Pilot Study: Evaluating the effect of 300microgram testosterone patches in addition to Hormone Replacement Therapy on arterial compliance, insulin resistance and sexual desire - Testosterone Patch's effects on cardiovascular system & libido (pilot)

Phase 1

• Conditions: Arterial compliance Insulin sensitivity Decreased sexual desire after menopause; MedDRA version: 9.1 Level: LLT Classification code 10020112 Term: Hirsutism; MedDRA version: 9.1 Level: LLT Classification code 10001763 Term: Alopecia, reversible; MedDRA version: 9.1 Level: LLT Classification code 10000496 Term: Acne; MedDRA version: 9.1 Level: LLT Classification code 10059294 Term: Oily skin; MedDRA version: 9.1 Level: LLT Classification code 10028813 Term: Nausea; MedDRA version: 9.1 Level: LLT Classification code 10040880 Term: Skin irritation

• Registration Number: EUCTR2009-013275-21-GB
• Lead Sponsor: Imperial College Healthcare NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-04
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 20

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, 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 principle purpose of this study is to examine the effects of the testosterone patch, in conjuction with HRT, on the arterial walls and on the sensitivity to insulin in postmenopausal women.;<br> Secondary Objective: The seconday objectives are to examine the effects of the testosterone patch, in conjuction with HRT,on libido in postmenopausal women.<br><br> In addition, the study will be used to assess the feasibilty of a randomised controlled trail to further investigate the effects of the testosterone patch on arterial walls and insulin sensitivity, following a similar protocol.<br> ;Primary end point(s): The primary outcome is the effect of testosterone patches on arterial compliance and insulin resistance.