E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10030970 |
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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 objective of the study is to evaluate the effect of the dispenser’s buzzer function on compliance with daily tablet intake when administered for approximately 12 months to healthy female volunteers between 18 and 45 years of age (inclusive), who request contraception; smokers must not be older than 35 years at the time point of informed consent |
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E.2.2 | Secondary objectives of the trial |
In addition, the efficacy and safety of the oral contraceptive SH T00186D/BAY 86-5300 (0.02 mg EE as betadex clathrate [beta-CDC] and 3 mg DRSP) will be evaluated in a flexible extended regimen administered using a compliance-aiding dispenser (CADDY). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Signed and dated informed consent 2) Healthy female subjects requesting contraception 3) Age between 18 and 35 years (inclusive), smokers must not be older than 30 years at the time point of informed consent 4) Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months). Subjects with ASCUS can be included if they are negative for high-risk HPV strains. (HPV testing in subjects with ASCUS will be used as an adjunctive test). |
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E.4 | Principal exclusion criteria |
-Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment) - Body mass index (BMI) >=30.0 kg/m2 - Presence or a history of venous or arterial thrombotic/thromboembolic events - Repeated measurements of systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg. - Presence or history of liver tumors (benign or malignant), severe hepatic disease, jaundice and/or pruritus related to cholestasis, cholestatic jaundice associated with pregnancy or previous COC use - Uncontrolled diabetes mellitus and/or diabetes mellitus with vascular involvement - Severe dyslipoproteinemia - Malignant or premalignant disease - Uncontrolled thyroid disorder - Chronic inflammatory bowel disease - Severe renal insufficiency or acute renal failure - History of migraine with focal neurologic symptoms - Epilepsy |
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E.5 End points |
E.5.1 | Primary end point(s) |
Mean daily delay of tablet release |
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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 | No |
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) | 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.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 43 |
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
| |
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 | 9 |
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 | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |