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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001760-22 | EudraCT Number |
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Effects of BAY1002670 on bleeding pattern: non-bleeding rate; on endometrium; on ovarian function; return of menstrual bleeding after treatment; safety and tolerability; PK/PD (pharmacokinetic/pharmacodynamic) relationship
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY1002670 [0.1mg] | Experimental | 0.1 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days |
|
| BAY1002670 [0.5mg] | Experimental | 0.5 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days |
|
| BAY1002670 [1.0mg] | Experimental | 1.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days |
|
| BAY1002670 [2.0mg] | Experimental | 2.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days |
|
| BAY1002670 [5.0mg] | Experimental | 5.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days |
|
| Placebo | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY1002670 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Non-bleeding rate (i.e. women without bleeding from treatment day 9 until the end of treatment) | After three months |
| Measure | Description | Time Frame |
|---|---|---|
| Return of menstrual bleeding after treatment | Up to two months after last treatment |
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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 |
|---|---|---|---|---|---|---|
| Antwerp | 2060 | Belgium | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27288475 | Derived | Schutt B, Kaiser A, Schultze-Mosgau MH, Seitz C, Bell D, Koch M, Rohde B. Pharmacodynamics and safety of the novel selective progesterone receptor modulator vilaprisan: a double-blind, randomized, placebo-controlled phase 1 trial in healthy women. Hum Reprod. 2016 Aug;31(8):1703-12. doi: 10.1093/humrep/dew140. Epub 2016 Jun 10. |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C586669 | vilaprisan |
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Placebo for BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days
|
| Placebo | Drug |
|
| Neu-Ulm |
| Bavaria |
| 89231 |
| Germany |
| Neuss | North Rhine-Westphalia | 41450 | Germany |
| Berlin | State of Berlin | 10117 | Germany |
| Berlin | State of Berlin | 13353 | Germany |
| Belfast | Belfast | BT2 7BA | United Kingdom |