Official Title: “Hormonal Replacement Therapy and Small Artery Function”

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

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Femanest
  • 2mg/day
• Drug: gestapuran
  • 5mg/day
• Drug: placebo
  • daily
• Drug: Femanest plus Gestapuran
  • combined daily

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
• Experimental: 2
• Experimental: 3
• Experimental: 4

Primary Measures

• endothelium-dependent dilatation
  • Time Frame: 3 month
    

Secondary Measures

• pressure-induced tone and vascular morphology
  • Time Frame: 3 month
    

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Karolinska University Hospital

Overall Clinical Trial Officials and Contacts

Karolina Kublickiene, MD PhD Principal Investigator Karolinska University Hospital  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00564031

Study ID Number: 166/99

ClinicalTrials.gov Identifier: NCT00564031

Health Authority: Sweden: Regional Ethical Review Board