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    Clinical Trial Results:
    Pharmacological treatment of hypersexual disorder; an open pilot study to evaluate the feasibility and effectiveness of treatment with Naltrexone

    Summary
    EudraCT number
    		 2018-001049-15
    Trial protocol
    		 SE  
    Global end of trial date
    29 Sep 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jun 2021
    First version publication date
    12 Jun 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HD-TREX
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ANOVA Karolinska University Hopsital
    Sponsor organisation address
    Norra Stationsgatan 69, Stockholm, Sweden,
    Public contact
    Josephine Savard, ANOVA (Andrologi, Sexualmedicin, Transmedicin), 46 851773200, josephine.savard@sll.se
    Scientific contact
    Josephine Savard, ANOVA (Andrologi, Sexualmedicin, Transmedicin), 46 851773200, josephine.savard@sll.se
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Apr 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Sep 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Sep 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this pilot study is to assess feasibility, efficacy and tolerability of Naltrexone treatment in patients with hypersexual disorder. The following research questions will be asked: 1. Is treatment with Naltrexone feasible for patients with Hypersexual disorder treated at a sub specialized unit? 2. Does Naltrexone reduce symptoms in patients with Hypersexual disorder? And if so, what clinical characteristics predict response? 3. What is the tolerability of Naltrexone in patients with Hypersexual disorder?
    Protection of trial subjects
    Blood chemistry and adverse event monitoring
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 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
    Sweden: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients seeking treatment due to troubled sexual behavior

    Pre-assignment
    Screening details
    		 37 men were screened, 20 were recrutied, 17 did not beet inclusion criteria mainly due to not meeting diagnose criteria

    Pre-assignment period milestones
    Number of subjects started
    		 20
    Number of subjects completed
    		 20

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 main arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    naltrexone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    25-50 mg daily use

    Number of subjects in period 1
    		main arm
    Started
    20
    Completed
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 20 20
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 20 20
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 20 20
    Subject analysis sets

    Subject analysis set title
    full anaysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    all subjects

    Subject analysis sets values
    		 full anaysis
    Number of subjects
    20
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    20
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    0
        Male
    20

    End points

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    End points reporting groups
    Reporting group title
    main arm
    Reporting group description
    		 -

    Subject analysis set title
    full anaysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    all subjects

    Primary: main end point

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    End point title
    		 main end point
    End point description
    End point type
    Primary
    End point timeframe
    after 4 weeks of treatment
    End point values
    		 main arm full anaysis
    Number of subjects analysed
    20
    20
    Units: 0-24 units
    1
    1
    Statistical analysis title
    		 paired sample t-test
    Statistical analysis description
    Longitudinal data of same group (n=20) at two time points
    Comparison groups
    main arm v full anaysis
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.9
         upper limit
    		 8
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    After 3-5 days with medication, weekly in the web-based plattform and at a consultation after 4 weeks. After 8 weeks (follow-up) adverse events were assessed. Bloodsamples were collected at baseline and after 4 weeks.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 PI designed
    Dictionary version
    1
    Reporting groups
    Reporting group title
    sponsor
    Reporting group description
    		 -

    Serious adverse events
    		 sponsor
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 sponsor
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 20 (95.00%)
    Nervous system disorders
    Fatigue
         subjects affected / exposed
    11 / 20 (55.00%)
         occurrences all number
    11
    Vertigo
         subjects affected / exposed
    6 / 20 (30.00%)
         occurrences all number
    6
    Apathy
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Headache
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Nightmare
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    6 / 20 (30.00%)
         occurrences all number
    6
    Abdominal pain
         subjects affected / exposed
    6 / 20 (30.00%)
         occurrences all number
    6
    Weight decreased
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Flatulence
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Sexual dysfunction
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Depressed mood
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32532705
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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