Microgynon Riociguat Drug Interaction Study in Healthy Postmenopausal Women
Status:
Completed
Trial end date:
2015-07-01
Target enrollment:
Participant gender:
Summary
Physicians might be concerned that Adempas may have a metabolic interaction with oral
contraceptives (OC) that could decrease the contraceptive efficacy of the OC. The information
regarding lack of potential pharmacokinetic interaction has been communicated; there is a
need for more re-assurance and further data that there is no interaction between Adempas and
OCs. A drug-drug interaction study of riociguat with an OC such as Microgynon in the least
vulnerable population for these purposes, i.e. healthy postmenopausal women, is considered
adequate to inform about safe use of Adempas with OCs.
Phase:
Phase 1
Details
Lead Sponsor:
Bayer
Treatments:
Ethinyl Estradiol-Norgestrel Combination Ethinyl estradiol, levonorgestrel drug combination Riociguat