A Bioequivalence Study of IMPLANON and Radiopaque IMPLANON (34528)(P05720)

Inclusion criteria

• 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 ≤ 29
• 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 Implanon/Radiopaque Implanon
• 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 Implanon/Radiopaque Implanon 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 Implanon/Radiopaque Implanon