E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10058825 |
E.1.2 | Term | Menopausal disorder |
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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 |
To show superiority of a 12 week treatment with Zavital over placebo in reduction of frequency of hot flushes in post-menopausal women |
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E.2.2 | Secondary objectives of the trial |
61485;To evaluate the efficacy of a 12 week treatment with Zavital in reduction of intensity of vasomotor symptoms 61485;To evaluate the efficacy of a 12 week treatment with Zavital in reduction of all climacteric symptoms Greene Climacteric Scale 61485;To evaluate the safety of a 12-week treatment with Zavital in terms of incidence of adverse events, vital signs and laboratory evaluations. 61485;To evaluate the global efficacy and tolerability of a 12-week treatment with Zavital |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
61485;Post menopausal women aged between 40-65, with at least 6 months since the last menstrual period or 6 weeks from bilateral oophorectomy, and the serum levels of FSH 8805; 30 IU/L and estradiol 8804; 40 pg/ml at baseline. 61485;Patients with a minimum average of 5 moderate to severe hot flushes including night sweats in 24h during the last 7 days on patient s diary before randomization |
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E.4 | Principal exclusion criteria |
61485;Concomitant therapies such as Hormone Replacement Therapy HRT and any other hormone therapies estrogens, progesterone, androgens in the last 3 months before the inclusion into the study; other agents for the treatment of hot flushes such as megestrol acetate, clonidine, vitamin E, phenobarbital, ergotamine tartrate, antidepressant agents and patients habitually taking 4 days a week products containing isoflavones in the last month before screening visit. 61485;Patients with severe hepatic failure AST and ALT twice the upper limit , renal failure creatinine 1.5 mg/dl , diabetes mellitus type I or uncontrolled type II , uncontrolled dysthyroidism, manifest heart failure condition NYHA II-IV , severe neurologic diseases, as well as patients with hypersensitivity to soy products. 61485;Patients with previous breast cancer in the last 5 years or suspected breast nodules at physical examination |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is the change from baseline in the mean daily frequency of moderate and severe hot flushes during the last 7 days on patient s diary prior to visit of mid-treatment 6th week , first of all, and secondly at the end-of treatment 12th week |
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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 | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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 | No |
E.7.1.3.1 | Other trial type description | |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |