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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000829-20 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm1 | Experimental | single oral tablet dose of Microgynon (0.03 mg EE and 0.15 mg LNG, fasted) |
|
| Arm2 | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microgynon | Drug | single oral tablet dose of Microgynon (0.03 mg EE and 0.15 mg LNG, fasted) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration time curve (AUC) of Ethinylestradiol (EE) | Plasma concentrations Ethinyl estradiol (EE) and levonorgestrel (LNG) | Up to 4 months |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability | Up to 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mönchengladbach | North Rhine-Westphalia | 41061 | Germany |
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| ID | Term |
|---|---|
| C072593 | ethinyl estradiol, levonorgestrel drug combination |
| C542595 | riociguat |
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| Riociguat (Adempas,BAY63-2521) | Drug | multiple oral tablet doses of 2.5 mg riociguat TID over 12 days and, on the seventh day of this treatment |
|