Hormonal Replacement Therapy and Small Artery Function - Full Text View

Sponsored by:	Karolinska University Hospital
Information provided by:	Karolinska University Hospital
ClinicalTrials.gov Identifier:	NCT00564031

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 III

MedlinePlus related topics: Menopause

Drug Information available for: Medroxyprogesterone Medroxyprogesterone 17-acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Hormonal Replacement Therapy and Small Artery Function

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
1: Placebo Comparator	Drug: placebo daily
2: Experimental	Drug: Femanest 2mg/day
3: Experimental	Drug: gestapuran 5mg/day
4: Experimental	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

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

Keywords provided by Karolinska University Hospital:

hormone replacement therapy; endothelial function;

Study placed in the following topic categories:

Medroxyprogesterone 17-Acetate
Medroxyprogesterone
Menopause

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents
Therapeutic Uses
Physiological Effects of Drugs
Contraceptives, Oral

Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Reproductive Control Agents
Contraceptive Agents, Male
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009