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Hormonal Replacement Therapy and Small Artery Function

NCT ID: NCT00564031

Last Updated: 2007-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2004-08-31

Brief Summary

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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 disease

Detailed Description

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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.

Conditions

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Menopause

Keywords

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hormone replacement therapy; endothelial function;

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

daily

2

Group Type EXPERIMENTAL

Femanest

Intervention Type DRUG

2mg/day

3

Group Type EXPERIMENTAL

gestapuran

Intervention Type DRUG

5mg/day

4

Group Type EXPERIMENTAL

Femanest plus Gestapuran

Intervention Type DRUG

combined daily

Interventions

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Femanest

2mg/day

Intervention Type DRUG

gestapuran

5mg/day

Intervention Type DRUG

placebo

daily

Intervention Type DRUG

Femanest plus Gestapuran

combined daily

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Karolina Kublickiene, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

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Karolinska University hospital-huddinge

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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166/99

Identifier Type: -

Identifier Source: secondary_id

166/99

Identifier Type: -

Identifier Source: org_study_id