ow-Dose Hormone Therapy Initiated early after Menopause and Changes in Artery Wall Composition (AWC), as Assesssed by High-Frequency Ultrasound. - AWC LowE

• Conditions: Age/menopause related changes in the artery wall composition after menopause; MedDRA version: 9.1Level: LLTClassification code 10003601Term: Atherosclerosis; MedDRA version: 9.1Level: LLTClassification code 10051775Term: Postmenopause; MedDRA version: 9.1Level: LLTClassification code 10020388Term: Hormone replacement therapy

• Registration Number: EUCTR2007-005109-23-SE
• Lead Sponsor: ppsala University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Postmenopausal women, i.e. > 1 year after last menstrual period
Age 50 - 59 years; Having an intact uterus; HRT naive or more than 3 yrs since last use of medium potent HRT (low-dose vaginal regimens allowed); Endometrial thickness <=5mm at inclusion. Normal mammogram within the last 12 months.
Signed informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Current or previous use of HT within the last 3 years; current use of lipid-lowering agents, oral corticosteroids for more than one month within the last 3 years;Body Mass Index (BMI) >35 kg/m2;
Known or suspected past or present history of breast cancer;
Known, suspected or past estrogen dependent neoplasia, e.g. endometrial cancer;
Known, present or past history of coronary heart disease.

Contraindication for HT: undiagnosed genital bleeding, untreated endometrial hyperplasia, previous idiopathic or current venous thromboembolism (deep venous thrombosis, pulmonary embolism), active or recent arterial thromboembolic disease ) e.g. angina, myocardial infarction), acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal, known hypersensitivity to the active substances or to any of the excipients, porphyria
Hypertension: >150/95
Untreated Thyroid disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified