A single-arm study to evaluate the transfer of drospirenone to breastmilk after reaching steady state following oral administration of 4 mgdrospirenone in healthy lactating female volunteers

摘要

The primary objective of this trial was to assess the transfer ofdrospirenone to breast milk after daily administration of an oral testpreparation containing 4 mg of drospirenone at the steady state. Thesecondary objective of the trial was to assess safety based on clinical andlaboratory measurements and reporting of adverse events and/or adverse drugreactions.