Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000201370
Ethics application status
Approved
Date submitted
11/04/2008
Date registered
15/04/2008
Date last updated
18/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 283945 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cognition 3039 0
Condition category
Condition code
Neurological 3191 3191 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
administration of 17 beta-oestradiol 1mg and drospirenone 2mg orally once per day for 26 weeks
Intervention code [1] 2784 0
Treatment: Drugs
Comparator / control treatment
placebo - sugar pill. Orally once per day for 26 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 4078 0
effects on cognition as measured by functional Magnetic Resonance Imaging (fMRI)
Timepoint [1] 4078 0
26 weeks
Secondary outcome [1] 6873 0
effects on cognition as measured by Cogstate
Timepoint [1] 6873 0
26 weeks

Eligibility
Key inclusion criteria
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.
Minimum age
45 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who was at central administration
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2008
Actual
11/11/2008
Date of last participant enrolment
Anticipated
Actual
22/09/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 3290 0
Commercial sector/Industry
Name [1] 3290 0
Bayer Schering Pharma
Country [1] 3290 0
Australia
Primary sponsor type
University
Name
Women's Health Program, Monash University
Address
Monash Medical School
Alfred Hospital
Commercial Rd
Prahran 3181
Country
Australia
Secondary sponsor category [1] 2945 0
None
Name [1] 2945 0
Address [1] 2945 0
Country [1] 2945 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5276 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 5276 0
Human Ethics Office First Floor,
Building 3E, Room 111
Monash University Clayton Campus,
Wellington Rd, Clayton,
VIC 3800
Ethics committee country [1] 5276 0
Australia
Date submitted for ethics approval [1] 5276 0
30/05/2008
Approval date [1] 5276 0
04/09/2008
Ethics approval number [1] 5276 0
CF08/1572 - 2008000801

Summary
Brief summary
A 26 week study to assess the efficacy of 17 beta-oestradiol and drosperinone on cognitive function in healthy postmenopausal women aged 45-55 years.
Trial website
http:womenshealth.med.monash.edu.au
Trial related presentations / publications
Davison SL, Bell RJ, Robinson PJ, Jane F, Leech J, Maruff P, Egan GF, Davis SR. Continuous-combined oral estradiol/drospirenone has no detrimental effect on cognitive performance and improves estrogen deficiency symptoms in early postmenopausal women: a randomized placebo-controlled trial. Menopause. 2013 Oct;20(10): 1020-1026
Public notes

Contacts
Principal investigator
Name 28521 0
Prof Susan Davis
Address 28521 0
Women's Health Research Program
Monash University
Level 6, The Alfred Centre
99 Commercial Rd
Melbourne Victoria 3004
Country 28521 0
Australia
Phone 28521 0
+61 3 99030827
Fax 28521 0
+613 99030828
Email 28521 0
[email protected]
Contact person for public queries
Name 11678 0
Prof Susan Davis
Address 11678 0
Women's Health Research Program
Monash University
Level 6, The Alfred Centre
99 Commercial Rd
Melbourne Victoria 3004
Country 11678 0
Australia
Phone 11678 0
+61 3 9903 0837
Fax 11678 0
+61 3 9903 0828
Email 11678 0
[email protected]
Contact person for scientific queries
Name 2606 0
Prof Susan Davis
Address 2606 0
Women's Health Research Program
Monash University
Level 6, The Alfred Centre
99 Commercial Rd
Melbourne Victoria 3004
Country 2606 0
Australia
Phone 2606 0
+61 3 9903 0827
Fax 2606 0
+61 3 9903 0828
Email 2606 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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