E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Age/menopause related changes in the artery wall composition after menopause |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003601 |
E.1.2 | Term | Atherosclerosis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051775 |
E.1.2 | Term | Postmenopause |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020388 |
E.1.2 | Term | Hormone replacement therapy |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
Changes in body mass index (height and weight measured), body fat distribution (waist & circumference and skin folds). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Effects of registered compound |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |