Status:
COMPLETED
Testosterone Patch's Effects on the Cardiovascular System and Libido
Lead Sponsor:
Imperial College Healthcare NHS Trust
Collaborating Sponsors:
Royal Brompton & Harefield NHS Foundation Trust
Chelsea and Westminster NHS Foundation Trust
Conditions:
Hypoactive Sexual Desire Disorder
Eligibility:
FEMALE
45-70 years
Phase:
PHASE4
Brief 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 d...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01208038
Start Date
March 1 2011
End Date
February 1 2012
Last Update
January 2 2020
Active Locations (3)
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1
Chelsea and Westminster Hospital
London, United Kingdom, SW10 9NH
2
Queen Charlotte's and Chelsea Hospital
London, United Kingdom, W14 0HS
3
Royal Brompton Hospital
London, United Kingdom