The effect of transdermal testosterone patch (Intrinsa registered trademark) on cognitive performance in older postmenopausal women: a randomized placebo controlled trial over 26 weeks.
- Conditions
- cognitionMental Health - Studies of normal psychology, cognitive function and behaviour
- Registration Number
- ACTRN12610000029099
- Lead Sponsor
- Monash University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 120
Healthy postmenopausal women aged 65 to 70 years, on no hormone therapy (HRT).
Any hormone therapy in the past 12 months (i.e. systemic oestrogen, testosterone, tibolone, or dehydroepiandrosterone acetate [DHEA]) excluding topical vaginal oestrogens. Past or present history of cancer, significant disease of the heart, liver, or kidneys, serious endocrine (hormone) disorder, androgenic alopecia (loss of scalp hair in a male pattern) or use of anti-androgen therapy, epilepsy, seizures, psychiatric illness including depression, neurological (nerve, spinal cord or brain) injury including head injury, intellectual disability, uncontrolled hypertension (high blood pressure), major gynaecological (ovarian, vaginal, cervical, womb or uterus) surgery in the preceding 3 months, levels of testosterone higher than the normal reference range for young premenopausal women, use of androgen or anti-androgen therapy, the use of other medication that may interfere with the results of the study. Regular consumption of an excess of alcohol (more than 3 standard drinks per day)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method cognitive performance as assessed by a computerised cognitive battery (CogState)[6 months following randomisation]
- Secondary Outcome Measures
Name Time Method nil[nil]