Hormonal Replacement Therapy and Small Artery Function (HRT)

Karolinska University Hospital

Status and phase

Completed

Phase 3

Conditions

Menopause

Treatments

Drug: placebo

Drug: Femanest plus Gestapuran

Drug: gestapuran

Drug: Femanest

Study type

Interventional

Funder types

Other

Identifiers

NCT00564031

166/99

Details and patient eligibility

About

Endothelial dysfunction in resistance arteries in women after the menopause is important for the development of high blood pressure and cardiovascular disease

Full 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.

Enrollment

66 patients

Sex

Female

Ages

50 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.