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With the obiective to find out the efficacy and safety of a single ethylene-vinyl-acetate (EVA) implant containing 3-ketodesogestrel, a phase II study was conducted in 200 women. The study pktnnedfor a two-year use with the possibility to extend the use to 3 or 4 years; 193 subiects completed 2 years, 150 subjects entered the third year and 13 1 subjects completed, 124 subjects entered the fourth year and 96 subjects completed. There was no pregnancy occurred in four years of use, a total exposure of 658.4 woman-years. One subject discontinued due to amenorrhoea (0.5%o). None ofthe subjects discontinuedfor bleeding irregularities, A total of4 subjects (2.0Vo) reported at least one side-effect. No serious side-effects were reported. Three (1.5Vo) subjects discontinued due to siae-effects as primary reason. Side-effects that were considered drug-related were headache and dyspnoea (reported by two and one subjects, respectively). Six subjects once had a clinically significant low value for haemoglobin and for one subject this occurred twice during treatment. Except for " headache" and " dyspnoea" (reported tvvice and once, respectively), no clinically reLevant shifts from normal to abnormal were reported with respect to physical examinations and gynecological evaluations. At implant removal, Pap smear class I was reported for all subjects but one (Pap II). No clinically signfficant values of systolic and diastolic blood pressure were observed. An effect on body mass index was indicated by a slight mean increase (about 2-7Vo) from the month 12 assessment onwards: an increase of 10Vo or more at any time-point was reported by 41 subjects (20.5Vo). It is concluded thnt the single implant contraceptive containing 3-ketodesogestrel is a highty effective contraceptive method with minimal side-effects.

A phase II study with a single implant contraceptive containing 3-ketodesogestrel (Implanon<sup>®</sup>): efficacy and safety