Hormonal Replacement Therapy and Small Artery Function

Verified by: Karolinska University Hospital, November 2007
First Received: November 26, 2007 | Last Updated: November 26, 2007 | Phase: Phase 3 | Start Date: January 2003
Overall Status: Completed | Estimated Enrollment: 66
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Endothelial dysfunction in resistance arteries in women after the menopause is important for the development of high blood pressure and cardiovascular...

Brief Summary

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

Detailed Clinical Trial 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.

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

Outcome Measures for this Clinical Trial

Primary Measures

  • endothelium-dependent dilatation
    • Time Frame: 3 month

Secondary Measures

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Karolinska University Hospital Other

Overall Clinical Trial Officials and Contacts

Karolina Kublickiene, MD PhD Principal Investigator Karolinska University Hospital  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00564031