We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hormonal Replacement Therapy and Small Artery Function (HRT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00564031
First Posted: November 27, 2007
Last Update Posted: November 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Karolinska University Hospital
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Hormonal Replacement Therapy and Small Artery Function

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 60 Years   (Adult)
Sexes 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
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


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

ClinicalTrials.gov Identifier: NCT00564031     History of Changes
Other Study ID Numbers: 166/99
First Submitted: November 26, 2007
First Posted: November 27, 2007
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
Medroxyprogesterone
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