European journal of obstetrics, gynecology, and reproductive biology
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Eur. J. Obstet. Gynecol. Reprod. Biol. · Mar 2010
Randomized Controlled Trial Multicenter StudyEfficacy and safety of a novel oral contraceptive based on oestradiol (oestradiol valerate/dienogest): a Phase III trial.
A novel oral contraceptive (OC) that contains oestradiol valerate (E2V; 1 mg of E2V is equivalent to 0.76 mg of 17beta-oestradiol) and dienogest (DNG) has been developed. The efficacy and safety of this formulation was assessed in the current study. ⋯ A novel OC based on oestradiol provides highly effective and reliable contraception. This is achieved through the combination of oestradiol valerate (E2V) and dienogest (DNG) administered using an oestrogen step-down and a progestin step-up approach over 26 days of active treatment followed by 2 days of placebo. The preparation is well tolerated and is associated with a high degree of user satisfaction and a low discontinuation rate.