E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hormonal oral contraception in healthy women |
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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 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 |
- To evaluate the effect 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 | No |
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 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 ≥17 and ≤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). e.g. increasing age; smoking (with heavier smoking and increasing age the risk further increases, especially in women over 35 years of age); a positive family history (i.e. venous or arterial thromboembolism ever in a sibling or parent at a relatively early age); obesity (body mass index over 30 kg/m2); dyslipoproteinaemia; hypertension, migraine, valvular heart disease, atrial fibrillation; prolonged immobilization, major surgery any surgery to the legs, or major trauma until two weeks after full remobilization; systemic lupus erythematosus; haemolytic uraemic syndrome; chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis); sickle cell disease; • Severe dyslipoproteinemia • Severe hypertension • Hereditary or acquired predisposition for venous or arterial thrombosis, such as APC resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant); • 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. - In accordance with the SmPC/Package Insert of DRSP-EE, additional contraindications related to the antimineralocorticoid activity of drospirenone (conditions that predipose to hyperkalemia): • Renal insufficiency; • Hepatic dysfunction; • Adrenal insufficiency. - An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia (CIN), 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 within 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 posttreatment contraceptive method) and herbal remedies containing Hypericum perforatum (St John’s Wort); - Administration of 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) |
Pearl Index (PI), i.e. the number of pregnancies per 100 woman years of exposure for the restricted ITT analysis set; Vaginal bleeding (most relevant parameters: breakthrough bleeding/spotting and absence of withdrawal bleeding)
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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 |
satisfaction and health related quality of life |
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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) | 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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 88 |
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 | 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 date of the last assessment of the last subject undergoing the trial. Pregnancy follow-up may continue after the end of 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 | 1 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |
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 | 11 |