E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postmenopausal symptoms (hot flashes) |
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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 | 10050903 |
E.1.2 | Term | Postmenopausal symptoms |
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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 assess the preliminary efficacy of the OphenaTM 60 mg in the treatment of vasomotor symptoms associated with the menopause. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The subject is a woman 40 to 70 years old at the time of randomization. The subject is postmenopausal. Postmenopausal is defined as • at least 12 months since the last spontaneous menstrual bleeding and serum FSH levels > 40 IU/L and estradiol ≤ 0.20 nmol/mL or • hysterectomy with intact ovaries and serum FSH levels > 40 IU/L and estradiol ≤ 0.20 nmol/L or • at least 6 weeks post- surgical bilateral oophorectomy. The subject has at least 7 moderate, severe, or very severe hot flashes per day or 50 per week recorded for seven consecutive days. This information will be confirmed on the screening diary. |
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E.4 | Principal exclusion criteria |
Subject has taken certain hormonal medications (listed in protocol). Subject has clinically significant abnormal gynecological findings other than vaginal atrophy at screening. Subject has taken a selective estrogen receptor modulator (SERM) within 60 days prior to screening Subject has clinically relevant abnormal findings in any safety laboratory tests. Subject has current or history of thromboembolic or blood coagulation disorder. Subject has current or history of cerebrovascular incident |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in Frequency of Vasomotor Symptoms -- The total number of hot flashes per week will be determined from the HFD for the screening week (baseline measurement) and for each of the six weeks of treatment. The % change from baseline to Week 6 (End-of-Therapy) in total number of hot flashes per week will be a primary efficacy parameter.
Change in Severity of Vasomotor Symptoms -- A hot flash severity score will be calculated from each HFD for the screening week (baseline measurement) and for each of the six weeks of treatment by multiplying the number of hot flashes in each severity category (mild, moderate, severe, very severe) by the category code (1, 2, 3, 4, respectively) and summing the results. |
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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 | 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 | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 14 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |