A randomised, placebo controlled, double blind study to evaluate the effect of 300mcg testosterone patches in addition to HRT on arterial compliance, insulin resistance and sexual desire. - Testosterone Patch's effect on the Cardiovascular system and libido.

• Conditions: - arterial compliance- insulin resistance- decreased sexual desire after menopause; MedDRA version: 9.1Level: LLTClassification code 10020112Term: Hirsutism; MedDRA version: 9.1Level: LLTClassification code 10001763Term: Alopecia reversible; MedDRA version: 9.1Level: LLTClassification code 10000496Term: Acne; MedDRA version: 9.1Level: LLTClassification code 10059294Term: Oily skin; MedDRA version: 9.1Level: LLTClassification code 10028813Term: Nausea; MedDRA version: 9.1Level: LLTClassification code 10040880Term: Skin irritation

• Registration Number: EUCTR2007-005911-25-GB
• Lead Sponsor: Imperial College Healthcare NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:

•healthy postmenopausal women
•45 to 70 years of age
•on HRT and willing to continue the same HRT regimen for the next 6
months
•are in a stable relationship which was started at least 6 months ago
•continue on any concomitant medications without any change during the
study
•give informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion Criteria:

•have dyspareunia
•have received testosterone implants within the last 12 months or other
androgen therapy within the last 6 months
•have received any medications which may interfere with the study (SSRI,
anti-androgens, PDE5 inhibitors, DHEA, SERMS)
•have a significant psychiatric disorder
•have a history of breast cancer
•have diabetes, thromboembolic disorders, cardiovascular disease or any
condition affecting carbohydrate metabolism, uncontrolled hypertension and uncontrolled hyperlipidaemia
•are on tibolone (due to its androgenic effect).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of this study is to determine the effect of postmenopausal transdermal testosterone in conjunction with HRT on the cardiovascular system by assessing insulin resistance and arterial compliance.<br>;Secondary Objective: The secondary objective is to determine the effect of postmenopausal transdermal testosterone in conjunction with HRT on libido by assessing sexual functioning.<br><br>;Primary end point(s): The primary end points are the effects of testorone patches on arterial compliance and insulin resistance. <br><br>Arterial compliance will be studied by applanation tonometry of the radial artery before and after salbutamol inhalation and sublingual GTN administration. Endothelial function assessments will also be carried out using digital volume changes following reactive hyperaemia .<br><br>Insulin resistance will be studied by means of Oral Glucose Tolerance Tests.