A randomized double-blind placebo-controlled trial to assess the effects of 17 beta-oestradiol 1mg + drospirenone 2mg administration on cognitive function in early postmenopausal women.
- Conditions
- cognitionNeurological - Other neurological disorders
- Registration Number
- ACTRN12608000201370
- Lead Sponsor
- Women's Health Program, Monash University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 40
healthy postmenopausal women on no hormonal replacement therapy for the previous 12 months, who have had at least 12 months of amenorrhea but no more than 5 years of amenorrhea or who have become surgically menopausal by bilateral oophorectomy at least 4 weeks previously.
history of cancer in past 5 years excluding non-melanotic skin cancer; deep venous thrombosis; pulmonary embolism, retinal vein thrombosis;significant heart, liver, kidney endocrine or neurological disease; significant head injury, epilepsy, cerebral tumour, stroke, previous intracranial surgery, Parkinson's disease, multiple sclerosis, intellectual disability; uncontrolled hypertension; undiagnosed genital bleeding; severe depression, severe psychiatric illness, current use of antidepressant medication; current smoking history, alcohol consumption greater than 3 standard drinks per day; no mammogram or Pap Smear in past 2 years or Body Mass Index <18 or >40kg/m^2
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method effects on cognition as measured by functional Magnetic Resonance Imaging (fMRI)[26 weeks]
- Secondary Outcome Measures
Name Time Method effects on cognition as measured by Cogstate[26 weeks]