Conditions: Contraception
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 301
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: Radiopaque Etonogestrel Implant (drug) inserted with the Next Generation Applicator (NGA)

The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and

2 mm in diameter which is placed at the inner side of the non-dominant upper-arm

about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains

approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.

The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year.

Interventions: intervention 1: Radiopaque Etonogestrel Implant
Intervention descriptions: intervention 1: One implant inserted for a 3-year treatment period

Protocol document: