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| [ ...Back to search results ] | [ Print-friendly version ] |
| Advantages and disadvantages of postmenopausal hormone therapy: a preventive trial - the Estonian Postmenopausal Hormone Therapy trial |
| ISRCTN | ISRCTN35338757 |
| DOI | 10.1186/ISRCTN35338757 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Advantages and disadvantages of postmenopausal hormone therapy: a preventive trial - the Estonian Postmenopausal Hormone Therapy trial |
| Scientific title | |
| Acronym | EPHT |
| Serial number at source | 308901 |
| Study hypothesis |
The Estonian Postmenopausal Hormone Therapy (EPHT) trial is a randomised controlled trial, having blind and non-blind groups. By carrying out this trial comparing combined continuous postmenopausal Hormone Therapy (HT) to placebo or no drugs we will study:
1. Health effects of HT on the risk of cancers, coronary heart disease, cardiovascular disease, bone fractures 2. Immediate and long-term effects on well-being and quality of life 3. Effects on the experience of the climacteric and aging and partner relationship 4. Effects on the use of health services 5. Placebo effect and trial effect by means of the design as well as its effect on recruitment, adherence and trial outcomes Outcome data have been collected by annual questionnaires to the women, from national health registers (cancer register, death register, sickness insurance), and patient records. The analysis is by intention to treat: the women could opt out from the randomised treatment, but they remain in the study until they die or are lost to follow-up. In terms of long-term effects we assume that PHT will increase the incidence of breast cancer and decrease fractures. In terms of other diseases, we have no hypothesis on the direction of the effect. We assume that PHT will have beneficial effects to those of women who have menopausal symptoms, but regarding the direction of the effect on symptoms and well being in older women we have no a priori hypothesis. The impact on different dimensions is likely to vary. The same is true for social effects. We assume that PHT will increase the use of health services and result in more gynaecological interventions, including hysterectomy. In terms of feasibility, the hypotheses are: 1. The non-blind arm will have better recruitment, fewer drop-outs, and will be cheaper 2. The blind trial will not be fully blind (women will guess the therapy because of drug effects), and will be less contaminated later in the trial, when PHT is likely to be more common in Estonia. Cost in the non-blind arm will be reduced both by anticipated fewer visits and less need for a thorough study of spotting and other bleeding. |
| Lay summary | |
| Ethics approval | Ethics approval received from local research ethics committee (Tallinna Meditsiinieetika komitee) on the 22nd January 1998 (Signed Pavel Bogovski, Chief of the Ethical Committee). |
| Study design | Randomised controlled trial |
| Countries of recruitment | Estonia |
| Disease/condition/study domain | Menopausal disorders |
| Participants - inclusion criteria |
1. Women aged 50 - 64 years
2. Last period at least 12 months before recruitment |
| Participants - 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 |
| Anticipated start date | 13/01/1999 |
| Anticipated end date | 30/04/2004 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 1823 |
| 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 an additional 2.5 mg of MPA), or matched placebo.
Non-blind group: Open label 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 an additional 2.5 mg of MPA. Control group: No intervention |
| Primary outcome measure(s) |
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 outcome measure(s) | No secondary outcome measures |
| Sources of funding |
1. National Research and Development Centre for Welfare and Health (STAKES) (Finland) (ref: 308901)
2. Academy of Finland (Finland) (refs: 48117, 201490) 3. Ministry of Education in Finland (Finland) |
| Trial website | http://groups.stakes.fi/THP/FI/hankkeet/kayEPHTtrial.htm |
| Publications |
Results in:
1. 2005 progress report on patient recruitment in http://www.ncbi.nlm.nih.gov/pubmed/15826311 2. 2005 progress report on treatment adherence in http://www.ncbi.nlm.nih.gov/pubmed/16055284 3. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16504428 4. 2006 results on cost effectiveness in http://www.ncbi.nlm.nih.gov/pubmed/16813745 5. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17355268 6. 2008 results on symptom reporting and quality of life in http://www.ncbi.nlm.nih.gov/pubmed/18366766 7. 2008 progress report in http://www.ncbi.nlm.nih.gov/pubmed/18366766 8. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19505307 Academic dissertations' at: 1. http://acta.uta.fi/pdf/951-44-6629-2.pdf 2. http://acta.uta.fi/pdf/978-951-44-7134-6.pdf |
| Contact name | Prof Elina Hemminki |
| Address | Lintulahdenkuja 4 |
| City/town | Helsinki |
| Zip/Postcode | 00530 |
| Country | Finland |
| Tel | +358 (0)9 3967 2307 |
| Fax | +358 (0)9 3967 2227 |
| Elina.Hemminki@stakes.fi | |
| Sponsor | National Research and Development Centre for Welfare and Health (STAKES) (Finland) |
| Address | Lintulahdenkuja 4 |
| City/town | Helsinki |
| Zip/Postcode | 00530 |
| Country | Finland |
| Tel | +358 (0)9 39 671 |
| Vappu.Taipale@stakes.fi | |
| Sponsor website: | http://www.stakes.fi/EN/index.htm |
| Date applied | 09/09/2004 |
| Last edited | 06/07/2009 |
| Date ISRCTN assigned | 15/10/2004 |
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