Testosterone Patch's Effects on the Cardiovascular System and Libido
Condition: Hypoactive Sexual Desire Disorder
MeSH terms: Hypokinesia; Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine the effect of the testosterone patch, in addition to
      hormone replacement therapy (HRT), on blood vessel walls, insulin levels and sexual desire.
    

Detailed description: 
      A woman's ovaries produce the hormone testosterone during her reproductive life but
      testosterone levels decline with age or when the ovaries are removed. Testosterone has been
      associated with sexual desire in both men and women. Low testosterone is also believed to
      cause symptoms of low energy. Thus testosterone is increasingly used in hormone replacement
      regimens to restore libido and energy in postmenopausal women.

      In the past testosterone has been administered orally or via subcutaneous implants. Recently
      testosterone patches have been licensed for treating low libido in postmenopausal women. The
      testosterone patches deliver a dose of testosterone equivalent to the levels produced by the
      ovary during a woman's early reproductive years.

      Oral testosterone can lead to changes to insulin and cholesterol levels which increase the
      risk of heart disease. On the contrary, testosterone patches may reduce or avoid this risk.
      To date, trials have predominantly focused on safety data in terms of side effects and basic
      blood tests. Reviews of the safety of testosterone replacement have emphasised the need for
      improved safety data, especially in terms of cardiovascular risk.

      The investigators hypothesis that transdermal testosterone, in addition to HRT, will have no
      adverse effects on blood vessel walls and insulin levels and that transdermal testosterone
      significantly improves sexuality and psychological well-being in postmenopausal women.

      Trial design:

      The investigators aim to recruit 20 postmenopausal women to wear the testosterone patch for 3
      months in addition to their usual hormone replacement therapy.

      There will be 3 study visits - a pre study visit, week 6 and week 12. At each visit the
      following procedures will be performed:

        -  Medical history and physical examination

        -  Blood sample - for hormone levels, lipids and insulin levels

        -  Blood vessel stiffness measurements This will be performed using a small ultrasound
           device at the wrist with blood pressure measured every 5 minutes.

        -  Endothelial function (function of your arterial wall) is measured using a blood pressure
           cuff on each arm and finger probes on one finger of each hand. The blood pressure cuff
           is inflated for 5 minutes and is then deflated quickly. The finger probes will record
           the readings throughout this study.

        -  Sexual satisfaction questionnaire
    

Intervention name(s): Intrinsa Transdermal testosterone patch
Intervention type(s): Drug
Intervention description(s): 300 microgram transdermal testosterone patch, applied twice weekly for 12 weeks
Other intervention name(s): Intrinsa
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Hypoactive sexual desire disorder