NCT02159326

Microgynon Riociguat Drug Interaction Study in Healthy Postmenopausal Women

Microgynon Riociguat Drug Interaction Study to Investigate the Effect of Riociguat 2.5 mg 3 Times Daily Multiple-dose Treatment on the Plasma Concentrations of / Exposure to Levonorgestrel and Ethinyl Estradiol in Healthy Postmenopausal Women in a 2-fold Crossover Design

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 52 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Drug Interactions

Interventions

Type	Name	Description
DRUG	Microgynon	single oral tablet dose of Microgynon (0.03 mg EE and 0.15 mg LNG, fasted)
DRUG	Riociguat (Adempas,BAY63-2521)	multiple oral tablet doses of 2.5 mg riociguat TID over 12 days and, on the seventh day of this treatment

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-03-01
• Completion: 2015-07-01
• First posted: 2014-06-09
• Last updated: 2015-08-14

Locations

1 site across 1 country: Germany