Quality of Life Clinical Trial
Official title:
The Quality of Life in Late Menopause. A Seventeen Years Follow-up Study.
The purpose of this study is to evaluate the quality of life of late postmenopausal Finnish women and the factors affecting it.
The aim of this study is to investigate the quality of life (QoL) of late postmenopausal
Finnish women. In 1995, 71 women were recruited through an advertisement in a local
newspaper in the area of Turku in Finland. Exclusion criteria were: a history of previous
head injury, neurological, cardiovascular, endocrinological or mental disease, medicated
hyperlipidemia, malignancies, abuse of alcohol or medicines and smoking (over 10 cigarettes
daily). Inclusion criteria were: previous hysterectomy for a benign reason and
postmenopausal status (serum follicle stimulating hormone (FSH) level over 26 U/l). Finally,
65 women were approved for the study.
Originally the study was a prospective, randomized, placebo-controlled, double-blind,
cross-over trial. It included three different periods in which different medications were
administered: three months of estrogen/placebo therapy, a one month wash-out period and
three months of placebo/estrogen therapy. The women were randomized into two groups, where
the other group received first a placebo and then estrogen and the other received first
estrogen and then a placebo. Women completed questionnaires at the beginning of the study
and after the both periods. After the survey women got to choose if they wanted to continue
with the hormone replacement therapy (HRT) or not.
Questionnaires were sent to the same women six years later. The intention was to estimate
the present QoL of the women. Also their use of HRT, possible chronic diseases and
medications were evaluated.
This study is the 17 year follow-up study to the investigation described above. The goal is
to measure the QoL of the same women and estimate the factors affecting it in late
postmenopausal age. The questionnaires used are the Women's Health Questionnaire (WHQ), the
Beck Depression Inventory (BDI), the Basic Nordic Sleep Questionnaire (BNSQ) and a common
questionnaire to define the women's current life situation, their education and working
background, their state of health, medications, the use of HRT and recent life events. The
women also filled in the same questionnaires 17 years ago in relation to the first part of
the study, and six years after it relating to the first follow-up study. The results of this
study are compared to the former investigation results. The above mentioned randomization
system is not used this time but the women are processed as only one group. The women are
now acting as their own controls and their answers are compared to the responses they gave
17 years earlier. In this way it is possible to determine, if the woman's QoL has changed
during aging, and if the change is for the better or worse. The women were already
postmenopausal 17 years ago, so the effect of climacterium should be bypassed by now.
Therefore, when the results of this study are compared to the former results, it is possible
to separate the effect of the climacterium, and on the other hand, the effects of aging, on
the QoL and on some symptoms attached to the perimenopausal phase.
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Time Perspective: Prospective
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