Conditions: Contraception
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 108
Healthy volunteers: yes

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

Detailed description:

Arms:
arm 1: The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate. arm 2: Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and

2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.

The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after

insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year.

Interventions: intervention 1: Radiopaque Implanon intervention 2: Implanon (etonogestrel implant)
Intervention descriptions: intervention 1: Radiopaque rod for 3 years intervention 2: Implanon (etonogestrel implant) for 3 years

Protocol document: