Hormonal Replacement Therapy and Small Artery Function

Menopause Clinical Trial

— HRT  

Official title:

Hormonal Replacement Therapy and Small Artery Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00564031
• Other study ID #: 166/99
• Secondary ID: 166/99
• Status: Completed
• Phase: Phase 3
• First received: November 26, 2007
• Last updated: November 26, 2007
• Start date: January 2003
• Est. completion date: August 2004

Study information

• Verified date: November 2007
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Menopause

Intervention

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

Locations

Country	Name	City	State
Sweden	Karolinska University hospital-huddinge	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endothelium-dependent dilatation		3 month
Secondary	pressure-induced tone and vascular morphology		3 month