Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT00620035
Eligibility Criteria:
Inclusion Criteria:
* Woman of at least (\>=) 18 but not older than (\<= )40 years of age at the time of screening;
* Good physical and mental health;
* Regular cycles with a usual length between 24 and 35 days;
* Body mass index \>= 18 and \<= 35 kg/m\^2;
* Willing to give informed consent in writing.
Exclusion Criteria:
* 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.
* Hypertension, i.e. systolic blood pressure \>140 mmHg and/or diastolic blood pressure \> 90 mmHg;
* 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;
* 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;
* Administration of investigational drugs within 2 months prior to the start of Radiopaque Implant
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT00620035
Study Brief:
Protocol Section:
NCT00620035