E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
prevention of in treatment pregnancies |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10010808 |
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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 |
Primary objective To assess contraceptive efficacy, vaginal bleeding patterns cycle control , general safety and acceptability of the NOMAC-E2 COC in a large group of women aged 18-50 years. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives To evaluate the effects of the NOMAC-E2 COC on satisfaction and health related quality of life, libido, acne, menstrual symptoms, and body weight; To explore the aforementioned characteristics of the NOMAC- E2 COC in comparison with the DRSP-EE COC. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Sexually active women, at risk for pregnancy and not planning to use condoms; Women in need for contraception and willing to use an Oral Contraceptive OC for 12 months 13 cycles ; At least 18 but not older than 50 years of age at the time of screening; Body mass index 8805;17 and 8804;35; Good physical and mental health; Willing to give informed consent in writing. |
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E.4 | Principal exclusion criteria |
Contraindications for contraceptive steroids - Presence or a history of venous or arterial thrombotic/thromboembolic events e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction or of a cerebrovascular accident; - Presence or history of prodromi of a thrombosis e.g. transient ischaemic attack, angina pectoris ; - History of migraine with focal neurological symptoms; - Diabetes mellitus with vascular involvement; - The presence of a severe or multiple risk factor s for venous or arterial thrombosis to be judged by the sub -investigator . - Pancreatitis or a history thereof if associated with severe hypertriglyceridaemia; - Presence or history of severe hepatic disease as long as liver function values have not returned to normal; - Presence or history of liver tumors benign or malignant ; - Known or suspected sex steroid-influenced malignancies e.g. of the genital organs or the breasts ; - Undiagnosed vaginal bleeding; - Known or suspected pregnancy; - Hypersensitivity to the active substances or to any of the excipients of the investigational product. An abnormal cervical smear i.e. dysplasia, cervical intraepithelial neoplasia CIN , Squamous Intraepithelial Lesion SIL , carcinoma in situ, invasive carcinoma at screening; Clinically relevant abnormal laboratory result at screening as judged by the investigator; Use of an injectable hormonal method of contraception; within 6 months of an injection with a 3-month duration, within 4 months of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration; Before spontaneous menstruation has occurred following a delivery or abortion; Breastfeeding or within 2 months after stopping breastfeeding prior to the start of trial medication; Present use or use during 2 months prior to the start of the trial medication of the following drugs phenytoin, barbiturates, primidone, carbamazapine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex steroids other than pre- and post treatment contraceptive method and herbal remedies containing Hypericum perforatum St John s Wort ; Administration of any other investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Contraceptive efficacy prevention of in treatment pregnancies Pearl Index |
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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 | Yes |
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 | Information not present in EudraCT |
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 | Information not present in EudraCT |
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.8.3 |
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.8.6 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 | Information not present in EudraCT |
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 |
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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
| |
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 | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |