MULTICENTER CLINICAL-TRIAL ON THE EFFICACY AND ACCEPTABILITY OF A SINGLE CONTRACEPTIVE IMPLANT OF NOMEGESTROL ACETATE, UNIPLANT

Uniplant, a single Silastic implant containing nomegestrol acetate, pr ovides contraceptive efficacy for one year. Uniplant use for one year was studied in 1,803 healthy women of reproductive age, enrolled from 10 centers in 9 countries, after informed consent. Implants were place d subdermally either in the upper arm or in the gluteal region. Two-hu ndred-seventy-six subjects discontinued prior to completing one year o f study. Cumulative discontinuation rate at 12 months was 15.72%. Medi cal reasons for discontinuation were principally menstrual-related. Fi fteen pregnancies occurred during the one year study period, resulting in a 12-month net cumulative pregnancy rate of 0.94%. Approximately 5 6% of subjects using Uniplant had bleeding patterns similar to normal menstruation. Results from this study confirm that Uniplant is an effi cient, well tolerated, 12-month contraceptive implant, with the advant age of easier insertion and removal of the single implant compared to other multiple implant methods.