Hormonal Replacement Therapy and Small Artery Function
Phase 3
Completed
- Conditions
- Menopause
- Interventions
- Drug: placeboDrug: FemanestDrug: gestapuranDrug: Femanest plus Gestapuran
- Registration Number
- NCT00564031
- Lead Sponsor
- Karolinska University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 66
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 placebo - 2 Femanest - 3 gestapuran - 4 Femanest plus Gestapuran -
- Primary Outcome Measures
Name Time Method endothelium-dependent dilatation 3 month
- Secondary Outcome Measures
Name Time Method pressure-induced tone and vascular morphology 3 month
Trial Locations
- Locations (1)
Karolinska University hospital-huddinge
🇸🇪Stockholm, Sweden