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Microgynon Riociguat Drug Interaction Study in Healthy Postmenopausal Women

NCT02159326 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2015-08-14

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
52 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-03-31
Completion
2015-07-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02159326 on ClinicalTrials.gov