E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Body processes [G] - Reproductive physiologi cal processes [G08] |
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 |
Primary Objectives: To assess the contraceptive efficacy and safety of once a week mifepristone 50 mg.
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E.2.2 | Secondary objectives of the trial |
Secondary Objectives: To determine the side-effects and acceptability of once a week mifepristone 50 mg.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
female, 18-35 years; no desire to become pregnant within the next 13 months; have a normal menstrual cycle of 25-35 days cycles which differ by no more than 3 days with less than 7 days of bleeding; at least one normal menstrual cycle after miscarriage or abortion and no abnormal blood loss; be willing to engage in at least three acts of penis-in-vagina sexual intercourse per month; be willing to use the study drug as the only method of contraception |
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E.4 | Principal exclusion criteria |
known infertility or subfertility; current pregnancy, within 3 months of delivery; lactation; abnormal cervical smear or within year before; history of ectopic pregnancy; any previous or current malignancy including breast cancer; abnormal liver enzymes; irregularities in endometrium; retained products of conception after miscarriage or abortion; signs of endometritis; known allergic reactions to mifepristone; using high doses of corticosteroids or any drugs that may interact with mifepristone - these include hydantoins (e.g. phenytoin), barbiturates (e.g. phenobarbital), primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, rifabutin, felbamate, ritonavir, nelfinavir, griseofulvin and products containing St. John's wort (Hypericum perforatum); treatment with another investigational drug (until next normal period after stopping other trial); unable to comply with the trial protocol |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Endpoints: 1. Occurrence of pregnancy during treatment caused by method failure. 2. Proportion of women with endometrium thickness>15 mm, endometrium with irregular cystic appearance on US at baseline months 3, 6, 9, 13 and time to normalisation after end of treatment. 3. Proportion of women with ALAT, ASAT and bilirubin elevation three times above normal at baseline, months 3, 6, 9, 13 and time to normalisation after end of treatment. 4. Proportion of women with adverse event / serious adverse event
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
when 33% and 66% of participants completed the study
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E.5.2 | Secondary end point(s) |
Secondary endpoints: 1. Occurrence of pregnancy during treatment caused by user failure. 2. Proportion of women with blood hormone levels abnormalities. 3. Proportion of women with anovulatory cycles. 4. Proportion of women with endometrial changes (PAEC) confirmed by biopsy at baseline, months 3, 6, 9, 13 and time to normalisation after end of treatment. 5. Proportion of women with normal haemoglobin value at baseline, months 3, 6, 9, 13. 6. Mean value of quality of life questionnaire (EQ-5D-5L) at baseline, months 3, 6, 9, 13. 7. Proportion of women who uses antidepressants at baseline and during the study. 8. Proportion of women with dysmenorrhea (diary continued measurement) during the study. 9. Proportion of women with acne occurrence (diary continued reporting) during the study. 10. Proportion of women with side-effects (headache, nausea, breast pain, dry eyes) (diary continued reporting) during the study. 11. Mean weight changes at 3 months, 6 months, 9 months, 13 months compared to baseline. 12. Proportion of women with vaginal bleeding (diary continued measurement) 13. Libido: mean value of Female Sexual Function Index (FSFI) at baseline, months 3, 6, 9, 13. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
when 33% and 66% of participants completed the study |
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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) | 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 | No |
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 | No |
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 |
Will this trial be conducted at a single site globally?
| Yes |
E.8.4 | Will this trial be conducted at multiple sites globally? | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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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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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.8.9.2 | In all countries concerned by the trial years | 5 |