The Quality of Life in Late Menopause (QoL)
The Quality of Life in Late Menopause. A Seventeen Years Follow-up Study.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
-
-
Turku、フィンランド、20100
- 募集
- University of Turku and Turku University Hospital
-
コンタクト:
- Riina Katainen
- 電話番号:+35823130000
- メール:riina.katainen@utu.fi
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- a previous hysterectomy for benign reason
- postmenopausal status (serum follicle stimulating hormone (FSH) level over 26 U/l)
Exclusion Criteria:
- a history of previous head injury
- a chronic somatic or mental disease
- abuse of alcohol or medicines
- smoking (over 10 cigarettes daily)
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
|---|
|
late menopause
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
quality of life
時間枠:seventeen years
|
seventeen years
|
協力者と研究者
捜査官
- 主任研究者:Riina Katainen, MD、University of Turku and Turku University Hospital
- スタディディレクター:Päivi Polo, MD,PhD、University of Turku and Turku University Hospital
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- T56/2013
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。