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Hormonal Replacement Therapy and Small Artery Function (HRT)

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ClinicalTrials.gov Identifier: NCT00564031
Recruitment Status : Completed
First Posted : November 27, 2007
Last Update Posted : November 27, 2007
Information provided by:
Karolinska University Hospital

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

Condition or disease Intervention/treatment Phase
Menopause Drug: Femanest Drug: gestapuran Drug: placebo Drug: Femanest plus Gestapuran Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Hormonal Replacement Therapy and Small Artery Function
Study Start Date : January 2003
Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1 Drug: placebo
Experimental: 2 Drug: Femanest
Experimental: 3 Drug: gestapuran
Experimental: 4 Drug: Femanest plus Gestapuran
combined daily

Primary Outcome Measures :
  1. endothelium-dependent dilatation [ Time Frame: 3 month ]

Secondary Outcome Measures :
  1. pressure-induced tone and vascular morphology [ Time Frame: 3 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00564031

Karolinska University hospital-huddinge
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska University Hospital
Principal Investigator: Karolina Kublickiene, MD PhD Karolinska University Hospital

ClinicalTrials.gov Identifier: NCT00564031     History of Changes
Other Study ID Numbers: 166/99
First Posted: November 27, 2007    Key Record Dates
Last Update Posted: November 27, 2007
Last Verified: November 2007

Keywords provided by Karolinska University Hospital:
hormone replacement therapy; endothelial function;

Additional relevant MeSH terms:
Medroxyprogesterone Acetate
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral