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Hormone therapy in menopausal women with cognitive complaints

A randomized, double-blind trial

From the Departments of Psychiatry and Psychology (P.M.M.), University of Illinois at Chicago; Wyeth Pharmaceuticals (M.J.G., A.J.V., S.W.B.), Collegeville, PA; and Department of Psychiatry, Neurology, and Epidemiology (K.Y.), University of California, San Francisco.

Address correspondence and reprint requests to Dr. Michael J Gast, 111 Augusta Drive, West Chester, PA 19382 WA2281{at}aol.com

Objective: To evaluate the effects of hormone therapy (HT) on cognition and subjective quality of life (QoL) in recently postmenopausal women with cognitive complaints.

Methods: Cognitive Complaints in Early Menopause Trial (COGENT) was a randomized, double-blind, placebo-controlled, multicenter, pilot study of 180 healthy postmenopausal women aged 45 to 55 years, randomly assigned to receive either placebo or conjugated equine estrogen 0.625 mg/medroxyprogesterone acetate 2.5 mg for 4 months. Outcome measures included memory, subjective cognition, QoL, sexuality, and sleep, which were assessed at baseline and month 4.

Results: The study was terminated before the expected final sample size of 275 due to a decrease in enrollment coinciding with the publication of findings from the Women’s Health Initiative. There were no differences between groups on any cognitive or QoL measures, except for an increase in sexual interest and thoughts with HT. Modest negative effects on short- and long-term verbal memory approached significance (p < 0.10). Women with baseline vasomotor symptoms (VMS) showed a decrease in VMS and an improvement in general QoL, but no cognitive benefit vs placebo.

Conclusions: With the power to detect an effect size of 0.45, this study suggests potential modest negative effects on verbal memory that are consistent with previous hormone therapy trials in older women.

GLOSSARY: BTA = Brief Test of Attention; BVRT = Benton Visual Retention Test; COGENT = Cognitive Complaints in Early Menopause Trial; CRT = Educational Testing Service Card Rotation Test; CVLT = California Verbal Learning; FAS = Letter Fluency Test; HERS = Heart and Estrogen/progestin Replacement Study; HT = hormone therapy; MFSQ = McCoy Female Sexuality Scale Questionnaire; MFQ = The Memory Functioning Questionnaire; PANAS = Positive and Negative Affect Scale; PSQI = The Pittsburgh Sleep Quality Index; QoL = subjective quality of life; SWAN = Study of Women’s Health Across the Nation; UQoL = Utian Quality of Life; VMS = vasomotor symptoms Test; WHI = Women’s Health Initiative; WHISCA = WHI Study of Cognitive Aging; WMS-R/DGT-F, MS-R/DGT-B = Digit Span Forward and Backward Subtests of the Wechsler Memory Scale–Revised.

Disclosure: This study was funded by Wyeth, Collegeville, PA. Prempro is manufactured and marketed by Wyeth. Dr. Maki has received grants (in excess of $10,000) and honoraria from Wyeth. Dr. Yaffe has received grants (in excess of $10,000) and honoraria from Wyeth. Dr. Gast, A.J. Vieweg, and S.W. Burriss are current or former employees of Wyeth. Dr. Gast has ownership interest in the company. Dr. Yaffe received compensation through the University of California for her role as a consultant throughout the trial.

Received July 12, 2006. Accepted in final form April 19, 2007.

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