An open-label, non-controlled multicentre trial to evaluate the insertion characteristics of the radiopaque etonogestrel implant using a next generation applicator

V Organon0 个研究点目标入组 300 人开始时间: 2007年2月12日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. Woman of at least (=)18 but not older than (=)40 years of age at the time of screening;
•2. Good physical and mental health;
•3. Regular cycles with a usual length between 24 and 35 days;
•4. Body mass index =18 and =35 kg/m2;
•5. Willing to give informed consent in writing.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Contraindications:
•- known or suspected pregnancy;
•- active venous thromboembolic disorder (e.g. deep vein thrombosis, pulmonary embolism);
•- presence or history of severe hepatic disease as long as liver function values have not returned to normal;
•- malignancy or pre-malignancy, if sex-steroid-influenced;
•- undiagnosed vaginal bleeding;
•- hypersensitivity to any of the components of Radiopaque Implant.
•2. Hypertension, i.e. systolic blood pressure >140 mmHg and/or diastolic blood pressure > 90 mmHg;
•3. A history during pregnancy or during previous use of sex steroids of: jaundice and/or severe pruritus related to cholestasis, gallstone formation, porphyria, systemic lupus erythematosus, haemolytic uraemic syndrome, Sydenham’s chorea, herpes gestationis, otosclerosis-related hearing loss;
•4. Present use or use during 2 months prior to the start of Radiopaque Implant of one of the following drugs: phenytoin, phenobarbital, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, ritonavir, nelfinavir, griseofulvin or the herbal remedy St John’s wort;
•5. Administration of investigational drugs within 2 months prior to the start of Radiopaque Implant.

发起方

V Organon