E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Contraception or menorrhagia |
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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 | 10010808 |
E.1.2 | Term | Contraception |
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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 |
The primary objective of the study is to assess the bleeding profile during the first year of use of the second consecutive MIRENA. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are assessment of the removal of the first MIRENA (by investigator and patient) and the insertion of the second MIRENA (by investigator and patient), continuation rate, pregnancy rate, menstrual comfort and user satisfaction during the first year of use. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Signed informed consent. Woman of 23 to 45 years of age (inclusive) who is currently using MIRENA for contraception or menorrhagia, her duration use is between 4 years 3 months and 4 years 9 months and she is willing to continue with the method. Normal size uterus at insertion, corresponding to sound measure of 6-10 cm. Clinically normal cervical smear result within 12 preceding months or at screening. Clinically normal breast examination findings. For patients ≥ 40 years at screening, a clinically normal mammography result within 12 preceding months or at screening is required. Willingness and ability to attend the clinic for scheduled visits and to comply with the study procedures. Additional inclusion criteria for misoprostol subset: Willingness to accept pretreatment as allocated through randomization.
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E.4 | Principal exclusion criteria |
Menopausal symptoms impairing patient's quality of life or current estrogen therapy for menopausal symptoms. Known or suspected pregnancy. Any distortion of the uterine cavity, including congenital or acquired uterine anomalies and fibroids distorting the uterine cavity. Current or recurrent pelvic inflammatory disease. Abnormal uterine bleeding of unknown origin. Acute cervicitis or vaginitis not responding to treatment. History of, diagnosed or suspected genital or other malignancy (excluding treated squamous cell carcinoma of the skin), and untreated cervical dysplasia. Any active acute liver disease or liver tumor.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable in the study is the assessment of occurrence and intensity of bleeding during the last 3 months of the first MIRENA and the first year of the second MIRENA use.
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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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |