| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | |
| 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 | | The objective of this study is to show that the safety and efficacy of an extended oral contraceptive treatment with Belara/CG5025 taken for two 196-days cycles (189 days with active pill intake plus 7 days pill-free interval) is comparable with the safety and efficacy of the conventional treatment, i.e. Belara/CG5025 taken for fourteen 28-days cycles (21 days with active pill intake plus 7 days pill-free interval), where in the EC group the mean number of days with intermenstrual bleeding related to the number of potential days with intermenstrual bleeding does not exceed 16.0% during two ECs. | |
| E.2.2 | Secondary objectives of the trial | |
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria | - Healthy, sexual active woman of child-bearing potential aged 18 - 40 years (non smoker) or 18 - 35 years (smoker) at admission
- Laboratory values with no deviations of any clinical relevance for the course of the study in the opinion of the investigator
- Wish for oral contraception for at least 392 days
- BMI ≤ 30
- HEMOSTATIC/METABOLIC SUBGROUP:
- Healthy, non-smoking, sexual active woman of child-bearing potential aged 18 - 40 years at admission
- Wish for oral contraception for at least 392 days followed by approximately 2 months with a barrier method, e.g. condoms
| |
| E.4 | Principal exclusion criteria | General criteria
- Pregnancy
- Breast feeding
- Evidence or history of alcohol, medication or drug dependency
- Severe psychiatric illness, epilepsy or suicide risk
- Any chronic disease (e.g. hepatic and/or renal) or diet that might affect drug absorption, metabolism or excretion
Study specific
- Planned surgery requiring withdrawal of an oral contraceptive during the anticipated time of participation in this study
- Cytologic evidence of intraepithelial neoplasia in a cervical smear (e.g. Pap smear grade III to V)
- Unexplained amenorrhea or genital bleeding
-Known polycystic ovary syndrome, anovulatory cycles, hysterectomy, bilateral oophorectomy
- Administration of any other hormonal contraceptives including patches and vaginal rings during the medication cycles
- Use of intra-uterine devices (IUD) with or without hormone impregnation during the medication cycles
- Use of implantable contraceptives during the medication cycles
- Use of injectable contraceptives within the preceding 6 months (date of injection) before admission and during the medication cycles
- Use of estrogen or progesterone containing medication during the medication cycles
- Regular concomitant use of a barrier method
- Migraine with focal neurological symptoms (migraine accompagnée)
- Need for concomitant treatment (longer than 5 days) with
• medicines that increase gastrointestinal motility (e.g. metoclopramide) or impair absorption (e.g. activated charcoal)
• active substances inducing microsomal enzymes in the liver such as rifampicin, rifabutin, barbiturates, anti-epileptics (e.g. phenytoin, carbamazepine, oxcarbazepine, topiramate, felbamate, primidone, barbexaclone), griseofulvin, modafinil, protease inhibitors (e.g. ritonavir), or St. John’s Wort
• antibiotics
- Hepatic diseases
- Circulation affecting and metabolic diseases
- Pancreatitis or history of such a condition, if associated with severe hypertriglyceridemia
- Tumors: presence, history or suspicion of any malignant or hormone-sensitive tumor
- Other diseases:
• Porphyria (in particular acquired hepatic porphyria)
• Otosclerosis deteriorating in previous pregnancies
• Acute sensory disorders, e.g. visual or hearing disorders
• Motor disorders, particularly paresis
• Severe epigastric pain, enlargement of the liver, or symptoms of intraabdominal hemorrhage
Study specific for volunteers in hemostatic/metabolic subgroup
- Use of oral contraceptives, contraceptive vaginal rings, or contraceptive patches within 1 cycle before the pre-medication cycle
- Concomitant and prior use of intra-uterine devices (IUD) with or without hormone impregnation within 1 cycle before the pre-medication cycle
- Use of implantable contraceptives within the preceding 2 cycles before the pre-medication cycle
- Parturition, miscarriage, or abortion within the preceding 3 months before the baseline visit
- Concomitant use of anticoagulants, i.e. heparins and coumarins
- Concomitant medications affecting the lipoprotein and/or carbohydrate metabolism (e.g. systemic glucocorticoides, ß-blockers, thiazide diuretics, antilipemic agents)
- Concomitant diseases affecting the lipoprotein and/or carbohydrate metabolism (e.g. diabetes mellitus, hypothyroidism, cholestasis, nephrotic syndrome, renal insufficiency requiring hemodialysis)
- Fasting total cholesterol > 6.47 mmol/l (> 250 mg/dl) and/or triglycerides > upper limit of normal at baseline
- Concomitant use of platelet aggregation inhibitors and/or non-steroidal anti-inflammatory drugs (NSAIDs) within 7 days prior to blood sampling either at baseline, visit 4, 6, and 7B
| |
| E.5 End points |
| E.5.1 | Primary end point(s) | - number of days with intermenstrual bleeding related to the number of potential days with intermenstrual bleeding during 392 days,
- total number of days with bleeding during 392 days and within each of 4 reference periods of 98 days,
- intensity of bleeding
| |
| 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 | Yes |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| 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 | 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 | 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) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description | | different regimen : two extended cycles in comparison to conventional regimen | |
| 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 | |
| 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 | | last visit of last subject | |
| 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 |
