drugset / Trial / NCT02159326
Microgynon Riociguat Drug Interaction Study in Healthy Postmenopausal Women
RandomizedCrossoverOpen-label
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.
Timeline
- Start
- 2014-06
- Primary completion
- 2015-03
- Completion
- 2015-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Microgynon | Unknown | 0.03 mg | Oral |
| Subject | Microgynon | Unknown | 0.15 mg | Oral |
| Subject | Riociguat | Other / unclassified | 2.5 mg | Oral |
Indications
No indication recorded.