Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Quality of Life in Late Menopause (QoL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01848223
Recruitment Status : Unknown
Verified May 2013 by Turku University Hospital.
Recruitment status was:  Recruiting
First Posted : May 7, 2013
Last Update Posted : May 7, 2013
Sponsor:
Information provided by (Responsible Party):
Turku University Hospital

Tracking Information
First Submitted Date May 2, 2013
First Posted Date May 7, 2013
Last Update Posted Date May 7, 2013
Study Start Date November 2012
Estimated Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 2, 2013)
quality of life [ Time Frame: seventeen years ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Quality of Life in Late Menopause
Official Title The Quality of Life in Late Menopause. A Seventeen Years Follow-up Study.
Brief Summary The purpose of this study is to evaluate the quality of life of late postmenopausal Finnish women and the factors affecting it.
Detailed Description

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.

Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population community sample of the area of Turku
Condition Quality of Life
Intervention Not Provided
Study Groups/Cohorts late menopause
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 2, 2013)
64
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2016
Estimated Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: Female
Ages 64 Years to 82 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Finland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01848223
Other Study ID Numbers T56/2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Turku University Hospital
Study Sponsor Turku University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Riina Katainen, MD University of Turku and Turku University Hospital
Study Director: Päivi Polo, MD,PhD University of Turku and Turku University Hospital
PRS Account Turku University Hospital
Verification Date May 2013