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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000329-19 | EudraCT Number |
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This is a study in healthy women of reproductive age to investigate the pharmacodynamics (mainly ovarian activity), pharmacokinetics and safety of vilaprisan after daily oral administration of 4 different doses over 84 days, using a randomized, parallel-group, multicenter design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vilaprisan [0.5mg] | Experimental | 0.5 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days |
|
| Vilaprisan [1mg] | Experimental | 1 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days |
|
| Vilaprisan [2mg] | Experimental | 2 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days |
|
| Vilaprisan [4mg] | Experimental | 4 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vilaprisan (BAY1002670) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hoogland score during treatment, day 9 to day 28 | based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations | Day 9 to 28 |
| Hoogland score during treatment, day 63 to day 84 | based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations | Day 63 to 84 |
| Hoogland score during follow up cycle 1 | based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations | 4 weeks following treatment period |
| Hoogland score during follow up cycle 2 | based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations | 4 weeks following follow up cycle 1 |
| Number of subjects without bleeding/spotting | After three month treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Exposure-response analysis of vilaprisan by population pharmacokinetic/pharmacodynamic modeling | After three month treatment | |
| Number of subjects with TEAEs (treatment-emergent adverse events) | After three month treatment and during follow-up (up to 60 days) |
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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 |
|---|---|---|---|---|---|---|
| Berlin | State of Berlin | 10115 | Germany | |||
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| ID | Term |
|---|---|
| C586669 | vilaprisan |
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| Number of subjects with PAEC (progesterone-receptor-modulator associated endometrial changes) | After three month treatment and during follow-up (up to 60 days) |
| Berlin |
| State of Berlin |
| 13353 |
| Germany |