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    Clinical Trial Results:
    Gonadal dysfunction in male long-term survivors of malignant lymphoma

    Summary
    EudraCT number
    		 2020-002140-22
    Trial protocol
    		 DK  
    Global end of trial date
    10 Nov 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Jul 2023
    First version publication date
    22 Jul 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Vitality
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Copenhagen University hospital,Rigshospitalet
    Sponsor organisation address
    Blegdamsvej 9, kbh Ø, Denmark, 2100
    Public contact
    Department of hematology, Copenhagen University hospital,Rigshospitalet, +45 35453545, signe.micas.pedersen@regionh.dk
    Scientific contact
    Department of hematology, Copenhagen University hospital,Rigshospitalet, +45 35453545, signe.micas.pedersen@regionh.dk
    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
    06 Jul 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Nov 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Nov 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The approach to surveillance and treatment of gonadal dysfunction following remission with first line therapy for malignant lymphoma remains controversial. With a paucity of evidence whether follow-up programs and treatment are effective, evidence-based guidelines for follow-up and treatment of gonadal dysfunction are needed. The main purpose of the current study is to assess the extent of sexual dysfunction, quality of life (QoL) and reduced levels of testosterone in male patients with Hodgkin lymphoma (HL) and diffuse large B-cell lymphoma (DLBCL). Furthermore, in a prospective phase 2 study, to test the impact on QoL before and after substitution with testosterone in patients with reduced levels of testosterone.
    Protection of trial subjects
    Approval of the study was obtained from both the regional ethics commitee and the danish medicines agency. An independant monitor was involved during the study. All patients were screened for in- and exclusion criteria, making sure that no contraindications for treatment with the study drug was present.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 7
    Worldwide total number of subjects
    7
    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)
    7
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from a study screening for testosterone deficiency. Men treated for malignant lymphoma at least one year prior, were screened with measurements of serum total testosterone. If concentration were below age adjusted reference levels, they were informed about the current study and offered treatment for the deficiency.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 7
    Number of subjects completed
    		 7

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Overall study
    Arm description
    		 All patients were offered the same treatment with Testogel.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Testogel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous liquid
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Sachets of tesotserone gel was applied in the morning on arms og thighs. One sachet was initial dose, which could be increased to two sachets upon lack of efficacy.

    Number of subjects in period 1
    		Overall study
    Started
    7
    Control visit 1 month
    7
    Control visit 3 months
    7
    Control visit 6 months
    5
    Control visit 12 months
    4
    Completed
    4
    Not completed
    3
         Consent withdrawn by subject
    1
         Adverse event, non-fatal
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 -

    Reporting group values
    		 Overall study Total
    Number of subjects
    		 7 7
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 7 7
    Gender categorical
    all male participants
    Units: Subjects
        Female
    		 0 0
        Male
    		 7 7
    Subject analysis sets

    Subject analysis set title
    Vitality patients
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    7 patients with testosterone deficiency were included, to evaluate tolerance, hormonal response and sexual and general quality of life during one year of treatment with Testogel. 4 survivors completed the study with good results on both hormonal status, general quality of life and sexual health. All 4 were referred for further endocrinological treatment. One was stopped because of increased hemotacrit, one was stopped because of unrelated adverse event, and one wished to terminate treatment because of lack of effect. During the year of treatment, subjects were treated with daily Testogel, had blood samples drawn and filled in questionnaires at preplanned control visits.

    Subject analysis sets values
    		 Vitality patients
    Number of subjects
    7
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    7
    Age continuous
    Units:
        
    ±
    Gender categorical
    all male participants
    Units: Subjects
        Female
    0
        Male
    7

    End points

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    End points reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 All patients were offered the same treatment with Testogel.

    Subject analysis set title
    Vitality patients
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    7 patients with testosterone deficiency were included, to evaluate tolerance, hormonal response and sexual and general quality of life during one year of treatment with Testogel. 4 survivors completed the study with good results on both hormonal status, general quality of life and sexual health. All 4 were referred for further endocrinological treatment. One was stopped because of increased hemotacrit, one was stopped because of unrelated adverse event, and one wished to terminate treatment because of lack of effect. During the year of treatment, subjects were treated with daily Testogel, had blood samples drawn and filled in questionnaires at preplanned control visits.

    Primary: Effect of testosterone on QLQ C-30 score

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    End point title
    		 Effect of testosterone on QLQ C-30 score [1]
    End point description
    score change during treatment with testogel
    End point type
    Primary
    End point timeframe
    one year
    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: Because only 7 patients were enrolled in the study, statistical analyses is not possible.
    End point values
    		 Overall study Vitality patients
    Number of subjects analysed
    7
    7
    Units: questionnaire score
        number (not applicable)
    7
    7
    Attachments
    		 Treatment effect
    No statistical analyses for this end point

    Secondary: Effect of testosterone on QLQ SHQ-22 score

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    End point title
    		 Effect of testosterone on QLQ SHQ-22 score
    End point description
    Score change during treatment with Testogel
    End point type
    Secondary
    End point timeframe
    one year
    End point values
    		 Overall study Vitality patients
    Number of subjects analysed
    7
    7
    Units: Questionnaire score
        number (not applicable)
    7
    7
    Attachments
    		 Treatment effect
    No statistical analyses for this end point

    Secondary: Effect of testosterone on IIEF-5 score

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    End point title
    		 Effect of testosterone on IIEF-5 score
    End point description
    score change during treatment with Testogel
    End point type
    Secondary
    End point timeframe
    one year
    End point values
    		 Overall study Vitality patients
    Number of subjects analysed
    7
    7
    Units: questionnaire score
        number (not applicable)
    7
    7
    Attachments
    		 Treatment effect
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    one year
    Adverse event reporting additional description
    During the one year of treatment patients were controlled for adverse events in the study settings. After cessation of treatment, patients were controlled for events after one week. Patients continuing on Testogel after the end of study was follow-up by an endocrinologist.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTC
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 All patients were offered the same treatment with Testogel.

    Serious adverse events
    		 Overall study
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 4 (50.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Atrioventricular block complete
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Increased hemotocrit
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall study
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 4 (50.00%)
    General disorders and administration site conditions
    Nightsweats
    Additional description: Checked for malignancy without an concerns and continued on Testogel.
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 4 (50.00%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Mild rash
    Additional description: Unrelated to application site
         subjects affected / exposed
    1 / 4 (25.00%)
         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.
    Only 7 patients enrolled, why significant conclusions could not be made.
    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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