Menopausal disorders Urological and Genital Diseases Menopausal disorders
Conditions
Interventions
Blind group: The active drug is orally administered conjugated oestrogen 0.625 mg plus Medroxyprogesterone Acetate (MPA) 2.5 mg, taken every day (women within 3 years of their last period will receive
Sponsors
National Research and Development Centre for Welfare and Health (STAKES) (Finland)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged 50 - 64 years 2. Last period at least 12 months before recruitment
Exclusion criteria
Exclusion criteria: Women with the following characteristics and health problems, as reported by women themselves or reported in patient records or health registers or found during the clinical examination are excluded from the study: 1. Current HT in last six months 2. Menstrual period within the last 12 months 3. Untreated endometrial adenomatosis or atypical hyperplasia of endometrium 4. Breast cancer, endometrial cancer, ovarian cancer 5. Any cancer treated less than 5 years ago 6. History of meningioma 7. Myocardial infarction within the last 6 months 8. History of hepatitis (not hepatitis A) or liver functional disorders during last 3 months 9. History of deep vein thrombosis, pulmonary embolism, cerebral infarction 10. Porphyria 11. Hypertension in spite of medication more than 170/110 mmHg 12. Endometriosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Health effects: 1.1. The sum of major ischaemic heart diseases events (fatal and non-fatal myocardial infarction and sudden coronary death) and of stroke 1.2. The sum of major fractures 1.3. Mortality and incidence of breast cancer and other cancers. In case of breast cancer the stage and type of cancer will be specified 1.4. Deaths from all causes 2. Immediate and long-term effects on well-being and quality of life: data from the annual questionnaires including Women's Health Questionnaire (WHQ), EQ-5D scores, self-rated health status, list of symptoms 3. Effects on the experience of the climacteric and aging and partner relationship: data from the annual questionnaires 4. Effects on health services: 4.1. Inpatient health care costs 4.2. Outpatient health care costs 4.3. Costs of prescribed drugs 4.4. Costs of sickness leaves 4.5. Total number of health care visits 4.6. Number of visits to gynaecologists 4.7. Number of visits to family practitioners 4.8. Number of hospital care days 4.9. Number of hospitalisations 4.10. Number of days on sickness leave 4.11. Number of selected medical procedures 5. Methodological outcomes: 5.1. Recruitment rates 5.2. Adherence rates 5.3. Differences between the trial arms regarding outcomes in health effects, quality of life, health care use, well-being, symptoms and social effects | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Estonia
Outcome results
None listed