Advantages and disadvantages of postmenopausal hormone therapy: a preventive trial - the Estonian Postmenopausal Hormone Therapy trial
| ISRCTN | ISRCTN35338757 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35338757 |
| Secondary identifying numbers | 308901 |
- Submission date
- 09/09/2004
- Registration date
- 15/10/2004
- Last edited
- 01/11/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Elina Hemminki
Scientific
Scientific
Lintulahdenkuja 4
Helsinki
00530
Finland
| Phone | +358 (0)9 3967 2307 |
|---|---|
| Elina.Hemminki@stakes.fi |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Advantages and disadvantages of postmenopausal hormone therapy: a preventive trial - the Estonian Postmenopausal Hormone Therapy trial |
| Study acronym | EPHT |
| 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. |
| Ethics approval(s) | Local research ethics committee (Tallinna Meditsiinieetika komitee), 22/01/1998 |
| Condition | Menopausal disorders |
| Intervention | 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 |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Oestrogen, medroxyprogesterone acetate |
| Primary outcome measure | 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 measures | No secondary outcome measures |
| Overall study start date | 13/01/1999 |
| Overall study end date | 30/04/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 1823 |
| Participant inclusion criteria | 1. Women aged 50 - 64 years 2. Last period at least 12 months before recruitment |
| Participant 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 |
| Recruitment start date | 13/01/1999 |
| Recruitment end date | 30/04/2004 |
Locations
Countries of recruitment
- Estonia
- Finland
Study participating centre
Lintulahdenkuja 4
Helsinki
00530
Finland
00530
Finland
Sponsor information
National Research and Development Centre for Welfare and Health (STAKES) (Finland)
Research organisation
Research organisation
Lintulahdenkuja 4
Helsinki
00530
Finland
| Phone | +358 (0)9 39 671 |
|---|---|
| Vappu.Taipale@stakes.fi | |
| Website | http://www.stakes.fi/EN/index.htm |
"ROR" |
https://ror.org/03tf0c761 |
Funders
Funder type
Research organisation
National Research and Development Centre for Welfare and Health (STAKES) (Finland) (ref: 308901)
No information available
Academy of Finland (Finland) (refs: 48117, 201490)
Government organisation / Universities (academic only)
Government organisation / Universities (academic only)
- Alternative name(s)
- Suomen Akatemia, Finlands Akademi, Academy of Finland, AKA
- Location
- Finland
Ministry of Education in Finland (Finland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | progress report on patient recruitment | 12/04/2005 | Yes | No | |
| Other publications | progress report on treatment adherence | 01/11/2005 | Yes | No | |
| Results article | results on cost effectiveness | 01/07/2006 | Yes | No | |
| Results article | results | 20/09/2006 | Yes | No | |
| Results article | results | 01/05/2007 | Yes | No | |
| Other publications | progress report | 26/03/2008 | Yes | No | |
| Results article | results on symptom reporting and quality of life | 26/03/2008 | Yes | No | |
| Results article | results | 08/06/2009 | Yes | No | |
| Results article | effect of characteristics of women on attendance results | 18/10/2016 | Yes | No |
Editorial Notes
01/11/2016: Publication reference added.
