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Quality of LifeQoLNCT01848223

The Quality of Life in Late Menopause

An observational study of Quality of Life, run by Turku University Hospital at 1 site in Finland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate the quality of life of late postmenopausal Finnish women and the factors affecting it. Read more about this study

Who is it for?
Ages 64 to 82 years, women only
Conditions the study is for
Quality of Life
How many people
64 participants
Where
1 siteFinland
Study dates
Nov 2012to Dec 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 64 to 82 years
  • Women only
  • Adult, Older adult

Study population: community sample of the area of Turku

Who may be able to join

  • a previous hysterectomy for benign reason
  • postmenopausal status (serum follicle stimulating hormone (FSH) level over 26 U/l)

Who cannot join

  • a history of previous head injury
  • a chronic somatic or mental disease
  • abuse of alcohol or medicines
  • smoking (over 10 cigarettes daily)

Trial locations and contacts

1 site in 1 country.

Riina Katainen contact

+35823130000

riina.katainen@utu.fi

Finland1 site, 1 recruiting
  • University of Turku and Turku University Hospital

    Turku, 20100

    Riina Katainen, +35823130000, riina.katainen@utu.fi

    Recruiting

Other trials in Finland

About this study

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.

Read the 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.

Conditions
Quality of Life
Keywords
quality of life, QoL, late menopause

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01848223
Study groupRoleWhat they receive
late menopauseNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. quality of life

    Measured: seventeen years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2013 (estimated)
  2. Study startNov 2012
  3. Primary completionMay 2014 (estimated)
  4. Study completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01848223
Sponsor's protocol ID
T56/2013
Acronym
QoL
Status last verified
May 2013
First submitted
2 May 2013
Last updated
7 May 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Quality of Life, run by Turku University Hospital at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Riina Katainen (+35823130000, riina.katainen@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

quality of life (time frame: seventeen years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2013.

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