Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised open label controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Oestradiol, norethisterone, testosterone
Primary outcome measures
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 trial start date
01/02/1995
Overall trial end date
13/03/2000
Reason abandoned
Eligibility
Participant inclusion criteria
Women aged 50 - 65 years from lists in general practices local to the Charing Cross Hospital Lipid Clinic in West London.
Participant type
Patient
Age group
Other
Gender
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
Participant exclusion criteria
Women with liver, renal or endocrine abnormalities were excluded, as were those on lipid altering medication.
Recruitment start date
01/02/1995
Recruitment end date
13/03/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cardiovascular Medicine
London
W6 8RF
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Cardiovascular Disease and Stroke National Research and Development Programme (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2000 results in http://www.ncbi.nlm.nih.gov/pubmed/11120722
Publication citations
-
Results
Seed M, Sands RH, McLaren M, Kirk G, Darko D, The effect of hormone replacement therapy and route of administration on selected cardiovascular risk factors in post-menopausal women., Fam Pract, 2000, 17, 6, 497-507.