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    Clinical Trial Results:
    Pilot Study: Evaluating the effect of 300microgram testosterone patches in addition to Hormone Replacement Therapy on arterial compliance, insulin resistance and sexual desire

    Summary
    EudraCT number
    		 2009-013275-21
    Trial protocol
    		 GB  
    Global end of trial date
    07 Feb 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Dec 2019
    First version publication date
    18 Dec 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    05-2009
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01208038
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Imperial College London
    Sponsor organisation address
    South Kensington Campus, London, United Kingdom, SW7 2AZ
    Public contact
    Nick Panay, Imperial College London, +44 0208 383 1111, n.panay@imperial.ac.uk
    Scientific contact
    Nick Panay, Imperial College London, +44 0208 383 1111, n.panay@imperial.ac.uk
    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
    05 Feb 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Feb 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Feb 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The principle purpose of this study is to examine the effects of the testosterone patch, in conjuction with HRT, on the arterial walls and on the sensitivity to insulin in postmenopausal women.
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2011
    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
    United Kingdom: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    22
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited between March 2011 and February 2012

    Pre-assignment
    Screening details
    		 The investigators aimed to recruit 20 postmenopausal women to wear the testosterone patch for 3 months, finally managed recruit 22 participants, 1 patient withdrew before commencing study drug

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Intrinsa Transdermal testosterone patch
    Arm description
    		 Participants received Intrinsa Transdermal testosterone patch
    Arm type
    		 Experimental

    Investigational medicinal product name
    Intrinsa Transdermal testosterone patch
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Transdermal use
    Dosage and administration details
    300 microgram transdermal testosterone patch, applied twice weekly for 12 weeks

    Number of subjects in period 1 [1]
    		Intrinsa Transdermal testosterone patch
    Started
    21
    Completed
    21
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 1 participant withdrew before the treatment

    Baseline characteristics

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

    Reporting group values
    		 Overall period Total
    Number of subjects
    		 21 21
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 53 ( 6.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 21 21
        Male
    		 0 0
    Augmentation Index
    Peripheral pressure waveforms were captured using radial artery application tonometry via the SphygmoCor apparatus (software version 8.0). The central pressure waveform was then derived from an averaged peripheral waveform using a validated, transfer function . The augmentation index (AIx), which gives a composite measure of wave reflection and systemic arterial stiffness can be calculated by analysis of the central waveform. Aix was defined as the difference between the first and second systolic peaks of the central pressure waveform, expressed as a percentage of the cent
    Units: percentage of Arterial stiffness
        geometric mean (standard deviation)
    		 24.21 ( 10.70 ) -
    Reactive Hyperaemia Index
    Reactive Hyperaemia Index (RHI) was calculated automatically by the EndoPAT 2000 computer algorithm from the ratio of pulse wave amplitude before and after ischemia, compared to the control arm. Official reference values do not exist however a lower RHI (<2.0) is usually considered indicative of endothelial dysfunction.
    Units: Unit on the scale
        geometric mean (standard deviation)
    		 1.79 ( 0.36 ) -
    Brief Profile of Female Sexual Function (B-PFSF)
    Blood samples were taken for fasting glucose and insulin levels. From these results, insulin resistance was then estimated using the updated homeostasis model assessment method for insulin resistance (HOMA-IR) computer algorithm. A higher HOMA-IR indicates a higher degree of insulin resistance. Typically a cutoff of HOMA-IR for identifying those with insulin resistance is 2.5.
    Units: Unit on the scale
        geometric mean (standard deviation)
    		 15.3 ( 9.1 ) -
    Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
    Libido was assessed at each visit using the Brief profile of female sexual function (BPFSF), a validated self-administered questionnaire for identifying Hypoactive Sexual Desire Disorder (HSDD). The BPFSF is based on 7 questions. Each question is scored on a 6-point scale from 'always' to 'never'. A total score is calculated from the sum of all questions. Previous studies have identified a score of less than 20 as suggestive of HSDD.
    Units: Unit on the scale
        geometric mean (standard deviation)
    		 0.78 ( 0.40 ) -

    End points

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    End points reporting groups
    Reporting group title
    Intrinsa Transdermal testosterone patch
    Reporting group description
    		 Participants received Intrinsa Transdermal testosterone patch

    Primary: Arterial Compliance - Augmentation Index

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    End point title
    		 Arterial Compliance - Augmentation Index [1]
    End point description
    Peripheral pressure waveforms were captured using radial artery application tonometry via the SphygmoCor apparatus (AtCor Medical Ltd., Sydney, Australia; software version 8.0). The central (ascending aortic) pressure waveform was then derived from an averaged peripheral waveform using a validated, transfer function. The augmentation index (AIx), which gives a composite measure of wave reflection and systemic arterial stiffness can then be calculated by analysis of the central waveform. Aix was defined as the difference between the first and second systolic peaks of the central pressure waveform, expressed as a percentage of the central pulse pressure.
    End point type
    Primary
    End point timeframe
    12 weeks from baseline
    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: A pilot study no statistical analyses.
    End point values
    		 Intrinsa Transdermal testosterone patch
    Number of subjects analysed
    21
    Units: percentage of Arterial stiffness
        geometric mean (confidence interval 95%)
    1.067 (-3.85 to 1.72)
    No statistical analyses for this end point

    Primary: Endothelial function

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    End point title
    		 Endothelial function [2]
    End point description
    Reactive Hyperaemia Index (RHI) was calculated automatically by the EndoPAT 2000 computer algorithm from the ratio of pulse wave amplitude before and after ischemia, compared to the control arm. Official reference values do not exist however a lower RHI (<2.0) is usually considered indicative of endothelial dysfunction.
    End point type
    Primary
    End point timeframe
    12 weeks from baseline
    Notes
    [2] - 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: A pilot study no statistical analyses.
    End point values
    		 Intrinsa Transdermal testosterone patch
    Number of subjects analysed
    17
    Units: units on a scale
        geometric mean (confidence interval 95%)
    0.06 (-0.19 to 0.31)
    No statistical analyses for this end point

    Secondary: Insulin resistance - HOMA-IR

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    End point title
    		 Insulin resistance - HOMA-IR
    End point description
    Blood samples were taken for fasting glucose and insulin levels. From these results, insulin resistance was then estimated using the updated homeostasis model assessment method for insulin resistance (HOMA-IR) computer algorithm. A higher HOMA-IR indicates a higher degree of insulin resistance. Typically a cutoff of HOMA-IR for identifying those with insulin resistance is 2.5.
    End point type
    Secondary
    End point timeframe
    12 weeks from baseline
    End point values
    		 Intrinsa Transdermal testosterone patch
    Number of subjects analysed
    21
    Units: units on a scale
        geometric mean (confidence interval 95%)
    0.106 (-0.20 to 0.41)
    No statistical analyses for this end point

    Secondary: Libido - B-PFSF score

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    End point title
    		 Libido - B-PFSF score
    End point description
    Libido was assessed at each visit using the Brief profile of female sexual function (BPFSF), a validated self-administered questionnaire for identifying Hypoactive Sexual Desire Disorder (HSDD). The BPFSF is based on 7 questions. Each question is scored on a 6-point scale from ‘always’ to ‘never’. A total score is calculated from the sum of all questions. Previous studies have identified a score of less than 20 as suggestive of HSDD.
    End point type
    Secondary
    End point timeframe
    12 weeks from baseline
    End point values
    		 Intrinsa Transdermal testosterone patch
    Number of subjects analysed
    21
    Units: unit on scale
        geometric mean (confidence interval 95%)
    5.05 (2.63 to 7.46)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Intrinsa Transdermal testosterone patch
    Reporting group description
    		 Participants received Intrinsa Transdermal testosterone patch

    Serious adverse events
    		 Intrinsa Transdermal testosterone patch
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 21 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Intrinsa Transdermal testosterone patch
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 21 (33.33%)
    Eye disorders
    Blepharitis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Reproductive system and breast disorders
    per vagina spotting
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Skin irritation
         subjects affected / exposed
    4 / 21 (19.05%)
         occurrences all number
    4
    Acne
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Endocrine disorders
    Increased facial hair
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Feb 2011
    Remove the exclusion Criteria of having received testosterone implants within the last 12 months or other androgen therapy within the last 3 months (from 6 months in the earlier protocol).

    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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    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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