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

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary purpose of this study is to demonstrate the bioequivalence of IMPLANON and Radiopaque IMPLANON.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Desogestrel; Etonogestrel

Criteria

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