E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
PMDD (premenstrual dysphoric disorder) includes depressed mood and anxiety but occurs only during the late phase of the menstrual cycle. Major depression are more common in women and especially post partum and during the menopause. PCOS (polycystic ovary syndrome) include symptoms like hirsutism, amenorrhoea and obesity but depressive symptom also occur. Mental side effects from oral contraceptives are common. |
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MedDRA Classification |
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 investigate the sensitivity to allopregnanolone (a GABA-agonistic neurosteroid), in different phases of the menstrual cycle, in women with PMDD, depression, PCOS and oral contraceptives compared to healthy controls without homonal treatment. To measure subjective ratings of mood symtoms and alertness in the same groups of women. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Group 1: Women 18-40 years of age with PMDD. 2. Group 2: Women 18-40 years of age with depression. 3. Group 3: Women 18-40 years of age with PCOS and increased weight. 4. Group 4: Women 18-40 years of age with oral contraceptives. 5. Group 5: healthy women 18-40 years of age without hormonal treatment. 6. Written informed consent. |
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E.4 | Principal exclusion criteria |
1. Treatment with bensodiazepins or other psychotropic drugs. 2. Treatment with systemic glucocorticoids. 3. Group 1, 2, 3, 5: Hormonal treatment of any kind during the last six months. 4. Group 1: Psychiatric disease or PCOS. 5. Group2: PMDD or PCOS. 6. Group 3: Psychiatric disease or PMDD. 7. Group 4, 5: Psychiatric disease, PMDD or PCOS. 8. Ongoing severe somatic disease. 9. Obesity. 10. Alcohol or drug abuse. 11. Eye disease with compromise measurement of saccadic eye movements. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Changes in saccadic eye movement velocity compared to pre-treatment. Changes in subjective ratings of sedation and mood symptoms compared to pre-treatment. |
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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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Comparing groups of patients and controls. |
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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 | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Prospective case-control study |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
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 | 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
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |