Microgynon Riociguat Drug Interaction Study in Healthy Postmenopausal Women
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm1 single oral tablet dose of Microgynon (0.03 mg EE and 0.15 mg LNG, fasted) |
Drug: Microgynon
single oral tablet dose of Microgynon (0.03 mg EE and 0.15 mg LNG, fasted)
|
| Experimental: Arm2 multiple oral tablet doses of 2.5 mg riociguat TID over 12 days and, on the seventh day of this treatment, a single oral tablet dose of Microgynon (0.03 mg EE and 0.15 mg LNG, fasted) |
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
|
Outcome Measures
Primary Outcome Measures
- Area under the plasma concentration time curve (AUC) of Ethinylestradiol (EE) [Up to 4 months]
Plasma concentrations Ethinyl estradiol (EE) and levonorgestrel (LNG)
- Area under the plasma concentration time curve (AUC) of Levonorgestrel (LNG) [Up to 4 months]
- Maximal concentration (Cmax) of Ethinylestradiol (EE) [Up to 4 months]
- Maximal concentration (Cmax) of Levonorgestrel (LNG) [Up to 4 months]
Secondary Outcome Measures
- Number of participants with adverse events as a measure of safety and tolerability [Up to 4 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy female subject
-
Non-smokers of at least 3 month before screening
-
Age: 52 to 65 years (inclusive) at the first screening examination
-
Ethnicity: white
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Body mass index (BMI)>=20 and <=32 kg/m2
-
Postmenopausal state, defined as
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Medical history, if applicable (natural menopause at least 12 months before the first study drug administration and hormone analyses in serum
-
Age<60 years: follicle-stimulating hormone (FSH) >40 IU/L in plasma
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Age <60 years: estradiol (E2) <20 ng/L (<73 pmol/L) in plasma
Exclusion Criteria:
-
History of coronary artery disease, Symptomatic postural hypotension, History of bronchial asthma, known hypersensitivity to the study, relevant diseases within 4 weeks before study drug administration,
-
Presence or a history of venous or arterial thrombotic / thromboembolic events or cerebrovascular accident, a high risk for venous or arterial thrombosis,
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Use of systemic or topical medicines or substances which oppose the study objectives, smoking, use of sex hormones in any forms
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Clinically relevant findings in the ECG, systolic blood pressure below 110 or above 145 mmHg, heart rate below 50 or above 95 beats per minute
-
Clinically relevant findings in the gynecological examination,
-
Participation in another clinical study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mönchengladbach | Nordrhein-Westfalen | Germany | 41061 |
Sponsors and Collaborators
- Bayer
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17309
- 2014-000829-20