A Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator (34530)(P05702)

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary purpose of this study is to evaluate the use of the next generation applicator and its instructions for proper insertion of the Radiopaque Implant. Secondary objectives include: evaluation of implant removal, evaluation of the overall contraceptive efficacy and safety of the Radiopaque Implant, assessment of x -ray visibility of the Radiopaque Implant, and to assess participant expectations and satisfaction with the Radiopaque Implant.

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

Details

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

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