Trial Condition(s):

Leiomyoma

Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap (ASTEROID 1)

Bayer Identifier:

15788

ClinicalTrials.gov Identifier:

NCT02131662

EudraCT Number:

2013-003945-40

Study Completed

Trial Purpose

The study is performed to assess the efficacy and safety
of different doses of BAY1002670 in subjects with
uterine fibroids. The dose-response relationship will be
evaluated. Further, the study aims to establish a
population pharmacokinetic/pharmacodynamic
relationship for BAY1002670 in subjects with uterine
fibroids. To assess the efficacy of BAY1002670 the
interchangeability of menstrual pictogram and alkaline
hematin method for the judgement of menstrual blood
loss will be assessed.

Inclusion Criteria
-  Signed and dated informed consent
 -  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
-  Pregnancy or lactation
 -  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

Trial Summary

Enrollment Goal
309
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Investigative Site

Stockholm, Sweden, 171 76

Status
Completed
 
Locations

Investigative Site

Uppsala, Sweden, 751 85

Status
Completed
 
Locations

Investigative Site

Göteborg, Sweden, 411 18

Status
Completed
 
Locations

Investigative Site

Oslo, Norway, 0407

Status
Completed
 
Locations

Investigative Site

Trondheim, Norway, 7006

Status
Completed
 
Locations

Investigative Site

Sellebakk, Norway, 1653

Status
Completed
 
Locations

Investigative Site

Trondheim, Norway, 7014

Status
Completed
 
Locations

Investigative Site

Pisek, Czech Republic, 39701

Status
Completed
 
Locations

Investigative Site

Ceske Budejovice, Czech Republic, 370 01

Status
Completed
 
Locations

Investigative Site

Hradec Kralove, Czech Republic, 500 05

Status
Completed
 
Locations

Investigative Site

Bern, Switzerland, 3010

Status
Terminated
 
Locations

Investigative Site

Espoo, Finland, 02100

Status
Completed
 
Locations

Investigative Site

Kuopio, Finland, 70110

Status
Completed
 
Locations

Investigative Site

Helsinki, Finland, 00260

Status
Completed
 
Locations

Investigative Site

Joensuu, Finland, 80100

Status
Completed
 
Locations

Investigative Site

Stara Zagora, Bulgaria, 6000

Status
Completed
 
Locations

Investigative Site

Aravaca, Spain, 28023

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08028

Status
Terminated
 
Locations

Investigative Site

Sevilla, Spain, 41014

Status
Completed
 
Locations

Investigative Site

Pleven, Bulgaria, 5800

Status
Completed
 
Locations

Investigative Site

Sofia, Bulgaria, 1797

Status
Completed
 
Locations

Investigative Site

Sofia, Bulgaria, 1504

Status
Completed
 
Locations

Investigative Site

Sofia, Bulgaria, 1606

Status
Completed
 
Locations

Investigative Site

Karlsruhe, Germany, 76199

Status
Completed
 
Locations

Investigative Site

Blankenburg, Germany, 38889

Status
Completed
 
Locations

Investigative Site

Bernburg, Germany, 06406

Status
Completed
 
Locations

Investigative Site

Berlin, Germany, 12200

Status
Completed
 
Locations

Investigative Site

Valencia, Spain, 46017

Status
Completed
 
Locations

Investigative Site

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
Locations

Investigative Site

LIEGE, Belgium, 4000

Status
Completed
 
Locations

Investigative Site

CHARLEROI, Belgium, 6000

Status
Completed
 
Locations

Investigative Site

Praha 2, Czech Republic, 12808

Status
Completed
 
Locations

Investigative Site

Hamilton, Canada, L8S 4K1

Status
Completed
 
Locations

Investigative Site

Ottawa, Canada, K1H 7W9

Status
Completed
 
Locations

Investigative Site

Winnipeg, Canada, R3T 2E8

Status
Completed
 
Locations

Investigative Site

Pointe-Claire, Canada, H9R 4S3

Status
Terminated
 
Locations

Investigative Site

Quebec, Canada, G1S 2L6

Status
Completed
 
Locations

Investigative Site

Seattle, United States, 98105

Status
Completed
 
Locations

Investigative Site

Tucson, United States, 85712

Status
Completed
 
Locations

Investigative Site

Philadelphia, United States, 19114

Status
Completed
 
Locations

Investigative Site

San Diego, United States, 92108

Status
Completed
 
Locations

Investigative Site

Moorestown, United States, 08057

Status
Completed
 
Locations

Investigative Site

Houston, United States, 77054

Status
Completed
 
Locations

Investigative Site

Denver, United States, 80209

Status
Completed
 
Locations

Investigative Site

New Brunswick, United States, 08901

Status
Completed
 
Locations

Investigative Site

Neptune, United States, 07753

Status
Completed
 
Locations

Investigative Site

Cleveland, United States, 44195

Status
Completed
 
Locations

Investigative Site

San Diego, United States, 92103

Status
Completed
 
Locations

Investigative Site

Lincoln, United States, 68510

Status
Completed
 
Locations

Investigative Site

Erlangen, Germany, 91054

Status
Completed
 
Locations

Investigative Site

Ilsede, Germany, 31241

Status
Terminated
 
Locations

Investigative Site

Lübeck, Germany, 23538

Status
Terminated
 
Locations

Investigative Site

Southington, United States, 06489

Status
Completed
 
Locations

Investigative Site

Norfolk, United States, 23507

Status
Completed
 
Locations

Investigative Site

Szentes, Hungary, 6600

Status
Completed
 
Locations

Investigative Site

Szeged, Hungary, 6725

Status
Completed
 
Locations

Investigative Site

Debrecen, Hungary, 4032

Status
Completed
 
Locations

Investigative Site

Portland, United States, 97239-3011

Status
Completed
 
Locations

Investigative Site

New York, United States, 10038

Status
Completed
 
Locations

Investigative Site

Sapporo, Japan, 004-0052

Status
Completed
 
Locations

Investigative Site

Sapporo, Japan, 064-0808

Status
Completed
 
Locations

Investigative Site

Kita, Japan, 115-0053

Status
Completed
 
Locations

Investigative Site

Kanazawa, Japan, 920-8530

Status
Completed
 
Locations

Investigative Site

Omura, Japan, 856-8562

Status
Completed
 
Locations

Investigative Site

Tacchikawa, Japan, 190-8531

Status
Completed
 
Locations

Investigative Site

Nagano, Japan, 381-8551

Status
Completed
 
Locations

Investigative Site

Iizuka, Japan, 820-8505

Status
Completed
 
Locations

Investigative Site

Numazu, Japan, 410-8555

Status
Completed
 
Locations

Investigative Site

Washington, United States, 20036

Status
Completed
 
Locations

Investigative Site

Pittsburgh, United States, 15213-3180

Status
Terminated
 
Locations

Investigative Site

Jacksonville, United States, 32207

Status
Completed
 
Locations

Investigative Site

Pittsburgh, United States, 15206

Status
Completed
 
Locations

Investigative Site

Marrero, United States, 70072

Status
Completed
 
Locations

Investigative Site

Örebro, Sweden, 701 85

Status
Completed
 
Locations

Investigative Site

Philadelphia, United States, 19104

Status
Completed
 
Locations

Investigative Site

Kumamoto, Japan, 862-8505

Status
Completed
 
Locations

Investigative Site

Gainesville, United States, 32606

Status
Completed
 
Locations

Investigative Site

Nakano-ku, Japan, 164-8541

Status
Completed
 
Locations

Investigative Site

Matsudo, Japan, 270-2267

Status
Completed
 
Locations

Investigative Site

Koriyama, Japan, 963-8585

Status
Completed
 
Locations

Investigative Site

South Miami, United States, 33143

Status
Completed
 
Locations

Investigative Site

Geseke, Germany, 59590

Status
Completed
 
Locations

Investigative Site

Dresden, Germany, 01307

Status
Completed
 
Locations

Investigative Site

Sevilla, Spain, 41013

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08035

Status
Completed
 
Locations

Investigative Site

Praha, Czech Republic, 13000

Status
Completed
 
Locations

Investigative Site

Houston, United States, 77030

Status
Completed
 
Locations

Investigative Site

Columbus, United States, 43231

Status
Completed
 
Locations

Investigative Site

Frisco, United States, 75035

Status
Completed
 
Locations

Investigative Site

Durham, United States, 27713

Status
Completed
 
Locations

Investigative Site

Oulu, Finland, 90100

Status
Completed
 
Locations

Investigative Site

Olomouc, Czech Republic, 772 00

Status
Completed
 
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1070

Status
Completed
 
Locations

Investigative Site

Kecskemet, Hungary, 6000

Status
Completed
 
Locations

Investigative Site

Debrecen, Hungary, 4024

Status
Completed
 
Locations

Investigative Site

Newburgh, United States, 47630

Status
Completed
 
Locations

Investigative Site

Mesa, United States, 85209

Status
Completed
 
Locations

Investigative Site

Naperville, United States, 60540

Status
Completed
 
Locations

Investigative Site

Dallas, United States, 75231

Status
Completed
 
Locations

Investigative Site

Chattanooga, United States, 37404

Status
Completed
 
Locations

Investigative Site

Raleigh, United States, 27612

Status
Completed
 
Locations

Investigative Site

Sandy Springs, United States, 30328

Status
Completed
 
Locations

Investigative Site

Nesttun, Norway, 5221

Status
Completed
 
Locations

Investigative Site

Plantation, United States, 33324

Status
Terminated
 

Trial Design