EUCTR2009-013275-21-GBActive, not recruitingPhase 1
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)
Imperial College Healthcare NHS Trust0 sites20 target enrollmentStarted: September 4, 2009Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility 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:
- •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).
Investigators
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