E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Safety, efficacy and tolerability investigations of a hormonal contraceptive in healthy females aged 18-40 years. |
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E.1.1.1 | Medical condition in easily understood language |
Safety, efficacy and tolerability investigations of a hormonal contraceptive in healthy females aged 18-40 years. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Reproductive physiologi cal processes [G08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10073728 |
E.1.2 | Term | Hormonal contraception |
E.1.2 | System Organ Class | 100000004865 |
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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 |
- descriptive comparison of the effect of Test and Reference on bleeding pattern over 6 cycles of treatment - assessment of pregnancy rates under treatment with Test and Reference over 6 cycles of treatment - descriptive comparison of the effect of Test and Reference on haemostasis parameters over 6 cycles of treatment - descriptive characterisation of the safety (including local tolerability) of Test and Reference over 6 cycles of treatment
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E.2.2 | Secondary objectives of the trial |
- descriptive characterisation of the safety (including local tolerability) of Test and Reference over a total of 13 cycles of treatment (including 7 cycles of safety follow-up) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. sexually active, at risk for becoming pregnant and in a mutually monogamous relationship for at least 6 months at study entry 2. willing to rely on the IMPs as the primary method of contraception during study participation 3. age: ≥ 18 years and ≤ 40 years 4. body-mass index (BMI): ≥ 18.5 kg/m² and ≤ 32.0 kg/m² 5. good state of health, non-smoker, ex-smoker or moderate smoker (<10 cigarettes per day) for at least 3 months 6. known regular menstrual cycles from 21 to 35 days in length, with an intra-individual variation of ±3 days permitted within this range for at least 6 months 7. signed and dated informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in the clinical trial |
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E.4 | Principal exclusion criteria |
1. existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient 2. existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient 3. history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders 4. known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations 5. subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator 6. presence of clinical relevant hypertension judged by investigator 7. laboratory values out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator 8. having a partner who is known to be HIV-positive 9. presence or history of venous or arterial thrombosis (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction or prodromal conditions (e.g. angina pectoris, transient ischaemic attack)), cerebrovascular accident, inborn or acquired predisposition for venous or arterial thrombosis such as APC resistance, antithrombin-III-deficiency, protein-C or –S-deficiency, hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant, known Leiden factor V mutation 10. plans for surgery requiring prolonged immobilization 11. any presence or history of malignancies, personal history of benign breast diseases, family history of breast cancer 12. abnormal PAP smear at screening examination 13. severe dyslipoproteinaemia (LDL > 130 mg/dl and HDL < 35 mg/dl or LDL/HDL ratio > 5) 14. diabetes mellitus with end-organ involvement or >20 years’ duration 15. history or signs of migraine with focal neurological symptoms 16. history of ectopic pregnancies 17. existing cervicitis or bleeding cervical erosions 18. abnormal uterine bleeding of unknown origin within past 6 months 19. amenorrhea with unknown cause within past 6 months 20. prolapse of uterine cervix, cystocele and/or rectocele 21. severe or chronic constipation 22. sterilized partner Lack of suitability for the clinical trial 23. acute or chronic diseases which may interfere with the aims of the clinical trial 24. history of or current drug or alcohol dependence 25. participation in a clinical trial during the last 2 months prior to individual enrolment of the subject 26. repeated intake of any medication during the last 2 weeks prior to individual start of treatment cycle of the subject which might interfere with absorption, efficacy or safety of the IMPs 27. repeated intake of food or beverages containing St. John's Wort after screening examination and prior to randomisation 28. use of vitamin K within two weeks prior to individual start of treatment cycle of the subject and regular use of nonsteroidal anti-inflammatory drugs (NSAIDS) by the subject 29. regular use of anticoagulants or inhibitors of platelet aggregation within 1 month prior to individual start of treatment cycle of the subject 30. use of any intramuscularly administered sexual hormone preparations within 2 months (intramuscularly administered depot preparations used once per month) or 6 months (intramuscularly administered depot preparations used once per 3 months) as well as hormonal intrauterine systems or subdermally administered preparations (e.g. single-rod subdermal contraceptive implant) within 2 months prior to individual start of treatment cycle of the subject 31. positive pregnancy test at screening examination 32. known or suspected pregnancy or lactating or planning pregnancy within 12 months of study entry 33. fewer than 3 menstrual cycles since delivery, abortion, or lactation before start of treatment Administrative reasons 34. subjects suspected or known not to follow instructions 35. subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial 36. subject who is a family member or work associate (secretary, nurse, technician, etc.) of the investigator 37. subject who has forfeited his freedom by administrative or legal award, or who is under guardianship |
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E.5 End points |
E.5.1 | Primary end point(s) |
bleeding pattern assessment of pregnancy rates haemostasis parameter safety (including local tolerability) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
bleeding pattern, pregnancy rates, haemostasis after 6 cycles, safety (AEs, local tolerability) after 6 cycles |
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E.5.2 | Secondary end point(s) |
safety (AEs, local tolerability) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
safety (AEs, local tolerability) after 13 cycles |
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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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | 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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 20 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 35 |
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 | No |
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 |
Bulgaria |
Moldova, Republic of |
Poland |
Russian Federation |
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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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End of the clinical trial is defined as the day of shipment of the last Case Report Form (CRF) to the company responsible for clinical biometrics. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |