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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004221-41 | EudraCT Number |
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The study is performed to assess the efficacy of Vilaprisan (BAY1002670) in patients with uterine fibroids compared to placebo and ulipristal. It is also aimed to evaluate the safety of vilaprisan in subjects with uterine fibroids. Further, data on population pharmacokinetic (PK)/ pharmacodynamic (PD) relationship for vilaprisan in subjects with uterine fibroids will be supplemented.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - BAY1002670 + BAY1002670 | Experimental | Vilaprisan (BAY1002670) 2 mg once daily (12 weeks), Vilaprisan 2 mg once daily (12 weeks) |
|
| Arm 2 - Placebo + BAY1002670 | Experimental | Placebo once daily (12 weeks), Vilaprisan 2 mg once daily (12 weeks) |
|
| Arm 3 - BAY1002670 + BAY1002670 | Experimental | Vilaprisan 2 mg once daily (12 weeks), treatment break, Vilaprisan 2 mg once daily (12 weeks) |
|
| Arm 4 - Placebo+BAY1002670 | Experimental | Placebo once daily (12 weeks), treatment break, Vilaprisan 2 mg once daily(12 weeks) |
|
| Arm 5 - Ulipristal + Ulipristal | Active Comparator | Ulipristal 5 mg once daily (12 weeks), treatment break, Ulipristal 5 mg once daily (12 weeks) |
|
| Arm 6- Placebo + Ulipristal |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vilaprisan (BAY1002670) | Drug | Vilaprisan 2 mg (12 weeks), Vilaprisan 2 mg (12 weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amenorrhea (yes/no) | Defined as no scheduled or unscheduled bleeding/spotting after end of the initial bleeding episode until the end of the respective treatment period. | From day 7 to day 84 of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of bleeding days | Up to 32 weeks | |
| Time to onset of controlled bleeding | Up to 28 weeks | |
| Percent change in volume of largest fibroid from baseline to end of 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 |
|---|---|---|---|---|---|---|
| Villach | Carinthia | 9500 | Austria | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32559602 | Derived | Gemzell-Danielsson K, Heikinheimo O, Zatik J, Poka R, Rechberger T, Hudecek R, Petersdorf K, Ramirez F, Faustmann T, Groettrup-Wolfers E, Seitz C. Efficacy and safety of vilaprisan in women with uterine fibroids: Data from the phase 2b randomized controlled trial ASTEROID 2. Eur J Obstet Gynecol Reprod Biol. 2020 Sep;252:7-14. doi: 10.1016/j.ejogrb.2020.05.043. Epub 2020 May 31. |
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| Active Comparator |
Placebo once daily (12 weeks), treatment break, Ulipristal 5 mg once daily (12 weeks) |
|
| Arm 7- Ulipristal + Placebo | Active Comparator | Ulipristal 5 mg once daily (12 weeks), treatment break, Placebo once daily (12 weeks) |
|
| Vilaprisan (BAY1002670 | Drug | Placebo (12 weeks),Vilaprisan (12 weeks) |
|
| Vilaprisan (BAY1002670 | Drug | Vilaprisan 2 mg (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks) |
|
| Vilaprisan (BAY1002670) | Drug | Placebo (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks) |
|
| Ulipristal | Drug | Ulipristal 5 mg (12 weeks), treatment break, Ulipristal 5 mg (12 weeks) |
|
| Ulipristal | Drug | Placebo (12 weeks), treatment break, Ulipristal 5 mg (12 weeks) |
|
| Ulipristal | Drug | Ulipristal (12 weeks), treatment break, Placebo (12 weeks) |
|
| Baseline and up to 28 weeks |
| Endometrial histology | (Frequency of the following categories: benign endometrium, endometrial hyperplasia, malignant neoplasm) | Baseline and up to 40 weeks |
| Endometrial thickness measured by transvaginal ultrasound. | Baseline and up to 40 weeks |
| Vienna |
| State of Vienna |
| 1090 |
| Austria |
| Graz | Styria | 8036 | Austria |
| Innsbruck | Tyrol | 6020 | Austria |
| Tienen | Vlaams Brabant | 3300 | Belgium |
| Bruxelles - Brussel | 1000 | Belgium |
| Edegem | 2650 | Belgium |
| Pleven | 5800 | Bulgaria |
| Sofia | 1504 | Bulgaria |
| Sofia | 1606 | Bulgaria |
| Stara Zagora | 6000 | Bulgaria |
| Brno | 625 00 | Czechia |
| České Budějovice | 37001 | Czechia |
| Olomouc | 772 00 | Czechia |
| Olomouc | 775 20 | Czechia |
| Pilsen | 30708 | Czechia |
| Písek | 39701 | Czechia |
| Prague | 120 00 | Czechia |
| Prague | 13000 | Czechia |
| Prague | 180 81 | Czechia |
| Helsinki | 00610 | Finland |
| Pori | 28500 | Finland |
| Turku | 20100 | Finland |
| Dresden | Saxony | 01307 | Germany |
| Bernburg | Saxony-Anhalt | 06406 | Germany |
| Blankenburg | Saxony-Anhalt | 38889 | Germany |
| Berlin | State of Berlin | 10787 | Germany |
| Budapest | 1036 | Hungary |
| Debrecen | 4024 | Hungary |
| Debrecen | 4032 | Hungary |
| Szentes | H-6600 | Hungary |
| Modena | Emilia-Romagna | 41124 | Italy |
| Cagliari | Sardinia | 09042 | Italy |
| Catania | Sicily | 95123 | Italy |
| Vilnius | LT-05263 | Lithuania |
| Vilnius | LT-08217 | Lithuania |
| Vilnius | LT-10207 | Lithuania |
| Almere Stad | 1315 RA | Netherlands |
| Heerlen | 6419 PC | Netherlands |
| Nieuwegein | 3435 CM | Netherlands |
| Zwolle | 8025 AB | Netherlands |
| Fredrikstad | 1605 | Norway |
| Lørenskog | 1478 | Norway |
| Nesttun | 5221 | Norway |
| Stavanger | 4011 | Norway |
| Bialystok | 15- 224 | Poland |
| Lodz | 90-602 | Poland |
| Lublin | 20-093 | Poland |
| Lublin | 20-632 | Poland |
| Warsaw | 02-507 | Poland |
| Coimbra | Coimbra District | 3000-075 | Portugal |
| Lisbon | Lisbon District | 1449-005 | Portugal |
| Porto | Porto District | 4202-451 | Portugal |
| Barcelona | Barcelona | 08003 | Spain |
| Aravaca | Madrid | 28023 | Spain |
| Valencia | Valencia | 46010 | Spain |
| Valencia | Valencia | 46026 | Spain |
| Stockholm | 118 83 | Sweden |
| Stockholm | 171 76 | Sweden |
| Umeå | 90185 | Sweden |
| Harrow | London | HA1 3UJ | United Kingdom |
| London | N19 5NF | United Kingdom |
| Nottingham | NG7 2UH | United Kingdom |
| Portsmouth | PO6 3LY | United Kingdom |
| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D008595 | Menorrhagia |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
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| ID | Term |
|---|---|
| C586669 | vilaprisan |
| C094854 | ulipristal |
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