Overview

Testosterone Patch's Effects on the Cardiovascular System and Libido

Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Imperial College Healthcare NHS Trust
Collaborators:
Chelsea and Westminster NHS Foundation Trust
Royal Brompton & Harefield NHS Foundation Trust
Treatments:
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
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.

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, any condition
affecting carbohydrate metabolism, uncontrolled hypertension and uncontrolled
hyperlipidaemia

- are on tibolone (due to its androgenic effect).