Cardiovascular risk factors in post menopausal woman: The effect of mode of delivery of hormone replacement therapy (HRT)
| ISRCTN | ISRCTN22651289 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22651289 |
| Secondary identifying numbers | N/A |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 21/12/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mary Seed
Scientific
Scientific
Cardiovascular Medicine
5th Floor
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
| Phone | +44 (0)20 8846 7901 |
|---|
Study information
| Study design | Randomised open label controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To establish differences, if any, in alteration in cardiovascular risk factors with HRT in post menopausal women according to route of administration of HRT, oral, transdermal and implant, using first oestrogen alone then oestrogen plus norethisterone, or testosterone for implant. There is increasing use of HRT by post menopausal women. Observational epidemiological studies in the United States but no randomised controlled trials of HRT have been carried out in the primary practice setting. Previous studies of cardiovascular risk factors have shown a variety of responses according to type of progestagen and oral or topical administration. None has examined the effect of route using identical progestagen. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Hypertension, menstrual disorders and hormone replacement therapy (HRT) |
| Intervention | Menopausal status was confirmed and women were randomised to one of three treatment groups or acted as controls. The treatment regimes were two oral groups, with cyclical or continuous progestagen, and one transdermal regime with cyclical progestagen. The group who had had a hysterectomy received HRT by implant. Each regime lasted six months: for the first 3 months, oestradiol unopposed was given by each route; for the second three months, norethisterone was added as the progestagen, orally and transdermally as appropriate. Measurements: Blood samples 1. fasting glucose 2. insulin 3. total cholesterol 4. high-density lipoprotein (HDL) cholesterol 5. low-density lipoprotein (LDL) cholesterol and triglycerides 6. lipoprotein (a) 7. follicular stimulating hormone 8. lutenising hormone 9. oestradiol 10. factor VII 11. fibrinogen 12. plasmin antiplasmin 13. thrombin anti thrombin 14. Von willebrand factors 15. E-selectin |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Oestradiol, norethisterone, testosterone |
| Primary outcome measure | 1. Response to HRT 2. Anthropometric measurements 3. Cardiovascular Risk Factors 4. Blood pressure 5. Lipoproteins 6. Glucose and insulin 7. Clotting variables 8. Arterial wall factors |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/02/1995 |
| Completion date | 13/03/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Female |
| Target number of participants | 260 recruited (intervention group: 160, control group: 100); 161 completed (intervention group: 78, control group: 83); seperate implant group 34 |
| Key inclusion criteria | Women aged 50 - 65 years from lists in general practices local to the Charing Cross Hospital Lipid Clinic in West London. |
| Key exclusion criteria | Women with liver, renal or endocrine abnormalities were excluded, as were those on lipid altering medication. |
| Date of first enrolment | 01/02/1995 |
| Date of final enrolment | 13/03/2000 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cardiovascular Medicine
London
W6 8RF
United Kingdom
W6 8RF
United Kingdom
Sponsor information
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
NHS Cardiovascular Disease and Stroke National Research and Development Programme (UK)
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? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2000 | Yes | No |
