check_circleStudy Completed
Leiomyoma
Bayer Identifier:
17541
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Assess safety and efficacy of vilaprisan in patients with uterine fibroids
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.
Key Participants Requirements
Sex
FemaleAge
18 - 50 YearsTrial summary
Enrollment Goal
120Trial Dates
June 2015 - October 2016Phase
Phase 2Could I Receive a placebo
NoProducts
Vilaprisan (BAY1002670)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Wien, 1090, Austria | |
Terminated | Innsbruck, 6020, Austria | |
Completed | Cagliari, 09042, Italy | |
Completed | Catania, 95123, Italy | |
Completed | Modena, 41124, Italy | |
Completed | Aravaca, 28023, Spain | |
Completed | Barcelona, 08003, Spain | |
Terminated | Valencia, 46010, Spain | |
Completed | Valencia, 46026, Spain | |
Completed | Nesttun, 5221, Norway | |
Completed | Fredrikstad, 1605, Norway | |
Completed | Stavanger, 4011, Norway | |
Terminated | Villach, 9500, Austria | |
Completed | Bernburg, 06406, Germany | |
Completed | Blankenburg, 38889, Germany | |
Terminated | Graz, 8036, Austria | |
Completed | Nieuwegein, 3435 CM, Netherlands | |
Terminated | Heerlen, 6419 PC, Netherlands | |
Completed | ZWOLLE, 8025 AB, Netherlands | |
Completed | ALMERE, 1315 RA, Netherlands | |
Completed | Stockholm, 171 76, Sweden | |
Completed | Stockholm, 118 83, Sweden | |
Completed | Umeå, 90185, Sweden | |
Completed | Vilnius, LT-05263, Lithuania | |
Completed | Vilnius, LT-08217, Lithuania | |
Completed | Vilnius, LT-10207, Lithuania | |
Completed | Helsinki, 00610, Finland | |
Completed | EDEGEM, 2650, Belgium | |
Completed | BRUXELLES - BRUSSEL, 1000, Belgium | |
Completed | Pori, 28500, Finland | |
Completed | Turku, 20100, Finland | |
Terminated | Nottingham, NG7 2UH, United Kingdom | |
Terminated | Harrow, HA1 3UJ, United Kingdom | |
Completed | London, N19 5NF, United Kingdom | |
Completed | Portsmouth, PO6 3LY, United Kingdom | |
Completed | Lørenskog, 1478, Norway | |
Terminated | Dresden, 01307, Germany | |
Terminated | Berlin, 10787, Germany | |
Completed | Stara Zagora, 6000, Bulgaria | |
Completed | Pleven, 5800, Bulgaria | |
Terminated | Sofia, 1606, Bulgaria | |
Completed | Sofia, 1504, Bulgaria | |
Completed | Brno, 625 00, Czech Republic | |
Terminated | Praha 8, 180 81, Czech Republic | |
Completed | Pisek, 39701, Czech Republic | |
Completed | Ceske Budejovice, 37001, Czech Republic | |
Terminated | Praha, 13000, Czech Republic | |
Terminated | Olomouc, 775 20, Czech Republic | |
Completed | Olomouc, 772 00, Czech Republic | |
Terminated | Praha 2, 120 00, Czech Republic | |
Completed | Plzen, 30708, Czech Republic | |
Completed | Lisboa, 1449-005, Portugal | |
Terminated | Coimbra, 3000-075, Portugal | |
Completed | Porto, 4202-451, Portugal | |
Completed | Tienen, 3300, Belgium | |
Completed | Debrecen, 4032, Hungary | |
Completed | Debrecen, 4024, Hungary | |
Completed | Szentes, H-6600, Hungary | |
Terminated | Budapest, 1036, Hungary | |
Completed | Lublin, 20-632, Poland | |
Completed | Bialystok, 15- 224, Poland | |
Completed | Lublin, 20-093, Poland | |
Completed | Lodz, 90-602, Poland | |
Terminated | Warszawa, 02-507, Poland |
Primary Outcome
- 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.date_rangeTime Frame:From day 7 to day 84 of treatment.enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Number of bleeding daysdate_rangeTime Frame:Up to 32 weeksenhanced_encryptionNoSafety Issue:
- Time to onset of controlled bleedingdate_rangeTime Frame:Up to 28 weeksenhanced_encryptionNoSafety Issue:
- Percent change in volume of largest fibroid from baseline to end of treatment.date_rangeTime Frame:Baseline and up to 28 weeksenhanced_encryptionNoSafety Issue:
- Endometrial histology(Frequency of the following categories: benign endometrium, endometrial hyperplasia, malignant neoplasm)date_rangeTime Frame:Baseline and up to 40 weeksenhanced_encryptionYesSafety Issue:
- Endometrial thickness measured by transvaginal ultrasound.date_rangeTime Frame:Baseline and up to 40 weeksenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
7