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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.

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.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000201370
Enrollment
23
Registered
2008-04-15
Start date
2008-11-11
Completion date
2010-09-22
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

administration of 17 beta-oestradiol 1mg and drospirenone 2mg orally once per day for 26 weeks

Sponsors

Women's Health Program, Monash University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
45 Years to 55 Years
Healthy volunteers
Yes

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026