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Completed

NCT Number: NCT00564031

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

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Key information

Conditions

Menopause

Age range

50 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Karolinska University hospital-huddinge

Stockholm, 14186, Sweden

About this 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Femanest

Drug

2mg/day

gestapuran

Drug

5mg/day

Placebo

Drug

daily

Femanest plus Gestapuran

Drug

combined daily

Primary outcomes

  1. endothelium-dependent dilatation

    Time frame: 3 month

Secondary outcomes

  1. pressure-induced tone and vascular morphology

    Time frame: 3 month

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Acronym: HRT

Important dates

Study start
2003
Study completion
2004
First posted
Nov 27, 2007
Registry last updated
Nov 27, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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