Trial Condition(s):

Leiomyoma

Assess safety and efficacy of vilaprisan in patients with uterine fibroids (ASTEROID 2)

Bayer Identifier:

17541

ClinicalTrials.gov Identifier:

NCT02465814

EudraCT Number:

2014-004221-41

Study Completed

Trial Purpose

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.

Inclusion Criteria
-  Women, 18 to 50 years of age at the time of screening
 - Diagnosis of uterine fibroid(s) documented by transvaginal or abdominal ultrasound at screening with at least 1 fibroid with largest diameter >/=3.0 cm
 - Heavy menstrual bleeding (HMB) >80 mL documented by menstrual pictogram (MP) in a bleeding episode during the screening period. Women who did not suffer from perceived HMB during the 3 months prior to Visit 1 due to any effective medical treatment, e.g. with a hormonal contraceptive, are not considered appropriate candidates and should not undergo further screening procedures. Women suffering from perceived HMB despite medical treatment, e.g. with a hormonal contraceptive, are appropriate candidates for further screening, if rules on stopping prior medication are followed. Heavy menstrual bleeding /HMB) > 80 mL should be documented within 10 consecutive days.
 - Good general health (except for findings related to uterine fibroids) as proven by medical history, physical and gynecological examinations, and laboratory test results
 - Normal or clinically insignificant cervical smear not requiring further follow-up. Human papilloma virus (HPV) testing in subjects with atypical squamous cells of undetermined significance (ASCUS) can be used as an adjunctive test. Subjects with ASCUS can be included if they are negative for high-risk HPV strains.
 - An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology.
 - Use of an acceptable nonhormonal method of contraception (i.e. either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at the bleeding episode following the screening visit 1 (Visit 1) until the end of the study. This is not required if safe contraception is achieved by a permanent method, such as bilateral fallopian tube blockage of the subject or vasectomy of the partner(s).
Exclusion Criteria
- Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
 - Uterine fibroid with largest diameter >10.0 cm
 - Hypersensitivity to any ingredient of the study drugs
 - Hemoglobin values </= 6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values </=10.9 g/dL will be offered 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
 - Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
 - Abuse of alcohol, drugs, or medicines (e.g. laxatives)
 - Use of other treatments that might interfere with the conduct of the study or the interpretation of the results 
 - Undiagnosed abnormal genital bleeding.

Trial Summary

Enrollment Goal
120
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Investigative Site

Wien, Austria, 1090

Status
Completed
 
Locations

Investigative Site

Innsbruck, Austria, 6020

Status
Terminated
 
Locations

Investigative Site

Cagliari, Italy, 09042

Status
Completed
 
Locations

Investigative Site

Catania, Italy, 95123

Status
Completed
 
Locations

Investigative Site

Modena, Italy, 41124

Status
Completed
 
Locations

Investigative Site

Aravaca, Spain, 28023

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08003

Status
Completed
 
Locations

Investigative Site

Valencia, Spain, 46010

Status
Terminated
 
Locations

Investigative Site

Valencia, Spain, 46026

Status
Completed
 
Locations

Investigative Site

Nesttun, Norway, 5221

Status
Completed
 
Locations

Investigative Site

Fredrikstad, Norway, 1605

Status
Completed
 
Locations

Investigative Site

Stavanger, Norway, 4011

Status
Completed
 
Locations

Investigative Site

Villach, Austria, 9500

Status
Terminated
 
Locations

Investigative Site

Bernburg, Germany, 06406

Status
Completed
 
Locations

Investigative Site

Blankenburg, Germany, 38889

Status
Completed
 
Locations

Investigative Site

Graz, Austria, 8036

Status
Terminated
 
Locations

Investigative Site

Nieuwegein, Netherlands, 3435 CM

Status
Completed
 
Locations

Investigative Site

Heerlen, Netherlands, 6419 PC

Status
Terminated
 
Locations

Investigative Site

ZWOLLE, Netherlands, 8025 AB

Status
Completed
 
Locations

Investigative Site

ALMERE, Netherlands, 1315 RA

Status
Completed
 
Locations

Investigative Site

Stockholm, Sweden, 171 76

Status
Completed
 
Locations

Investigative Site

Stockholm, Sweden, 118 83

Status
Completed
 
Locations

Investigative Site

Umeå, Sweden, 90185

Status
Completed
 
Locations

Investigative Site

Vilnius, Lithuania, LT-05263

Status
Completed
 
Locations

Investigative Site

Vilnius, Lithuania, LT-08217

Status
Completed
 
Locations

Investigative Site

Vilnius, Lithuania, LT-10207

Status
Completed
 
Locations

Investigative Site

Helsinki, Finland, 00610

Status
Completed
 
Locations

Investigative Site

EDEGEM, Belgium, 2650

Status
Completed
 
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1000

Status
Completed
 
Locations

Investigative Site

Pori, Finland, 28500

Status
Completed
 
Locations

Investigative Site

Turku, Finland, 20100

Status
Completed
 
Locations

Investigative Site

Nottingham, United Kingdom, NG7 2UH

Status
Terminated
 
Locations

Investigative Site

Harrow, United Kingdom, HA1 3UJ

Status
Terminated
 
Locations

Investigative Site

London, United Kingdom, N19 5NF

Status
Completed
 
Locations

Investigative Site

Portsmouth, United Kingdom, PO6 3LY

Status
Completed
 
Locations

Investigative Site

Lørenskog, Norway, 1478

Status
Completed
 
Locations

Investigative Site

Dresden, Germany, 01307

Status
Terminated
 
Locations

Investigative Site

Berlin, Germany, 10787

Status
Terminated
 
Locations

Investigative Site

Stara Zagora, Bulgaria, 6000

Status
Completed
 
Locations

Investigative Site

Pleven, Bulgaria, 5800

Status
Completed
 
Locations

Investigative Site

Sofia, Bulgaria, 1606

Status
Terminated
 
Locations

Investigative Site

Sofia, Bulgaria, 1504

Status
Completed
 
Locations

Investigative Site

Brno, Czech Republic, 625 00

Status
Completed
 
Locations

Investigative Site

Praha 8, Czech Republic, 180 81

Status
Terminated
 
Locations

Investigative Site

Pisek, Czech Republic, 39701

Status
Completed
 
Locations

Investigative Site

Ceske Budejovice, Czech Republic, 37001

Status
Completed
 
Locations

Investigative Site

Praha, Czech Republic, 13000

Status
Terminated
 
Locations

Investigative Site

Olomouc, Czech Republic, 775 20

Status
Terminated
 
Locations

Investigative Site

Olomouc, Czech Republic, 772 00

Status
Completed
 
Locations

Investigative Site

Praha 2, Czech Republic, 120 00

Status
Terminated
 
Locations

Investigative Site

Plzen, Czech Republic, 30708

Status
Completed
 
Locations

Investigative Site

Lisboa, Portugal, 1449-005

Status
Completed
 
Locations

Investigative Site

Coimbra, Portugal, 3000-075

Status
Terminated
 
Locations

Investigative Site

Porto, Portugal, 4202-451

Status
Completed
 
Locations

Investigative Site

Tienen, Belgium, 3300

Status
Completed
 
Locations

Investigative Site

Debrecen, Hungary, 4032

Status
Completed
 
Locations

Investigative Site

Debrecen, Hungary, 4024

Status
Completed
 
Locations

Investigative Site

Szentes, Hungary, H-6600

Status
Completed
 
Locations

Investigative Site

Budapest, Hungary, 1036

Status
Terminated
 
Locations

Investigative Site

Lublin, Poland, 20-632

Status
Completed
 
Locations

Investigative Site

Bialystok, Poland, 15- 224

Status
Completed
 
Locations

Investigative Site

Lublin, Poland, 20-093

Status
Completed
 
Locations

Investigative Site

Lodz, Poland, 90-602

Status
Completed
 
Locations

Investigative Site

Warszawa, Poland, 02-507

Status
Terminated
 

Trial Design