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Hormonal Replacement Therapy and Small Artery Function (HRT)

This study has been completed.
Sponsor:
Information provided by:
Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT00564031
First received: November 26, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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


Condition Intervention Phase
Menopause
 Drug: Femanest
Drug: gestapuran
Drug: placebo
Drug: Femanest plus Gestapuran
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Hormonal Replacement Therapy and Small Artery Function

Resource links provided by NLM:

MedlinePlus related topics: Menopause
U.S. FDA Resources

Further study details as provided by Karolinska University Hospital:

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

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

Enrollment: 66
Study Start Date: January 2003
Study Completion Date: August 2004
Arms Assigned Interventions
Placebo Comparator: 1 Drug: placebo
daily
Experimental: 2 Drug: Femanest
2mg/day
Experimental: 3 Drug: gestapuran
5mg/day
Experimental: 4 Drug: Femanest plus Gestapuran
combined daily

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.

  Eligibility

Ages Eligible for Study:   50 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564031

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

No publications provided

ClinicalTrials.gov Identifier: NCT00564031     History of Changes
Other Study ID Numbers: 166/99, 166/99
Study First Received: November 26, 2007
Last Updated: November 26, 2007
Health Authority: Sweden: Regional Ethical Review Board

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

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

ClinicalTrials.gov processed this record on June 17, 2013