An open-label, non-controlled multicentre trial to evaluate the insertion characteristics of the radiopaque etonogestrel implant using a next generation applicator
- Conditions
- Hormonal contraception in healthy women
- Registration Number
- EUCTR2006-001452-12-GB
- Lead Sponsor
- V Organon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 300
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the use of the next generation applicator and its instructions for proper insertion of the Radiopaque Implant.;Primary end point(s): User Satisfaction Questionnaire, Insertion and removal characteristics, other insertion and removal variables;<br> Secondary Objective: • To evaluate the removal of the Radiopaque Implant;<br> • To assess overall contraceptive efficacy and safety of the Radiopaque Implant;<br> • To assess X-ray visibility of the Radiopaque Implant.<br> • to assess subject’s expectations and satisfaction with the Radiopaque Implant<br>
- Secondary Outcome Measures
Name Time Method