Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap
NCT ID: NCT02131662
Last Updated: 2017-12-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
309 participants
INTERVENTIONAL
2014-05-15
2016-05-04
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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VPR 4 mg
BAY1002670
Subjects received 4 milligram (mg) Vilaprisan (VPR) tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
VPR 2 mg
BAY1002670
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
VPR 1 mg
BAY1002670
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
VPR 0.5 mg
BAY1002670
Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Placebo
Placebo
Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Interventions
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BAY1002670
Subjects received 4 milligram (mg) Vilaprisan (VPR) tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
BAY1002670
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
BAY1002670
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
BAY1002670
Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Placebo
Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of uterine fibroid(s) documented by transvaginal or abdominal ultrasound at screening with at least 1 fibroid with largest diameter 3.0 cm
* 18 to 50 years of age at the time of screening
* Heavy menstrual bleeding \>80 mL documented by MP during the bleeding episode following the screening visit
* Normal or clinically insignificant cervical smear not requiring further follow-up
* An endometrial biopsy performed at the screening visit 1 (Visit 1), without significant histological disorder such as endometrial hyperplasia or other significant endometrial pathology
* Use of a non-hormonal barrier method of contraception starting at the bleeding episode following the screening visit 1 (Visit 1) until the end of the study
* Good general health (except for findings related to uterine fibroids)
Exclusion Criteria
* Uterine fibroid with largest diameter \>10.0 cm
* Hypersensitivity to any ingredient of the study drug
* Laboratory values outside inclusion range before randomization and considered as clinically relevant
* Hemoglobin values \<6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values \<10.9 g/dL will receive iron supplementation)
* Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug
18 Years
50 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Mesa, Arizona, United States
Tucson, Arizona, United States
San Diego, California, United States
San Diego, California, United States
Denver, Colorado, United States
Southington, Connecticut, United States
Washington D.C., District of Columbia, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Plantation, Florida, United States
South Miami, Florida, United States
Sandy Springs, Georgia, United States
Naperville, Illinois, United States
Newburgh, Indiana, United States
Marrero, Louisiana, United States
Lincoln, Nebraska, United States
Moorestown, New Jersey, United States
Neptune City, New Jersey, United States
New Brunswick, New Jersey, United States
New York, New York, United States
Durham, North Carolina, United States
Raleigh, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Chattanooga, Tennessee, United States
Dallas, Texas, United States
Frisco, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Norfolk, Virginia, United States
Seattle, Washington, United States
Bruxelles - Brussel, , Belgium
Bruxelles - Brussel, , Belgium
Charleroi, , Belgium
Leuven, , Belgium
Liège, , Belgium
Pleven, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Winnipeg, Manitoba, Canada
Hamilton, Ontario, Canada
Ottawa, Ontario, Canada
Pointe-Claire, Quebec, Canada
Québec, , Canada
České Budějovice, , Czechia
Hradec Králové, , Czechia
Olomouc, , Czechia
Písek, , Czechia
Prague, , Czechia
Prague, , Czechia
Espoo, , Finland
Helsinki, , Finland
Joensuu, , Finland
Kuopio, , Finland
Oulu, , Finland
Karlsruhe, Baden-Wurttemberg, Germany
Erlangen, Bavaria, Germany
Geseke, North Rhine-Westphalia, Germany
Dresden, Saxony, Germany
Bernburg, Saxony-Anhalt, Germany
Blankenburg, Saxony-Anhalt, Germany
Lübeck, Schleswig-Holstein, Germany
Berlin, , Germany
Ilsede, , Germany
Debrecen, , Hungary
Debrecen, , Hungary
Kecskemét, , Hungary
Szeged, , Hungary
Szentes, , Hungary
Matsudo, Chiba, Japan
Iizuka, Fukuoka, Japan
Kōriyama, Fukushima, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Kanazawa, Ishikawa-ken, Japan
Ōmura, Nagasaki, Japan
Numazu, Shizuoka, Japan
Kita-ku, Tokyo, Japan
Nakano-ku, Tokyo, Japan
Tacchikawa, Tokyo, Japan
Kumamoto, , Japan
Nagano, , Japan
Nesttun, , Norway
Oslo, , Norway
Sellebakk, , Norway
Trondheim, , Norway
Trondheim, , Norway
Aravaca, Madrid, Spain
Barcelona, , Spain
Barcelona, , Spain
Seville, , Spain
Seville, , Spain
Valencia, , Spain
Gothenburg, , Sweden
Örebro, , Sweden
Stockholm, , Sweden
Uppsala, , Sweden
Bern, , Switzerland
Countries
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References
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Ren X, Xia J. An algorithm for computing profile likelihood based pointwise confidence intervals for nonlinear dose-response models. PLoS One. 2019 Jan 25;14(1):e0210953. doi: 10.1371/journal.pone.0210953. eCollection 2019.
Bradley LD, Singh SS, Simon J, Gemzell-Danielsson K, Petersdorf K, Groettrup-Wolfers E, Ren X, Zvolanek M, Seitz C. Vilaprisan in women with uterine fibroids: the randomized phase 2b ASTEROID 1 study. Fertil Steril. 2019 Feb;111(2):240-248. doi: 10.1016/j.fertnstert.2018.10.012. Epub 2018 Dec 7.
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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2013-003945-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15788
Identifier Type: -
Identifier Source: org_study_id