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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-005109-23-SE

Enrollment

100

Registered

2009-06-30

Start date

2009-08-05

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Eviana (0.5mg E2 / 0.1 mg NETA) Pharmaceutical Form: Tablet Concentration unit: mg milligram(s) Concentration type: equal Pharmaceutical form of the placebo: Tablet Route of administration

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Effects of low dose hormone replacement therapy (HRT) on the age/menopause-related changes in the artery wall composition (common carotid artery): Intima thickness, media thickness and I/M thickness ratio. Results will be compared with placebo-treated women. Changes will be related to age at start of HRT and baseline serum hormone levels.;Secondary Objective: Changes in body mass index (height and weight measured), body fat distribution (waist & circumference and skin folds).;Primary end point(s): Changes within and between study groups with regard to changes in carotid artery intima thickness, media thickness and I/M thickness ratio, as assessed by ultrasonography.	—

Measure

Time frame

Main Objective: Effects of low dose hormone replacement therapy (HRT) on the age/menopause-related changes in the artery wall composition (common carotid artery): Intima thickness, media thickness and I/M thickness ratio. Results will be compared with placebo-treated women. Changes will be related to age at start of HRT and baseline serum hormone levels.;Secondary Objective: Changes in body mass index (height and weight measured), body fat distribution (waist & circumference and skin folds).;Primary end point(s): Changes within and between study groups with regard to changes in carotid artery intima thickness, media thickness and I/M thickness ratio, as assessed by ultrasonography.

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026