
    End point values
    		 Vilaprisan (BAY1002670) 2 mg Vilaprisan (BAY1002670) 4 mg Placebo
    Number of subjects analysed
    2
    4
    2
    Units: Tablets
    arithmetic mean (full range (min-max))
        Screening period
    0.61 (0.35 to 0.86)
    1.01 (0 to 2.14)
    1.03 (0.31 to 1.74)
        Treatment period
    0.09 (0.01 to 0.17)
    0.16 (0.05 to 0.42)
    0.81 (0.33 to 1.30)
    No statistical analyses for this end point

    Secondary: Mean number of tablets of rescue pain medication 2 (Tramadol 50 mg) taken daily for Endometriosis-associated pelvic pain (EAPP)

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    End point title
    		 Mean number of tablets of rescue pain medication 2 (Tramadol 50 mg) taken daily for Endometriosis-associated pelvic pain (EAPP)
    End point description
    Mean number of tablets of rescue pain medication 2 (Tramadol 50 mg) taken daily for EAPP was calculated as the sum of the tablets taken for EAPP during a study period divided by the number of days in that study period. This was summarized by study period. No inferential statistical analysis was performed.
    End point type
    Secondary
    End point timeframe
    Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days)
    End point values
    		 Vilaprisan (BAY1002670) 2 mg Vilaprisan (BAY1002670) 4 mg Placebo
    Number of subjects analysed
    2
    4
    2
    Units: Tablets
    arithmetic mean (full range (min-max))
        Screening period
    0 (0 to 0)
    0 (0 to 0)
    0.17 (0 to 0.34)
        Treatment period
    0.01 (0 to 0.03)
    0.01 (0 to 0.05)
    0.02 (0.01 to 0.02)
    No statistical analyses for this end point

    Secondary: The number of participants with treatment emergent adverse events (TEAEs)

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    End point title
    		 The number of participants with treatment emergent adverse events (TEAEs)
    End point description
    An adverse event (AE) is any untoward medical occurrence (i.e. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a patient or clinical investigation subject after providing written informed consent for participation in the study. TEAE is defined as AE that is observed or reported after the first administration of study drug or if it starts before the first administration of study drug and the intensity/grade worsens on treatment) in this study.
    End point type
    Secondary
    End point timeframe
    Up to 6 months
    End point values
    		 Vilaprisan (BAY1002670) 2 mg Vilaprisan (BAY1002670) 4 mg Placebo
    Number of subjects analysed
    2
    4
    2
    Units: Participants
        Non-serious TEAEs
    2
    3
    2
        SAEs
    1
    3
    0
        Deaths
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with clinical significant abnormal endometrial histology findings

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    End point title
    		 Number of participants with clinical significant abnormal endometrial histology findings
    End point description
    Number of participants with endometrial histology findings, e.g. hyperplasia, malignant neoplasm or endometrial polyps
    End point type
    Secondary
    End point timeframe
    Up to 6 months
    End point values
    		 Vilaprisan (BAY1002670) 2 mg Vilaprisan (BAY1002670) 4 mg Placebo
    Number of subjects analysed
    2
    4
    2
    Units: Participants
        Endometrial hyperplasia
    0
    0
    0
        Malignant neoplasm
    0
    0
    0
        Endometrial polyps
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with clinical significant abnormal ultrasound examinations

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    End point title
    		 Number of participants with clinical significant abnormal ultrasound examinations
    End point description
    Ultrasound examinations (evaluated for efficacy and safety) will be performed by a qualified expert in performing gynecologic ultrasound exams. If possible, the same examiner should conduct all examinations of a subject throughout the study and the same ultrasound machine (per site) should be used throughout the study. Preferably the safety evaluation should be performed by transvaginal ultrasound (TVU). However, if deemed appropriate, transabdominal or transrectal ultrasound examinations can be performed instead. The chosen method should be used consistently throughout the study.
    End point type
    Secondary
    End point timeframe
    Up to 6 months
    End point values
    		 Vilaprisan (BAY1002670) 2 mg Vilaprisan (BAY1002670) 4 mg Placebo
    Number of subjects analysed
    2
    4
    2
    Units: Participants
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with clinical significant abnormal bone mineral density measurements

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    End point title
    		 Number of participants with clinical significant abnormal bone mineral density measurements
    End point description
    A Dual-energy X-ray absorptiometry (DEXA) scan of the lumbar spine (lumbar anterior-posterior, L1-L4) and the hip/femoral neck were performed.
    End point type
    Secondary
    End point timeframe
    Up to 6 months
    End point values
    		 Vilaprisan (BAY1002670) 2 mg Vilaprisan (BAY1002670) 4 mg Placebo
    Number of subjects analysed
    2
    4
    2
    Units: Participants
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with clinical significant abnormal laboratory values

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    End point title
    		 Number of participants with clinical significant abnormal laboratory values
    End point description
    Clinical laboratory values including the values of hematology, general chemistry, urinalysis, coagulation, hormones, immunology and vitamins.
    End point type
    Secondary
    End point timeframe
    Up to 6 months
    End point values
    		 Vilaprisan (BAY1002670) 2 mg Vilaprisan (BAY1002670) 4 mg Placebo
    Number of subjects analysed
    2
    4
    2
    Units: Participants
    0
    3
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected from first study medication intake until last visit of the subject.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    Vilaprisan 2mg
    Reporting group description
    		 Vilaprisan 2mg

    Reporting group title
    Vilaprisan 4mg
    Reporting group description
    		 Vilaprisan 4mg

    Serious adverse events
    		 Placebo Vilaprisan 2mg Vilaprisan 4mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    3 / 4 (75.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adrenal adenoma
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Endometriosis ablation
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Endometriosis
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo Vilaprisan 2mg Vilaprisan 4mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 2 (100.00%)
    2 / 2 (100.00%)
    3 / 4 (75.00%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    2
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Reproductive system and breast disorders
    Vaginal discharge
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Vulvovaginal dryness
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Adenomyosis
         subjects affected / exposed
    2 / 2 (100.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Depressed mood
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Mood altered
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Adjustment disorder
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Investigations
    Cortisol increased
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Intraocular pressure increased
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Weight increased
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Bone density decreased
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 2 (100.00%)
    1 / 2 (50.00%)
    2 / 4 (50.00%)
         occurrences all number
    20
    6
    27
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Nausea
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    0
    1
    Toothache
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    3
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    2 / 4 (50.00%)
         occurrences all number
    0
    0
    2
    Hyperhidrosis
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    2
    Bone pain
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Fungal skin infection
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Gingivitis
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Influenza
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    2
    Nasopharyngitis
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    3
    1
    Pyelitis
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Tonsillitis
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Vaginal infection
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Iron deficiency
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    2 / 4 (50.00%)
         occurrences all number
    0
    0
    2

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Mar 2018
    Protocol amendment 2 is based on HA’s request on more robust liver safety data because of a possible liver safety signal observed with another drug in the same product group of selective progesterone receptor modulators (PRMs) as vilaprisan. The section on Adverse Events of Special Interest was updated, putting emphasis on patients proactively reporting symptoms that they perceive as unusual or of concern will result in medically meaningful interactions with the investigators.
    26 Jun 2018
    Protocol amendment 3: The purpose of this amendment is to address specific recommendations from a Health Authority for liver safety monitoring due the potential risk of liver injury observed with another drug in the same product group of selective progesterone receptor modulators (PRMs) as vilaprisan.
    11 Dec 2018
    Protocol amendment 6 triggered by Health Authority feedback based on preliminary findings from 2-year animal carcinogenicity studies (rat/mouse) with vilaprisan that were received in 2018 showed evidence of an increased incidence in endometrial and adrenal neoplasms. While these unexpected findings and their relevance for humans were further evaluated, Bayer decided to temporarily pause enrollment and randomization, and to temporarily stop study treatment in already randomized patients after completion of the ongoing treatment period. This global protocol amendment provided background, justification, as well as a detailed description of the temporary measures to be taken.
    19 Nov 2019
    Protocol amendment 7: Bayer had decided to close all clinical studies with vilaprisan. Although the outcome of the investigations regrading pre-clinical toxicology findings and their relevance to humans revealed to be of limited relevance to the human situation, Bayer decided to conduct a comprehensive safety follow up to provide additional confirmatory evidence. This amendment introduced measures and processes to prepare this study for an orderly closure, including safety follow up measures in all study participants who received at least one dose of study drug vilaprisan.
    28 Nov 2019
    Protocol amendment 8 added a clarification present in the other study protocols of the vilaprisan development project uterine fibroids, i.e. that in subjects who discontinued the study during the temporary pause and now get reconsented, conditions that newly occurred or worsened during the off-study period should be documented as AEs.
    17 Feb 2020
    Protocol amendment 9 Recently Bayer received comments from HA feedback regarding details of the safety follow-up measures introduced in the protocol amendments 7 and 8. This amendment implements these HA recommendations on eg. counselling about medical follow up.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    11 Dec 2018
    Bayer decided to temporarily pause enrollment and randomization, and to temporarily stop study treatment in already randomized patients after completion of the ongoing treatment period.
    19 Nov 2019

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    No inferential statistical analysis was performed due to a small population.
    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.

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