What are the other possible disadvantages of taking part?
No studies of empagliflozin or vicadrostat (BI 690517) have been performed in pregnant or breastfeeding women or infants and it is possible that either medication could affect an unborn child. Women who are pregnant, plan to get pregnant or are breastfeeding cannot join the study. Women who could become pregnant must agree to use highly effective contraception1 throughout the trial and for a week after the end of the study (types of contraception which are considered highly effective are listed below).
If you become pregnant during the trial (or wish to do so), you should stop taking your study pills and tell the local study team or study doctor promptly so appropriate action can be taken. Your local study doctor will keep in contact with you during and after your pregnancy to follow-up your pregnancy and collect monitoring information.
If you have private medical insurance or require travel insurance, your policy may be affected by joining the study, so please check with your insurance provider.
1 Highly effective methods of contraception include implants, injections, combined oral contraceptive pills (started at least three months before joining the trial), intrauterine devices (often known as a coil), vasectomised partner, or true and complete abstinence (ie not calendar or temperature methods).