Trials / Completed
CompletedNCT01429103
Hormones and Cognition in the Menopausal Transition
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 117 (actual)
- Sponsor
- University of Rochester · Academic / Other
- Sex
- Female
- Age
- 40 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
Two groups of women will be recruited, those in early perimenopause and those in mid to late perimenopause. Tests of attention, working memory, mental flexibility, processing speed, and retentive memory will be administered to each subject at 6 month intervals for 5 years. Additionally, women will be asked to fill out questionnaires about their mood, memory functioning, health, and quality of life. The investigators will also calculate each subject's Body Mass Index (BMI) and waist circumference at each visit. Finally, serum levels of reproductive hormones will be taken. Measures of interest will be the percentage of women in each group with absolute and relative cognitive deficits, change over time in performance on neuropsychological tests and scores on depression and anxiety scales, and correlations between cognitive function, mood and hormone level.
Conditions
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2016-11-01
- Completion
- 2016-11-01
- First posted
- 2011-09-05
- Last updated
- 2017-03-01
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01429103. Inclusion in this directory is not an endorsement.