Menopause
Conditions
Keywords
hormone replacement therapy; endothelial function;
Brief summary
Endothelial dysfunction in resistance arteries in women after the menopause is important for the development of high blood pressure and cardiovascular disease
Detailed description
We aim to study the effects of different hormone replacement therapies (HRT) on the function and morphology of resistance arteries, and to look for their mechanistic basis. We expect that HRT with estrogens or in combination with MPA may benefit the function of resistance arteries and may preserve the morphological integrity of endothelial cells by regulatory actions on the cytoskeleton.
Interventions
DRUGFemanest
2mg/day
DRUGgestapuran
5mg/day
DRUGplacebo
daily
DRUGFemanest plus Gestapuran
combined daily
Sponsors
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* All women had been amenorrheic for at least 1.5 year. * Menopausal status was confirmed by a serum concentration of follicular- stimulating hormone (FSH \> 34 IU/ml) and estradiol (E2 \<50 pmol/l).
Exclusion criteria
* Cigarette smokers and women with: * Hypertension * Diabetes mellitus * Clinical manifestations of arteriosclerosis (coronary heart disease, peripheral artery disease, or cerebrovascular disease) * Venous thromboembolic disease * Liver disorders * Unexplained vaginal bleeding; and * Personal or family history of breast cancer were excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| endothelium-dependent dilatation | 3 month |
Secondary
| Measure | Time frame |
|---|---|
| pressure-induced tone and vascular morphology | 3 month |
Countries
Sweden
Outcome results
None listed