Hormones and Cognition in the Menopausal Transition

Completed

Conditions studied: Age-associated Memory Impairment, Alteration of Cognitive Function

In brief

The purpose of this study is to determine if the menopausal transition is associated with subjective and objective cognitive declines that ameliorate in menopause. The investigators hypothesize that perimenopause is associated with both subjective memory complaints and objective declines in attentionally mediated cognitive tasks. The investigators also hypothesize that this is time-limited. The investigators predict that as women transition from early perimenopause to late perimenopause their performance on attentionally mediated and verbal memory tasks will decline, and that as they transition from late perimenopause to menopause, their performance will improve.

Key facts

Study ID

NCT01429103

Run by

University of Rochester

People needed

117

Starts

2011-05-01

Expected to finish

2016-11-01

Last updated by the study team

2017-03-01

Who can join

Age: 40 and older, up to 60. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Menopausal status will be based on self-report of menstrual cycles over the past 12 months. Early perimenopause is defined as the presence of irregular periods (cycle length differs by 7 days from usual). Late perimenopause is defined as at least 2 skipped periods over the past 12 months (cycle double usual length) and one period of amenorrhea (over 60 days without a period), with at least one menstrual cycle over the past 12 months, according to the Stages of Reproductive Aging Workshop criteria.

You may not qualify if…

• history of neurological disease known to affect cognitive function (i.e., stroke, MS, etc) and major psychiatric illness. The investigators will exclude women who are currently pregnant or breast-feeding, have undergone surgical menopause, or who have used exogenous hormone preparations affecting ovarian or pituitary function in the past 3 months. The investigators will also exclude women who have had hysterectomies, but intact ovaries, or oophorectomies. Women who choose to initiate HRT at some point during the study will continue to be followed, but their data obtained after HRT is initiated will be analyzed separately.

Where it is running

• University of Rochester Clinical Research Center — Rochester, New York, United States

Full record on ClinicalTrials.gov

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