Testosterone Patch's effects on cardiovascular system & libido (pilot)

• Research type

  Research Study

• Full title

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

• IRAS ID

  26123

• Contact name

  Nick Panay

• Sponsor organisation

  Imperial College Healthcare NHS Trust

• Eudract number

  2009-013275-21

• ISRCTN Number

  not issued

• Research summary

  The aim of the study is to determine the effects of the testosterone patch, when used in conjunction with Hormone Replacement Therapy (HRT), on the arterial walls and on insulin sensitivity, in post-menopausal women. It will also assess the impact of testosterone replacement on libido.This study will act as a feasibility study with the aim to progressing to a randomised placebo-controlled trial.Reduction in testosterone in postmenopausal women is associated with reduced libido and testosterone replacement is increasingly used as treatment. Data on the safety of testosterone replacement on the cardiovascular system and on insulin sensitivity are presently limited and further research is needed on the subject.We aim to recruit 20 postmenopausal women already using HRT, who are normally fit and well, to use the testosterone patch for 3 months. The women will be age 45 to 70, willing to continue their current HRT for 6 months and are in a stable relationship. All patients will be asked to give informed consent.We will perform investigations before, during and after the treatment to assess its impact. The investigations will involve blood pressure measurement, waist and hip measurements and blood tests for hormone, glucose and insulin levels. The arterial function will be assessed by 2 non-invasive tests. Firstly using a finger probe to assess changes in blood flow whilst a blood pressure cuff is inflated and secondly using ultrasound to look at the character of the radial pulse. Finally, a questionnaire will be used to assess libido. The study will involve 3 visits over 12 weeks, each lasting between 1-2 hours and will be conducted in NHS hospital sites.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  09/H0707/68

• Date of REC Opinion

  2 Dec 2009

• REC opinion

  Further Information Favourable Opinion