E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The primary objective of this study is to investigate the contraceptive efficacy of the transdermal contraceptive patch (material no. 80876395). |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10060346 |
|
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 primary objective of this study is to investigate the contraceptive efficacy of the transdermal contraceptive patch (material no. 80876395). |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives are bleeding pattern, cycle control and safety profile. Compliance and subjective assessment of satisfaction with the transdermal contraceptive patch will also be evaluated as secondary objectives |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Signed and dated informed consent 2. Healthy female subject requesting contraception 3. Age: 18 � 35 years (inclusive); smokers must not be older than 30 years at the time of informed consent 4. Normal 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) 5. History of regular cyclic menstrual periods |
|
E.4 | Principal exclusion criteria |
1.Pregnancy or lactation (less than 3 menstrual cycles before start of treatment) 2.Obesity (BMI>30.0 kg/m2) 3.Hypersensitivity to any ingredient of the study drug 4.Significant skin reaction to transdermal preparations or sensitivity to surgical/ medical tape 5.Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug (e.g., known skin disease with suspected alteration of dermal absorption or poor adherence of the patch such as psoriasis) 6.Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results 7.Any disease or condition that may worsen under hormonal treatment such as: CV -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, incl.prodromi (e.g., transient ischaemic attack, angina pectoris) and conditions that could increase the risk to suffer from any of the above mentioned disorders, e.g., a family history indicating a hereditary predisposition - repeated measurements of SBP>140 mm Hg and/or DBP>90 mm Hg Liver - presence or history of liver tumors (benign or malignant) -presence or history of severe hepatic disease as long as liver function values have not returned to normal - jaundice and/or pruritus related to cholestasis (Gilbert�s syndrome excepted) - history of cholestatic jaundice associated with pregnancy or previous COC use Metabolic diseases - uncontrolled diabetes mellitus and/or diabetes mellitus with vascular involvement - severe dyslipoproteinemia Other diseases - malignant or premalignant disease - uncontrolled thyroid disorder - severe renal insufficiency or acute renal failure - history of hypertriglyceridemia-associated pancreatitis - pemphigoid gestationis during a previous pregnancy - history of herpes gestationis - otosclerosis-related hearing loss - history of migraine with focal neurologic symptoms - epilepsy - clinically significant depression - hereditary angioedema 8.Undiagnosed abnormal genital bleeding 9.Abuse of alcohol, drugs, or medicines (e.g., laxatives) 10.Other contraceptive methods: - sterilization - oral, vaginal, or transdermal hormonal contraception during treatment - intrauterine devices (IUDs) with or without hormone release - implants - long-acting preparations (e.g., Depot-MPA, monthly contraceptive injection) within a period of 3 times of the injection interval before start of treatment.11.Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results such as: - products containing St.John�s wort (Hypericum perforatum) - antibiotics (except for short-term treatment) - anticoagulants (e.g., heparin, coumarin) - antiepileptics (hydantoin derivatives [e.g., phenytoin] or carboxamide derivatives [e.g., carbamazepine, oxcarbamazepine], others [e.g., felbamate, topiramate]) - hypnotics and sedatives (e.g., barbiturate derivatives, primidone) - tuberculostatics (e.g., rifampicin) - oral antimycotics (e.g., griseofulvin, ketoconazole, itraconazole, fluoconazole) (except for single shot treatment) - virostatic agents (except for topical use [e.g., ritonavir]) - phenylbutazone - additional sex steroids and other drugs impairing ovarian function 12.Simultaneous participation in another clinical trial or prior to study entry that might have an impact on the study objectives, at discretion of investigator 13.Major surgery scheduled during the study period 14.Subject is a dependent person 15 15.Inability to cooperate with the study procedures for any reason |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is the occurrence of pregnancy (yes/no) while on treatment up to 7 days after removal of the last patch, assessed by the Pearl Index and life table analysis |
|
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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 | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
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 | 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 | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |