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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004532-38 | EudraCT Number |
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This study will be performed as a multi-center, randomized, double-blind study in 60 healthy women (2 groups of 30 women) to investigate ovarian activity during simultaneous intake of a COC (containing the estrogen EE and the progestin LNG) and the progesterone receptor modulator (PRM) vilaprisan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COC + Vilaprisan | Experimental | COC + Vilaprisan (BAY 1002670) |
|
| COC + Placebo | Placebo Comparator | COC + Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vilaprisan (BAY 1002670) | Drug | Multiple doses of Vilaprisan for 3 cycles of 28 days each and 7 additional doses on the 7 days after cycle 3. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with ovulation (i.e. Hoogland score = 6) or risk of ovulation (Hoogland score = 5) | treatment day 57 to day 84 | |
| Number of subjects with a Hoogland score = 4 | treatment day 57 to day 84 |
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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 |
|---|---|---|---|---|---|---|
| Dinox GmbH Berlin | Berlin | 10115 | Germany | |||
| CRS Clinical Research Services Berlin GmbH |
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| Vilaprisan Placebo | Drug | Multiple doses of placebo for 3 cycles of 28 days each and 7 additional doses on the 7 days after cycle 3. |
|
| Microgynon | Drug | Multiple doses of Microgynon for 3 cycles of 21 days each (day 1-21) |
|
| Microgynon Placebo | Drug | For the treatment cycle 1-3, 7 doses of Microgynon placebo on Day 22-28 per cycle and after 3 treatment cycles 7 additional doses of Microgynon placebo on the 7 days after cycle 3 (day 84 - 91). |
|
| Berlin |
| 13353 |
| Germany |
| ID | Term |
|---|---|
| C586669 | vilaprisan |
| C072593 | ethinyl estradiol, levonorgestrel drug combination |
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