Toward Personalized Sexual Medicine (Part 2): Testosterone Combined with a PDE5 Inhibitor Increases Sexual Satisfaction in Women with HSDD and FSAD, and a Low Sensitive System for Sexual Cues

Authors

  • Saskia Poels MD,

    1. Emotional Brain B.V., Almere, The Netherlands
    2. Utrecht Institute for Pharmaceutical Sciences and Rudolf Magnus Institute of Neuroscience, Utrecht University, Utrecht, The Netherlands
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  • Jos Bloemers MSc,

    1. Emotional Brain B.V., Almere, The Netherlands
    2. Utrecht Institute for Pharmaceutical Sciences and Rudolf Magnus Institute of Neuroscience, Utrecht University, Utrecht, The Netherlands
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  • Kim van Rooij MD,

    1. Emotional Brain B.V., Almere, The Netherlands
    2. Utrecht Institute for Pharmaceutical Sciences and Rudolf Magnus Institute of Neuroscience, Utrecht University, Utrecht, The Netherlands
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  • Irwin Goldstein MD, PhD,

    1. San Diego Sexual Medicine, San Diego, CA, USA
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  • Jeroen Gerritsen MSc,

    1. Emotional Brain B.V., Almere, The Netherlands
    2. Utrecht Institute for Pharmaceutical Sciences and Rudolf Magnus Institute of Neuroscience, Utrecht University, Utrecht, The Netherlands
    3. Department of Psychology, University of Amsterdam, Amsterdam, The Netherlands
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  • Diana van Ham MSc,

    1. Emotional Brain B.V., Almere, The Netherlands
    2. Utrecht Institute for Pharmaceutical Sciences and Rudolf Magnus Institute of Neuroscience, Utrecht University, Utrecht, The Netherlands
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  • Frederiek van Mameren MD,

    1. Department of Gynaecology and Obstetrics, Flevo Hospital, Almere, The Netherlands
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  • Meredith Chivers PhD,

    1. Department of Psychology, Queen's University, Kingston, ON, Canada
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  • Walter Everaerd PhD,

    1. Alan Turing Institute Almere, Almere, The Netherlands
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  • Hans Koppeschaar MD, PhD,

    1. Emotional Brain B.V., Almere, The Netherlands
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  • Berend Olivier PhD,

    1. Utrecht Institute for Pharmaceutical Sciences and Rudolf Magnus Institute of Neuroscience, Utrecht University, Utrecht, The Netherlands
    2. Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA
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  • Adriaan Tuiten PhD

    Corresponding author
    1. Emotional Brain B.V., Almere, The Netherlands
    2. Utrecht Institute for Pharmaceutical Sciences and Rudolf Magnus Institute of Neuroscience, Utrecht University, Utrecht, The Netherlands
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  • Role of funding source: Funding for this study was provided by Emotional Brain B.V.

  • Trial registration: trialregister.nl identifier: NTR1228.

Adriaan Tuiten, PhD, Emotional Brain B.V., Louis Armstrongweg 78, 1311 RL Almere, The Netherlands. Tel: 0031-5-46-83-46; Fax: 0031-5-49-71-86; E-mail: a.tuiten@emotionalbrain.nl

ABSTRACT

Introduction.  Low sexual desire in women may result from a relative insensitivity of the brain for sexual cues. Administration of sublingual 0.5 mg testosterone (T) increases the sensitivity of the brain to sexual cues. Sexual stimulation in the brain is necessary for phosphodiesterase type 5 inhibitor (PDE5i)-mediated increase in genital sexual response. Accordingly, a single dose of T+PDE5i might enhance sexual responsiveness, especially in women with low sensitivity for sexual cues.

Aim.  To assess the hypothesis that treatment with on-demand use of T+PDE5i improves sexual functioning, particularly in women who suffer from Hypoactive Sexual Desire Disorder (HSDD) as the result of a relative insensitivity for sexual cues.

Methods.  In a randomized, double-blind, placebo-controlled, crossover design, 56 women with HSDD underwent three medication treatment regimes (placebo, T+PDE5i, and T with a serotonin 1A receptor agonist; see also parts 1 and 3), which lasted 4 weeks each. In a participant-controlled ambulatory psychophysiological experiment at home (the first week of each drug treatment), physiological and subjective indices of sexual functioning were measured. In a bedroom experiment (the subsequent 3 weeks), sexual functioning was evaluated following each sexual event after the self-administration of study medication. Subjective evaluation of sexual functioning was also measured by weekly and monthly reports.

Main Outcome Measures.  Subjective: sexual satisfaction, experienced genital arousal, sexual desire. Physiological: vaginal pulse amplitude. Cognitive: preconscious attentional bias.

Results.  T+PDE5i, as compared with placebo, significantly improved physiological and subjective measures of sexual functioning during ambulatory psychophysiological lab conditions at home and during the sexual events, in women with low sensitivity for sexual cues.

Conclusions.  The present study demonstrated that on-demand T+PDE5i is a potentially promising treatment for women with HSDD, particularly in women with low sensitivity for sexual cues. Poels S, Bloemers J, van Rooij K, Goldstein I, Gerritsen J, van Ham D, van Mameren F, Chivers M, Everaerd W, Koppeschaar H, Olivier B, and Tuiten A. Toward personalized sexual medicine (part 2): Testosterone combined with a PDE5 inhibitor increases sexual satisfaction in women with HSDD and FSAD, and a low sensitive system for sexual cues. J Sex Med 2013;10:810–823.

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