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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Vilaprisan 2 mg (12 weeks), Vilaprisan 2 mg (12 weeks)
Placebo (12 weeks),Vilaprisan (12 weeks)
Vilaprisan 2 mg (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks)
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.
Time frame: From day 7 to day 84 of treatment.
Number of bleeding days
Time frame: Up to 32 weeks
Time to onset of controlled bleeding
Time frame: Up to 28 weeks
Percent change in volume of largest fibroid from baseline to end of treatment.
Time frame: Baseline and up to 28 weeks
Endometrial histology
(Frequency of the following categories: benign endometrium, endometrial hyperplasia, malignant neoplasm)
Time frame: Baseline and up to 40 weeks
Endometrial thickness measured by transvaginal ultrasound.
Time frame: Baseline and up to 40 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Placebo (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks)
Ulipristal 5 mg (12 weeks), treatment break, Ulipristal 5 mg (12 weeks)
Placebo (12 weeks), treatment break, Ulipristal 5 mg (12 weeks)
Ulipristal (12 weeks), treatment break, Placebo (12 weeks)
Unnamed facility
Villach, Carinthia, Austria
Unnamed facility
Vienna, State of Vienna, Austria
Unnamed facility
Graz, Styria, Austria
Unnamed facility
Innsbruck, Tyrol, Austria
Unnamed facility
Tienen, Vlaams Brabant, Belgium
Unnamed facility
Bruxelles - Brussel, Belgium
Unnamed facility
Edegem, Belgium
Unnamed facility
Pleven, Bulgaria
Unnamed facility
Sofia, Bulgaria
Unnamed facility
Sofia, Bulgaria
...and 54 more locations