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    Clinical Trial Results:
    A randomised, double-blind, placebo-controlled, proof-of-mechanism phase 2 trial investigating the effect of quinagolide extended-release vaginal ring on reduction of lesions assessed by high-resolution magnetic resonance imaging in women with endometrioma, deep infiltrating endometriosis, and/or adenomyosis

    Summary
    EudraCT number
    		 2018-000915-26
    Trial protocol
    		 DE   DK   IT  
    Global end of trial date
    18 Jul 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jul 2022
    First version publication date
    07 Jul 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    000295
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03749109
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ferring Pharmaceuticals A/S
    Sponsor organisation address
    International PharmaScience Center, Amager Strandvej 405, Kastrup, Denmark, 2770
    Public contact
    Global Clinical Compliance, Ferring Pharmaceuticals A/S, DK0-Disclosure@ferring.com
    Scientific contact
    Global Clinical Compliance, Ferring Pharmaceuticals A/S, DK0-Disclosure@ferring.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 Aug 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Jun 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jul 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effect of quinagolide vaginal ring compared to placebo on reduction of lesions for endometrioma, deep infiltrating endometriosis (DIE) and adenomyosis assessed by high-resolution magnetic resonance imaging (MRI)
    Protection of trial subjects
    The trial was performed in compliance with International Council for Harmonisation (ICH) guideline on Good Clinical Practice (GCP)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 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
    Denmark: 3
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Poland: 60
    Worldwide total number of subjects
    67
    EEA total number of subjects
    67
    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)
    67
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was performed in 6 investigational sites in 3 countries between Aug 2019 to Jul 2021.

    Pre-assignment
    Screening details
    		 In total, 147 subjects were screened. Of these, 80 were screening failures and 67 were randomized and exposed to the investigational medicinal product (IMP): 35 to Quinagolide and 32 to Placebo.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Quinagolide 1080 µg
    Arm description
    		 Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg. Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases
    Arm type
    		 Experimental

    Investigational medicinal product name
    Quinagolide 1080 µg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Vaginal delivery system
    Routes of administration
    Vaginal use
    Dosage and administration details
    Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.

    Arm title
    		 Placebo
    Arm description
    		 Vaginal ring containing matching placebo Placebo: Matching placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Vaginal delivery system
    Routes of administration
    Vaginal use
    Dosage and administration details
    Vaginal ring containing matching placebo

    Number of subjects in period 1
    		Quinagolide 1080 µg Placebo
    Started
    35
    32
    Completed
    33
    32
    Not completed
    2
    0
         Adverse event, non-fatal
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Quinagolide 1080 µg
    Reporting group description
    		 Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg. Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases

    Reporting group title
    Placebo
    Reporting group description
    		 Vaginal ring containing matching placebo Placebo: Matching placebo

    Reporting group values
    		 Quinagolide 1080 µg Placebo Total
    Number of subjects
    		 35 32 67
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 35 32 67
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36.9 ( 5.51 ) 35.2 ( 5.96 ) -
    Gender categorical
    Units: Subjects
        Female
    		 35 32 67
        Male
    		 0 0 0
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 35 32 67
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 1 0 1
        White
    		 34 32 66
    Body Mass Index (BMI)
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 23.91 ( 3.86 ) 23.30 ( 4.15 ) -
    Subject analysis sets

    Subject analysis set title
    Full analysis set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified. The FAS comprised all randomised and exposed subjects according to the planned treatment; this included 35 subjects in the quinagolide vaginal ring group and 32 subjects in the placebo vaginal ring group. The FAS by each lesion type is primarily used for presenting the efficacy results.

    Subject analysis sets values
    		 Full analysis set (FAS)
    Number of subjects
    67
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    36.1 ( 5.75 )
    Gender categorical
    Units: Subjects
        Female
        Male
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    Race
    Units: Subjects
        American Indian or Alaska Native
        White
    Body Mass Index (BMI)
    Units: kg/m^2
        arithmetic mean (standard deviation)
    23.62 ( 3.98 )

    End points

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    End points reporting groups
    Reporting group title
    Quinagolide 1080 µg
    Reporting group description
    		 Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg. Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases

    Reporting group title
    Placebo
    Reporting group description
    		 Vaginal ring containing matching placebo Placebo: Matching placebo

    Subject analysis set title
    Full analysis set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified. The FAS comprised all randomised and exposed subjects according to the planned treatment; this included 35 subjects in the quinagolide vaginal ring group and 32 subjects in the placebo vaginal ring group. The FAS by each lesion type is primarily used for presenting the efficacy results.

    Primary: Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4

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    End point title
    		 Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4
    End point description
    The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. At screening, every measurable lesion (defined as ≥10 mm in size) of any type was recorded and was summed up by type for primary analysis.
    End point type
    Primary
    End point timeframe
    At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) Quinagolide 1080 µg: Endometrioma (n=25), DIE (n=19), Adenomyosis (n=20) Placebo: Endometrioma (n=22), DIE (n=26), Adenomyosis (n=16)
    End point values
    		 Quinagolide 1080 µg Placebo
    Number of subjects analysed
    35
    32
    Units: mm
    least squares mean (standard error)
        Endometrioma
    -0.20 ( 4.34 )
    -1.94 ( 4.48 )
        DIE
    2.41 ( 2.52 )
    -0.94 ( 2.03 )
        Adenomyosis
    -3.10 ( 3.75 )
    -3.43 ( 3.87 )
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    Endometrioma
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.78
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    1.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.45
         upper limit
    		 13.94
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    DIE
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.29
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    3.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.89
         upper limit
    		 9.59
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    Adenomyosis
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.95
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.33
         upper limit
    		 10.99
    Variability estimate
    Standard error of the mean

    Secondary: Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4

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    End point title
    		 Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4
    End point description
    The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
    End point type
    Secondary
    End point timeframe
    At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) Quinagolide 1080 µg: Endometrioma (n=22), DIE (n=17), Adenomyosis (n=17) Placebo: Endometrioma (n=21), DIE (n=25), Adenomyosis (n=16)
    End point values
    		 Quinagolide 1080 µg Placebo
    Number of subjects analysed
    35
    32
    Units: Percentage of changes in the size
    arithmetic mean (standard deviation)
        Endometrioma
    15.64 ( 70.12 )
    -6.83 ( 44.46 )
        DIE
    7.67 ( 15.22 )
    5.81 ( 37.73 )
        Adenomyosis
    -3.04 ( 32.31 )
    -6.99 ( 25.48 )
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    Endometrioma
    Comparison groups
    Placebo v Quinagolide 1080 µg
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.65
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    -6.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -36.8
         upper limit
    		 22.82
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    DIE
    Comparison groups
    Placebo v Quinagolide 1080 µg
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.92
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    -1.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.77
         upper limit
    		 20.51
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    Adenomyosis
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.74
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    -5.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -40.94
         upper limit
    		 29.1
    Variability estimate
    Standard error of the mean

    Secondary: Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4

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    End point title
    		 Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4
    End point description
    The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
    End point type
    Secondary
    End point timeframe
    At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) Quinagolide 1080 µg: Endometrioma (n=53), DIE (n=26), Adenomyosis (n=33) Placebo: Endometrioma (n=46), DIE (n=33), Adenomyosis (n=29)
    End point values
    		 Quinagolide 1080 µg Placebo
    Number of subjects analysed
    35
    32
    Units: Percentage of lesions
    number (not applicable)
        Endometrioma
    18.9
    21.7
        DIE
    0
    12.1
        Adenomyosis
    12.1
    24.1
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    Endometrioma
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.95
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.38
         upper limit
    		 2.82
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    Adenomyosis
    Comparison groups
    Placebo v Quinagolide 1080 µg
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.39
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.14
         upper limit
    		 2.17

    Secondary: Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4

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    End point title
    		 Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4
    End point description
    The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
    End point type
    Secondary
    End point timeframe
    At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) Quinagolide 1080 µg: Endometrioma (n=25), DIE (n=19), Adenomyosis (n=20) Placebo: Endometrioma (n=22), DIE (n=26), Adenomyosis (n=16)
    End point values
    		 Quinagolide 1080 µg Placebo
    Number of subjects analysed
    35
    32
    Units: Percentage of subjects
    number (not applicable)
        Endometrioma
    24.0
    31.8
        DIE
    0
    11.5
        Adenomyosis
    15.0
    37.5
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    Endometrioma
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.19
         upper limit
    		 2.65
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    Adenomyosis
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.21
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.07
         upper limit
    		 1.79

    Secondary: Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4

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    End point title
    		 Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4
    End point description
    The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
    End point type
    Secondary
    End point timeframe
    At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
    End point values
    		 Quinagolide 1080 µg Placebo
    Number of subjects analysed
    35
    32
    Units: Lesions
    number (not applicable)
        Endometrioma - Disappearing Lesions
    14
    5
        DIE - Disappearing Lesions
    0
    1
        Adenomyosis - Disappearing Lesions
    1
    2
        Endometrioma - New Lesions
    3
    3
        DIE - New Lesions
    0
    0
        Adenomyosis - New Lesions
    0
    0
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    Endometrioma - Disappearing Lesions
    Comparison groups
    Placebo v Quinagolide 1080 µg
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.13
    Method
    		 Negative-binomial regression
    Parameter type
    		 Rate Ratio
    Point estimate
    2.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 8.39
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.56
    Method
    		 Negative-binomial regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.04
         upper limit
    		 5.41

    Secondary: Changes in the Volumes (mm3) of Endometrioma and DIE Lesions Summed by Type on MR Images at Cycle 4

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    End point title
    		 Changes in the Volumes (mm3) of Endometrioma and DIE Lesions Summed by Type on MR Images at Cycle 4
    End point description
    The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
    End point type
    Secondary
    End point timeframe
    At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) Quinagolide 1080 µg: Endometrioma (n=25), DIE (n=19) Placebo: Endometrioma (n=22), DIE (n=26)
    End point values
    		 Quinagolide 1080 µg Placebo
    Number of subjects analysed
    35
    32
    Units: mm3
    least squares mean (standard error)
        Endometrioma
    2.12 ( 4.62 )
    1.89 ( 4.77 )
        DIE
    -0.15 ( 1.81 )
    -0.87 ( 1.25 )
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    Endometrioma
    Comparison groups
    Placebo v Quinagolide 1080 µg
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.97
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    0.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.78
         upper limit
    		 13.23
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    DIE
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.74
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.63
         upper limit
    		 5.07
    Variability estimate
    Standard error of the mean

    Secondary: Changes in the Sizes of Endometrioma Assessed by Transvaginal Ultrasound (TVU) at Cycle 4

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    End point title
    		 Changes in the Sizes of Endometrioma Assessed by Transvaginal Ultrasound (TVU) at Cycle 4
    End point description
    Transvaginal ultrasound (TVU) will be performed, preferably by the same sonographer, at the screening visit and at end-of-treatment / cycle 4.
    End point type
    Secondary
    End point timeframe
    At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
    End point values
    		 Quinagolide 1080 µg Placebo
    Number of subjects analysed
    18
    17
    Units: mm
    least squares mean (standard error)
        Endometrioma
    14.19 ( 8.70 )
    4.06 ( 9.02 )
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.42
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    10.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.74
         upper limit
    		 35
    Variability estimate
    Standard error of the mean

    Secondary: Changes in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&B) Scale at Cycle 4

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    End point title
    		 Changes in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&B) Scale at Cycle 4
    End point description
    B&B scale is a used scale for endometriosis that consists of two parts, with the first part evaluating symptoms (i.e. different types of pain) and the second part evaluating physical signs. B&B scale is a 4-point scale with 0=none and 3=severe.
    End point type
    Secondary
    End point timeframe
    At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) Quinagolide 1080 µg: Endometrioma (n=24), DIE (n=19), Adenomyosis (n=20) Placebo: Endometrioma (n=22), DIE (n=26), Adenomyosis (n=16)
    End point values
    		 Quinagolide 1080 µg Placebo
    Number of subjects analysed
    35
    32
    Units: Change of score of B&B scale
    least squares mean (standard deviation)
        Endometrioma
    -1.2 ( 2.26 )
    -2.1 ( 2.51 )
        DIE
    -1.3 ( 2.16 )
    -1.6 ( 2.21 )
        Adenomyosis
    -1.5 ( 2.33 )
    -1.9 ( 1.86 )
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    Endometrioma
    Comparison groups
    Placebo v Quinagolide 1080 µg
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 2.38
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    DIE
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.67
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    0.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.02
         upper limit
    		 1.58
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    Adenomyosis
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.64
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    0.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.06
         upper limit
    		 1.71

    Secondary: Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4

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    End point title
    		 Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4
    End point description
    Assessed by participants. NRS is a 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain Quinagolide 1080 µg: Endometrioma (n=24), DIE (n=19) Adenomyosis cycle 1 (n=20), cycle 2 (n=20), cycle 3 (n=19), cycle 4 (n=20) Placebo: Endometrioma (n=22), DIE (n=26), Adenomyosis (n=16)
    End point type
    Secondary
    End point timeframe
    At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
    End point values
    		 Quinagolide 1080 µg Placebo
    Number of subjects analysed
    35
    32
    Units: score on a scale
    least squares mean (standard deviation)
        Endometrioma at cycle 1
    -0.5 ( 1.96 )
    -0.7 ( 2.21 )
        Endometrioma at cycle 2
    -0.9 ( 2.17 )
    -1.1 ( 2.85 )
        Endometrioma at cycle 3
    -1.7 ( 2.73 )
    -1.1 ( 1.67 )
        Endometrioma at cycle 4
    -1.5 ( 3.11 )
    -2.0 ( 1.94 )
        DIE at cycle 1
    -0.6 ( 2.14 )
    -0.7 ( 2.19 )
        DIE at cycle 2
    -1.1 ( 2.20 )
    -1.4 ( 2.97 )
        DIE at cycle 3
    -1.7 ( 2.65 )
    -1.0 ( 1.97 )
        DIE at cycle 4
    -1.2 ( 2.27 )
    -2.1 ( 2.21 )
        Adenomyosis at cycle 1
    0.3 ( 1.84 )
    -0.7 ( 2.24 )
        Adenomyosis at cycle 2
    -0.7 ( 2.37 )
    -0.9 ( 2.13 )
        Adenomyosis at cycle 3
    -0.8 ( 2.34 )
    -0.9 ( 1.78 )
        Adenomyosis at cycle 4
    -1.6 ( 2.91 )
    -1.9 ( 2.28 )
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    Endometrioma at cycle 1
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.73
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    0.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.02
         upper limit
    		 1.44
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    Endometrioma at cycle 2
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.54
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    0.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.97
         upper limit
    		 1.82
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    Endometrioma at cycle 3
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.46
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.86
         upper limit
    		 0.85
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    Endometrioma at cycle 4
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.49
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    0.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.99
         upper limit
    		 2.05
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    DIE at cycle 1
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.99
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.32
         upper limit
    		 1.3
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    DIE at cycle 2
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.83
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.38
         upper limit
    		 1.71
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    DIE at cycle 3
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.28
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    -0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.11
         upper limit
    		 0.63
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    DIE at cycle 4
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.26
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.57
         upper limit
    		 2.07
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    Adenomyosis at cycle 1
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.19
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.49
         upper limit
    		 2.31
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    Adenomyosis at cycle 2
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.93
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.45
         upper limit
    		 1.58
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    Adenomyosis at cycle 3
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.85
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    -0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.58
         upper limit
    		 1.32
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    Adenomyosis at cycle 4
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.99
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.68
         upper limit
    		 1.69

    Secondary: Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4

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    End point title
    		 Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4
    End point description
    EHP-30 is a quality-of-life questionnaire. Score ranges from 0-100 and lower score denotes improvement. It consists of 30 questions measuring the frequency of the endometriosis impact on their quality of life during the past four weeks, with five options of never, rarely, sometimes, often and always.
    End point type
    Secondary
    End point timeframe
    At baseline, at menstrual cycles 2 (~2 months) and 4 (~4 months) Quinagolide 1080 µg: Endometrioma (n=24), DIE (n=19), Adenomyosis (n=20) Placebo: Endometrioma (n=22), DIE (n=26), Adenomyosis (n=16)
    End point values
    		 Quinagolide 1080 µg Placebo
    Number of subjects analysed
    35
    32
    Units: Score on a scale
    least squares mean (standard deviation)
        Endometrioma at cycle 2
    -46.6 ( 90.49 )
    -51.0 ( 71.60 )
        Endometrioma at cycle 4
    -56.6 ( 88.84 )
    -94.0 ( 85.14 )
        DIE at cycle 2
    -55.6 ( 91.14 )
    -41.7 ( 86.27 )
        DIE at cycle 4
    -54.8 ( 87.29 )
    -85.7 ( 98.96 )
        Adenomyosis at cycle 2
    -46.3 ( 102.92 )
    -33.2 ( 52.21 )
        Adenomyosis at cycle 4
    -64.9 ( 105.62 )
    -79.4 ( 90.04 )
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    Endometrioma at cycle 2
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.75
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    -7.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -53.97
         upper limit
    		 39.27
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    Endometrioma at cycle 4
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.42
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    17.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.41
         upper limit
    		 60.04
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    DIE at cycle 2
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.47
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    -17.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -66.3
         upper limit
    		 30.98
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    DIE at cycle 4
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.27
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    25.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.05
         upper limit
    		 72.27
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    Adenomyosis at cycle 2
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.41
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    -20.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -71.83
         upper limit
    		 29.92
    Statistical analysis title
    		 Quinagolide 1080 µg, Placebo
    Statistical analysis description
    Adenomyosis at cycle 4
    Comparison groups
    Quinagolide 1080 µg v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.93
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS mean
    Point estimate
    2.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -49.57
         upper limit
    		 54.06

    Secondary: Changes in the Menstrual Bleeding Pattern Over 4 Cycles

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    End point title
    		 Changes in the Menstrual Bleeding Pattern Over 4 Cycles
    End point description
    Assessed by patient self-reported answers to menstrual bleeding questions. The Menstrual Bleeding Pattern covered the Menstrual Cycle Duration and the Menstrual Bleeding Duration. Menstrual Cycle Duration: Quinagolide 1080 µg: Endometrioma cycle(C) 1 (n=23), C2 (n=24), C3 (n=22), C4 (n=23), DIE C1 (n=18), C2 (n=18), C3 (n=17), C4 (n=19), Adenomyosis C1 (n=19), C2 (n=19), C3 (n=16), C4 (n=18). Placebo: Endometrioma C1 (n=22), C2 (n=22), C3 (n=23), C4 (n=23), DIE C1 (n=26), C2 (n=26), C3 (n=27), C4 (n=26), Adenomyosis C1 (n=16), C2 (n=16), C3 (n=17), C4 (n=17). Menstrual Bleeding Duration: Quinagolide 1080 µg: Endometrioma C1 (n=24), C2 (n=25), C3 (n=24), C4 (n=26), DIE C1 (n=19), C2 (n=20), C3 (n=19), C4 (n=20), Adenomyosis C1 (n=19), C2 (n=19), C3 (n=16), C4 (n=18). Placebo: Endometrioma C1 (n=22), C2 (n=22), C3 (n=23), C4 (n=24), DIE C1 (n=26), C2 (n=26), C3 (n=27), C4 (n=27), Adenomyosis C1 (n=16), C2 (n=16), C3 (n=17), C4 (n=17).
    End point type
    Secondary
    End point timeframe
    At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
    End point values
    		 Quinagolide 1080 µg Placebo
    Number of subjects analysed
    35
    32
    Units: Days
    arithmetic mean (standard deviation)
        Endometrioma at baseline (cycle duration)
    31.9 ( 10.54 )
    32.6 ( 10.38 )
        Endometrioma at cycle 1 (cycle duration)
    27.8 ( 2.92 )
    26.9 ( 2.39 )
        Endometrioma at cycle 2 (cycle duration)
    28.1 ( 2.13 )
    27.4 ( 2.50 )
        Endometrioma at cycle 3 (cycle duration)
    27.7 ( 2.12 )
    28.3 ( 2.65 )
        Endometrioma at cycle 4 (cycle duration)
    28.2 ( 3.27 )
    26.9 ( 2.23 )
        DIE at baseline (cycle duration)
    33.2 ( 11.80 )
    31.4 ( 9.45 )
        DIE at cycle 1 (cycle duration)
    26.7 ( 2.66 )
    27.3 ( 2.78 )
        DIE at cycle 2 (cycle duration)
    27.4 ( 1.98 )
    27.7 ( 2.52 )
        DIE at cycle 3 (cycle duration)
    28.2 ( 2.86 )
    28.5 ( 2.29 )
        DIE at cycle 4 (cycle duration)
    26.9 ( 2.23 )
    27.7 ( 2.59 )
        Adenomyosis at baseline (cycle duration)
    33.5 ( 11.16 )
    32.4 ( 11.49 )
        Adenomyosis at cycle 1 (cycle duration)
    27.7 ( 2.54 )
    26.8 ( 2.61 )
        Adenomyosis at cycle 2 (cycle duration)
    28.3 ( 2.23 )
    27.4 ( 2.37 )
        Adenomyosis at cycle 3 (cycle duration)
    27.8 ( 2.52 )
    27.9 ( 1.93 )
        Adenomyosis at cycle 4 (cycle duration)
    27.2 ( 1.50 )
    27.4 ( 1.87 )
        Endometrioma at baseline (bleeding duration)
    5.1 ( 1.08 )
    5.1 ( 0.97 )
        Endometrioma at cycle 1 (bleeding duration)
    5.3 ( 1.71 )
    4.7 ( 0.77 )
        Endometrioma at cycle 2 (bleeding duration)
    5.3 ( 1.22 )
    5.1 ( 0.87 )
        Endometrioma at cycle 3 (bleeding duration)
    4.5 ( 1.61 )
    4.8 ( 0.89 )
        Endometrioma at cycle 4 (bleeding duration)
    5.0 ( 1.43 )
    4.7 ( 1.52 )
        DIE at baseline (bleeding duration)
    4.9 ( 0.99 )
    5.3 ( 1.01 )
        DIE at cycle 1 (bleeding duration)
    5.0 ( 1.60 )
    4.6 ( 0.70 )
        DIE at cycle 2 (bleeding duration)
    5.0 ( 1.82 )
    5.0 ( 1.04 )
        DIE at cycle 3 (bleeding duration)
    4.5 ( 1.22 )
    4.9 ( 0.93 )
        DIE at cycle 4 (bleeding duration)
    5.2 ( 1.04 )
    4.9 ( 1.60 )
        Adenomyosis at baseline (bleeding duration)
    5.2 ( 1.20 )
    5.4 ( 1.15 )
        Adenomyosis at cycle 1 (bleeding duration)
    5.0 ( 1.75 )
    4.9 ( 0.62 )
        Adenomyosis at cycle 2 (bleeding duration)
    4.6 ( 1.78 )
    4.8 ( 1.17 )
        Adenomyosis at cycle 3 (bleeding duration)
    4.3 ( 1.66 )
    4.7 ( 1.05 )
        Adenomyosis at cycle 4 (bleeding duration)
    5.0 ( 0.74 )
    5.0 ( 1.32 )
    No statistical analyses for this end point

    Secondary: Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4

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    End point title
    		 Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4
    End point description
    Assessed by blood sample collection Quinagolide 1080 µg: Endometrioma at cycle 1 (n=24), Endometrioma at cycle 2 (n=24), Endometrioma at cycle 4 (n=25), DIE at cycle 1 (n=19), DIE at cycle 2 (n=19), DIE at cycle 4 (n=19), Adenomyosis at cycle 1 (n=20), Adenomyosis at cycle 2 (n=20), Adenomyosis at cycle 4 (n=20). Placebo: Endometrioma at cycle 1 (n=21), Endometrioma at cycle 2 (n=22), Endometrioma at cycle 4 (n=22), DIE at cycle 1 (n=25), DIE at cycle 2 (n=26), DIE at cycle 4 (n=26), Adenomyosis at cycle 1 (n=15), Adenomyosis at cycle 2 (n=16), Adenomyosis at cycle 4 (n=16)
    End point type
    Secondary
    End point timeframe
    Within 1-5 days post randomisation, and at menstrual cycles 2 (~2 months) and 4 (~4 months)
    End point values
    		 Quinagolide 1080 µg Placebo
    Number of subjects analysed
    35
    32
    Units: pg/L
    least squares mean (standard deviation)
        Endometrioma at cycle 1
    5.51 ( 3.604 )
    12.68 ( 4.618 )
        Endometrioma at cycle 2
    9.30 ( 4.739 )
    12.79 ( 4.381 )
        Endometrioma at cycle 4
    9.47 ( 4.081 )
    12.31 ( 6.648 )
        DIE at cycle 1
    5.95 ( 3.258 )
    10.80 ( 4.201 )
        DIE at cycle 2
    10.36 ( 5.118 )
    11.85 ( 5.029 )
        DIE at cycle 4
    10.65 ( 4.465 )
    12.08 ( 6.739 )
        Adenomyosis at cycle 1
    5.80 ( 4.017 )
    12.13 ( 4.563 )
        Adenomyosis at cycle 2
    7.97 ( 2.608 )
    11.94 ( 4.150 )
        Adenomyosis at cycle 4
    9.35 ( 3.418 )
    11.95 ( 4.395 )
    No statistical analyses for this end point

    Secondary: Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4

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    End point title
    		 Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4
    End point description
    Assessed by blood sample collection Quinagolide 1080 µg: Endometrioma at cycle 1 (n=24), Endometrioma at cycle 2 (n=24), Endometrioma at cycle 4 (n=25), DIE at cycle 1 (n=19), DIE at cycle 2 (n=19), DIE at cycle 4 (n=19), Adenomyosis at cycle 1 (n=20), Adenomyosis at cycle 2 (n=20), Adenomyosis at cycle 4 (n=20). Placebo: Endometrioma at cycle 1 (n=21), Endometrioma at cycle 2 (n=22), Endometrioma at cycle 4 (n=22), DIE at cycle 1 (n=25), DIE at cycle 2 (n=26), DIE at cycle 4 (n=26), Adenomyosis at cycle 1 (n=15), Adenomyosis at cycle 2 (n=16), Adenomyosis at cycle 4 (n=16)
    End point type
    Secondary
    End point timeframe
    Within 1-5 days post randomisation, and at menstrual cycles 2 (~2 months) and 4 (~4 months)
    End point values
    		 Quinagolide 1080 µg Placebo
    Number of subjects analysed
    35
    32
    Units: mIU/L
    arithmetic mean (standard deviation)
        Endometrioma at cycle 1
    1.672 ( 1.3376 )
    1.513 ( 0.6822 )
        Endometrioma at cycle 2
    1.785 ( 1.0535 )
    1.509 ( 0.6746 )
        Endometrioma at cycle 4
    1.692 ( 0.9489 )
    1.422 ( 0.6528 )
        DIE at cycle 1
    1.706 ( 1.5550 )
    1.394 ( 0.8200 )
        DIE at cycle 2
    1.726 ( 1.1633 )
    1.383 ( 0.6903 )
        DIE at cycle 4
    1.375 ( 0.8953 )
    1.299 ( 0.6571 )
        Adenomyosis at cycle 1
    2.067 ( 1.8100 )
    1.325 ( 0.7248 )
        Adenomyosis at cycle 2
    1.722 ( 1.1557 )
    1.311 ( 0.5664 )
        Adenomyosis at cycle 4
    1.801 ( 0.9463 )
    1.353 ( 0.5614 )
    No statistical analyses for this end point

    Secondary: Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4

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    End point title
    		 Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4
    End point description
    Assessed by blood sample collection Quinagolide 1080 µg: Endometrioma at cycle 1 (n=24), Endometrioma at cycle 2 (n=23), Endometrioma at cycle 4 (n=25), DIE at cycle 1 (n=19), DIE at cycle 2 (n=19), DIE at cycle 4 (n=19), Adenomyosis at cycle 1 (n=20), Adenomyosis at cycle 2 (n=19), Adenomyosis at cycle 4 (n=20). Placebo: Endometrioma at cycle 1 (n=21), Endometrioma at cycle 2 (n=22), Endometrioma at cycle 4 (n=22), DIE at cycle 1 (n=25), DIE at cycle 2 (n=26), DIE at cycle 4 (n=26), Adenomyosis at cycle 1 (n=15), Adenomyosis at cycle 2 (n=16), Adenomyosis at cycle 4 (n=16)
    End point type
    Secondary
    End point timeframe
    Within 1-5 days post randomisation, and at menstrual cycles 2 (~2 months) and 4 (~4 months)
    End point values
    		 Quinagolide 1080 µg Placebo
    Number of subjects analysed
    35
    32
    Units: nmol/L
    arithmetic mean (standard deviation)
        Endometrioma at cycle 1
    23.90 ( 8.002 )
    22.96 ( 6.721 )
        Endometrioma at cycle 2
    19.9 ( 6.511 )
    21.81 ( 5.481 )
        Endometrioma at cycle 4
    21.82 ( 5.450 )
    20.22 ( 5.786 )
        DIE at cycle 1
    22.16 ( 8.099 )
    23.68 ( 6.135 )
        DIE at cycle 2
    18.01 ( 5.484 )
    21.07 ( 6.526 )
        DIE at cycle 4
    20.98 ( 5.678 )
    20.53 ( 6.083 )
        Adenomyosis at cycle 1
    21.80 ( 7.763 )
    22.51 ( 4.580 )
        Adenomyosis at cycle 2
    19.17 ( 6.497 )
    19.93 ( 5.233 )
        Adenomyosis at cycle 4
    21.19 ( 6.331 )
    18.93 ( 4.836 )
    No statistical analyses for this end point

    Secondary: Plasma Concentrations of Quinagolide and Its Metabolites During Cycles 1 to 4

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    End point title
    		 Plasma Concentrations of Quinagolide and Its Metabolites During Cycles 1 to 4 [1]
    End point description
    Assessed by blood sample collection. Quinagolide 1080 μg: Within 1-5 days of randomisation (n=30), Within 7-14 days of randomisation (n=32), Cycle 1 (n=32), Cycle 2 (n=33), Cycle 3 (n=32), Cycle 4 (n=32)
    End point type
    Secondary
    End point timeframe
    Within 1-5 days post randomisation, within 7-14 days post randomisation, and at menstrual cycles 1 (~1 months), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint measured the plasma concentration of Quinagolide and its metabolites. You cannot measure the plasma concentration of quinagolide for the subjects who have received placebo.
    End point values
    		 Quinagolide 1080 µg
    Number of subjects analysed
    33
    Units: pg/mL
    arithmetic mean (standard deviation)
        Within 1-5 days of randomisation
    11.66 ( 5.23 )
        Within 7-14 days of randomisation
    5.50 ( 2.59 )
        Cycle 1
    2.90 ( 1.33 )
        Cycle 2
    2.92 ( 1.68 )
        Cycle 3
    2.78 ( 1.32 )
        Cycle 4
    3.16 ( 3.03 )
    No statistical analyses for this end point

    Secondary: Changes in Clinical Chemistry and Hematology Parameters

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    End point title
    		 Changes in Clinical Chemistry and Hematology Parameters
    End point description
    Assessed by blood sample collection The parameters have different units. Hematocrit: % v/v Hemaglobin: g/L Ery. Mean Corpuscular Hemoglobin: pg/cell Ery. Mean Corpuscular HGB Concentration: g/L Ery. Mean Corpuscular Volume: fL Platelets: 10^9/L Erythrocytes: 10^12/L Leukocytes: 10^9/L Alanine Aminotransferase: U/L Albumin: g/L Alkaline Phosphatase: IU/L Aspartate Aminotransferase: U/L Bicarbonate: mmol/L Direct Bilirubin: umol/L Bilirubin: umol/L Calcium: mmol/L Chloride: mmol/L Cholesterol: mmol/L Creatinine: umol/L Gamma Glutamyl Transferase: U/L Glucose: mmol/L Lactate Dehydrogenase: U/L Phosphate: mmol/L Potassium: mmol/L Sodium: mmol/L Protein: g/L Urate: umol/L Urea Nitrogen: mmol/L
    End point type
    Secondary
    End point timeframe
    At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
    End point values
    		 Quinagolide 1080 µg Placebo
    Number of subjects analysed
    35
    32
    Units: % v/v
    arithmetic mean (standard deviation)
        Hematocrit
    -0.007 ( 0.0181 )
    -0.005 ( 0.0259 )
        Hemaglobin
    -3.6 ( 5.60 )
    -3.2 ( 8.69 )
        Ery. mean Corpuscular Hemoglobin
    -0.7 ( 0.71 )
    -0.6 ( 1.22 )
        Ery. Mean Corpuscular HGB Concentration
    -3.1 ( 7.11 )
    -4.3 ( 8.76 )
        Ery. Mean Corpuscular Volume
    -1.2 ( 2.11 )
    -0.7 ( 3.10 )
        Platelets
    4.9 ( 33.98 )
    11.6 ( 45.92 )
        Erythrocytes
    -0.02 ( 0.192 )
    -0.01 ( 0.228 )
        Leukocytes
    -0.43 ( 1.928 )
    0.18 ( 2.055 )
        Alanine Aminotransferase
    -1.1 ( 5.88 )
    -0.2 ( 3.86 )
        Albumin
    0.0 ( 2.28 )
    0.7 ( 2.84 )
        Alkaline Phosphatase
    3.1 ( 8.18 )
    4.2 ( 6.67 )
        Aspartate Aminotransferase
    1.0 ( 3.72 )
    0.5 ( 3.43 )
        Bicarbonate
    -2.7 ( 2.59 )
    -2.9 ( 2.51 )
        Direct Bilirubin
    0.0 ( 0.38 )
    0.0 ( 1.10 )
        Bilirubin
    -1.2 ( 2.84 )
    -0.8 ( 4.57 )
        Calcium
    0.009 ( 0.0896 )
    0.012 ( 0.0773 )
        Chloride
    0.2 ( 2.68 )
    -0.5 ( 2.49 )
        Cholesterol
    0.045 ( 0.5050 )
    0.244 ( 0.5219 )
        Creatinine
    -3.5 ( 8.21 )
    -4.3 ( 7.82 )
        Gamma Glutamyl Transferase
    -1.1 ( 4.77 )
    1.0 ( 4.46 )
        Glucose
    -0.07 ( 0.734 )
    -0.06 ( 0.866 )
        Lactate Dehydrogenase
    2.7 ( 12.30 )
    2.8 ( 8.42 )
        Phosphate
    -0.013 ( 0.1452 )
    0.048 ( 0.1885 )
        Potassium
    0.07 ( 0.333 )
    0.06 ( 0.357 )
        Sodium
    0.7 ( 2.04 )
    0.4 ( 2.54 )
        Protein
    -0.1 ( 3.82 )
    1.4 ( 3.19 )
        Urate
    10.7 ( 56.36 )
    1.3 ( 37.59 )
        Urea Nitrogen
    -0.180 ( 1.0184 )
    0.148 ( 1.2286 )
    No statistical analyses for this end point

    Secondary: Proportion of Subjects With Markedly Abnormal Changes in Clinical Chemistry and Hematology Parameters

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    End point title
    		 Proportion of Subjects With Markedly Abnormal Changes in Clinical Chemistry and Hematology Parameters
    End point description
    Assessed by blood sample collection
    End point type
    Secondary
    End point timeframe
    At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
    End point values
    		 Quinagolide 1080 µg Placebo
    Number of subjects analysed
    35
    32
    Units: Percentage of subjects
        number (not applicable)
    2.86
    0
    No statistical analyses for this end point

    Secondary: Frequency and Intensity of Adverse Events

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    End point title
    		 Frequency and Intensity of Adverse Events
    End point description
    Assessed by and Adverse Event Log completed by the Investigator
    End point type
    Secondary
    End point timeframe
    From obtaining the informed consent to end of trial (up to 6 menstrual cycles ~ around 6 months, each cycle is approximately 28 days)
    End point values
    		 Quinagolide 1080 µg Placebo
    Number of subjects analysed
    35
    32
    Units: Percentage of adverse events
    number (not applicable)
        Mild adverse events
    28.6
    43.8
        Moderate adverse events
    42.9
    37.5
        Severe adverse events
    2.9
    9.4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were recorded from the time of signed informed consent for participation in the trial to end-of-trial.
    Adverse event reporting additional description
    All adverse events with onset after start of first administration of IMP and before the follow-up phone call were considered treatment-emergent.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Quinagolide 1080 µg
    Reporting group description
    		 Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg. Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases

    Reporting group title
    Placebo
    Reporting group description
    		 Vaginal ring containing matching placebo Placebo: Matching placebo

    Serious adverse events
    		 Quinagolide 1080 µg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 32 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Quinagolide 1080 µg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 35 (57.14%)
    20 / 32 (62.50%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 35 (2.86%)
    4 / 32 (12.50%)
         occurrences all number
    1
    4
    Headache
         subjects affected / exposed
    6 / 35 (17.14%)
    8 / 32 (25.00%)
         occurrences all number
    9
    15
    Hypoaesthesia
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 32 (6.25%)
         occurrences all number
    0
    2
    Somnolence
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 32 (3.13%)
         occurrences all number
    4
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 35 (2.86%)
    2 / 32 (6.25%)
         occurrences all number
    1
    2
    Peripheral swelling
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 32 (3.13%)
         occurrences all number
    2
    1
    Pyrexia
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 32 (0.00%)
         occurrences all number
    5
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 32 (3.13%)
         occurrences all number
    2
    1
    Nausea
         subjects affected / exposed
    3 / 35 (8.57%)
    2 / 32 (6.25%)
         occurrences all number
    3
    3
    Rectal Haemorrhage
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 32 (6.25%)
         occurrences all number
    0
    4
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 32 (3.13%)
         occurrences all number
    2
    1
    Vulvovaginal pruritus
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Corona virus infection
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 32 (6.25%)
         occurrences all number
    0
    2
    Nasopharyngitis
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 32 (3.13%)
         occurrences all number
    2
    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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