Assess Safety and Efficacy of Vilaprisan in Patients With Uterine Fibroids
NCT ID: NCT02465814
Last Updated: 2016-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2015-06-30
2016-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1 - BAY1002670 + BAY1002670
Vilaprisan (BAY1002670) 2 mg once daily (12 weeks), Vilaprisan 2 mg once daily (12 weeks)
Vilaprisan (BAY1002670)
Vilaprisan 2 mg (12 weeks), Vilaprisan 2 mg (12 weeks)
Arm 2 - Placebo + BAY1002670
Placebo once daily (12 weeks), Vilaprisan 2 mg once daily (12 weeks)
Vilaprisan (BAY1002670
Placebo (12 weeks),Vilaprisan (12 weeks)
Arm 3 - BAY1002670 + BAY1002670
Vilaprisan 2 mg once daily (12 weeks), treatment break, Vilaprisan 2 mg once daily (12 weeks)
Vilaprisan (BAY1002670
Vilaprisan 2 mg (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks)
Arm 4 - Placebo+BAY1002670
Placebo once daily (12 weeks), treatment break, Vilaprisan 2 mg once daily(12 weeks)
Vilaprisan (BAY1002670)
Placebo (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks)
Arm 5 - Ulipristal + Ulipristal
Ulipristal 5 mg once daily (12 weeks), treatment break, Ulipristal 5 mg once daily (12 weeks)
Ulipristal
Ulipristal 5 mg (12 weeks), treatment break, Ulipristal 5 mg (12 weeks)
Arm 6- Placebo + Ulipristal
Placebo once daily (12 weeks), treatment break, Ulipristal 5 mg once daily (12 weeks)
Ulipristal
Placebo (12 weeks), treatment break, Ulipristal 5 mg (12 weeks)
Arm 7- Ulipristal + Placebo
Ulipristal 5 mg once daily (12 weeks), treatment break, Placebo once daily (12 weeks)
Ulipristal
Ulipristal (12 weeks), treatment break, Placebo (12 weeks)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vilaprisan (BAY1002670)
Vilaprisan 2 mg (12 weeks), Vilaprisan 2 mg (12 weeks)
Vilaprisan (BAY1002670
Placebo (12 weeks),Vilaprisan (12 weeks)
Vilaprisan (BAY1002670
Vilaprisan 2 mg (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks)
Vilaprisan (BAY1002670)
Placebo (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks)
Ulipristal
Ulipristal 5 mg (12 weeks), treatment break, Ulipristal 5 mg (12 weeks)
Ulipristal
Placebo (12 weeks), treatment break, Ulipristal 5 mg (12 weeks)
Ulipristal
Ulipristal (12 weeks), treatment break, Placebo (12 weeks)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
* 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
* 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.
18 Years
50 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bayer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Villach, Carinthia, Austria
Graz, Styria, Austria
Innsbruck, Tyrol, Austria
Vienna, Vienna, Austria
Tienen, Vlaams Brabant, Belgium
Bruxelles - Brussel, , Belgium
Edegem, , Belgium
Pleven, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Brno, , Czechia
České Budějovice, , Czechia
Olomouc, , Czechia
Olomouc, , Czechia
Pilsen, , Czechia
Písek, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Helsinki, , Finland
Pori, , Finland
Turku, , Finland
Dresden, Saxony, Germany
Bernburg, Saxony-Anhalt, Germany
Blankenburg, Saxony-Anhalt, Germany
Berlin, State of Berlin, Germany
Budapest, , Hungary
Debrecen, , Hungary
Debrecen, , Hungary
Szentes, , Hungary
Modena, Emilia-Romagna, Italy
Cagliari, Sardinia, Italy
Catania, Sicily, Italy
Vilnius, , Lithuania
Vilnius, , Lithuania
Vilnius, , Lithuania
Almere Stad, , Netherlands
Heerlen, , Netherlands
Nieuwegein, , Netherlands
Zwolle, , Netherlands
Fredrikstad, , Norway
Lørenskog, , Norway
Nesttun, , Norway
Stavanger, , Norway
Bialystok, , Poland
Lodz, , Poland
Lublin, , Poland
Lublin, , Poland
Warsaw, , Poland
Coimbra, Coimbra District, Portugal
Lisbon, Lisbon District, Portugal
Porto, Porto District, Portugal
Barcelona, Barcelona, Spain
Aravaca, Madrid, Spain
Valencia, Valencia, Spain
Valencia, Valencia, Spain
Stockholm, , Sweden
Stockholm, , Sweden
Umeå, , Sweden
Harrow, London, United Kingdom
London, , United Kingdom
Nottingham, , United Kingdom
Portsmouth, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014-004221-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17541
Identifier Type: -
Identifier Source: org_study_id