Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
21/12/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mary Seed

ORCID ID

Contact details

Cardiovascular Medicine
5th Floor
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
+44 (0)20 8846 7901

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes