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
Conditions
Interventions
Trade Name: Intrinsa Testosterone Patch
Product Name: Intrinsa Testosterone Patch
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Testostero
Sponsors
Imperial College Healthcare NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.; Secondary Objective: The seconday objectives are to examine the effects of the testosterone patch, in conjuction with HRT,on libido in postmenopausal women. 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. ;Primary end point(s): The primary outcome is the effect of testosterone patches on arterial compliance and insulin resistance. | — |
Countries
United Kingdom
Outcome results
None listed