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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

Davison, Sonia L. MBBS, FRACP, PhD1; Bell, Robin J. MBBS, PhD, MPH, FAFPHM1; Robinson, Penelope J. MBiostat1; Jane, Fiona MBBS1; Leech, Jennifer BSc2; Maruff, Paul PhD3,4; Egan, Gary F. BSc, MBA, PhD4,5; Davis, Susan R. MBBS, FRACP, PhD1

doi: 10.1097/GME.0b013e318287474f
Original Study

Objective: This study aimed to explore the effects of continuous-combined estradiol 1 mg/drospirenone 2 mg (E2D) on cognitive performance in healthy, recently postmenopausal women.

Methods: A 6-month randomized, double-blind, placebo-controlled study was carried out in a university research center. Participants were 23 healthy postmenopausal women aged 49 to 55 years. Cognitive performance was assessed with a computerized cognitive battery administered to all participants on 0, 12, and 26 weeks. Functional magnetic resonance imaging was performed on 13 participants before and after treatment using tasks of verbal fluency and mental rotation.

Results: E2D was not associated with an overall effect on cognitive performance. Functional magnetic resonance imaging results showed no difference between the groups for verbal fluency or mental rotation task performance at baseline. The mental rotation task was associated with increased blood oxygen level–dependent signalling in the placebo group in both occipital lobes and in the left superior parietal lobe after 26 weeks (P < 0.05), with no changes over time seen in the treatment group. The total menopausal symptom and sexual function domain scores improved after treatment in women randomized to E2D compared with the placebo group (both P < 0.05). Similarly, systolic blood pressure, weight, and body mass index were significantly lower in women randomized to E2D at 26 weeks (P < 0.05).

Conclusions: E2D has no detrimental effect on cognitive performance in early postmenopausal women. E2D significantly improves menopausal symptoms, sexual function, systolic blood pressure, and weight.

From the 1Women’s Health Research Program, Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; 2The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Victoria, Australia; 3CogState Ltd, Melbourne, Victoria, Australia; 4Center for Neuroscience, University of Melbourne, Parkville, Victoria, Australia; and 5Monash Biomedical Imaging, Monash University, Melbourne, Victoria, Australia.

Received November 2, 2012; revised and accepted January 10, 2013.

Australian New Zealand Clinical Trials Registration: ACTRN12608000201370.

Funding/support: This study was supported by Bayer Pharma AG (Berlin, Germany), which provided study medications and funding for the study. S.R.D. is a principal research fellow of the Australian National Health and Medical Research Council (grant 490939). No funding was provided for the analyses undertaken by the authors.

Financial disclosure/conflicts of interest: S.R.D. has served as a consultant to BioSante USA and Trimel CA and has received research funding from Bayer Pharma and BioSante USA. S.L.D. is a member of the speakers’ bureau for Jean Hailes for Women’s Health, receives paymentfor the preparation and delivery of women’s health presentations, and has received payment for the development of an educational presentation for Lawley Pharmaceuticals Pty Ltd. P.M. is a paid employee of CogState Ltd. J.L. served as research assistant at the Florey Institute during project design and data collection, for which she and the institute received payment.

The other authors declare no conflicts of interest.

Address correspondence to: Susan R. Davis, MBBS, FRACP, PhD, Women’s Health Research Program, School of Public Health and Preventive Medicine, Monash University, Level 6, The Alfred Center, 99Commercial Road, Melbourne, VIC 3004, Australia. E-mail: Susan.Davis@monash.edu

© 2013 by The North American Menopause Society.