None listed
Conditions
Interventions
Trade Name: Intrinsa
Product Name: Intrinsa testosterone patch
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: TESTOSTERONE
CAS Number: 58220
Other descriptive name: Intrinsa testosterone
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 or 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 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. ;Secondary Objective: The secondary objective is to determine the effect of postmenopausal transdermal testosterone in conjunction with HRT on libido by assessing sexual functioning. ;Primary end point(s): The primary end points are the effects of testorone patches on arterial compliance and insulin resistance. 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 . Insulin resistance will be studied by means of Oral Glucose Tolerance Tests. | — |
Countries
United Kingdom
Outcome results
None listed