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.
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Female.
Inclusion Criteria:
- Women, 18 to 50 years of age at the time of screening
- Diagnosis of uterine fibroid(s) documented by trans vaginal 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.
- Eligible to undergo surgical treatment for uterine fibroids at the end of study
treatment
- 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 non hormonal 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).
- Women with bleeding/spotting episodes lasting longer than 10 days should not be
included.
- 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.
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Wien 1090, Austria; Recruiting
Bruxelles - Brussel 1000, Belgium; Not yet recruiting
Edegem 2650, Belgium; Not yet recruiting
Pleven 5800, Bulgaria; Not yet recruiting
Sofia 1504, Bulgaria; Not yet recruiting
Sofia 1606, Bulgaria; Terminated
Stara Zagora 6000, Bulgaria; Not yet recruiting
Brno 625 00, Czech Republic; Not yet recruiting
Ceske Budejovice 37001, Czech Republic; Not yet recruiting
Olomouc 772 00, Czech Republic; Recruiting
Olomouc 775 20, Czech Republic; Not yet recruiting
Pisek 39701, Czech Republic; Recruiting
Plzen 30708, Czech Republic; Not yet recruiting
Praha 2 120 00, Czech Republic; Not yet recruiting
Praha 8 180 81, Czech Republic; Not yet recruiting
Praha 13000, Czech Republic; Not yet recruiting
Helsinki 00610, Finland; Not yet recruiting
Pori 28500, Finland; Not yet recruiting
Turku 20100, Finland; Not yet recruiting
Berlin 10787, Germany; Not yet recruiting
Budapest 1036, Hungary; Not yet recruiting
Debrecen 4012, Hungary; Recruiting
Debrecen 4032, Hungary; Not yet recruiting
Szentes H-6600, Hungary; Not yet recruiting
Catania 95123, Italy; Not yet recruiting
Modena 41124, Italy; Recruiting
Vilnius LT-05263, Lithuania; Not yet recruiting
Vilnius LT-08217, Lithuania; Not yet recruiting
Vilnius LT-10207, Lithuania; Not yet recruiting
Almere 1315 RA, Netherlands; Not yet recruiting
Heerlen 6419 PC, Netherlands; Not yet recruiting
Nieuwegein 3435 CM, Netherlands; Not yet recruiting
Zwolle 8025 AB, Netherlands; Not yet recruiting
Fredrikstad 1605, Norway; Not yet recruiting
Lørenskog 1478, Norway; Not yet recruiting
Nesttun 5221, Norway; Not yet recruiting
Stavanger 4011, Norway; Not yet recruiting
Bialystok 15- 224, Poland; Recruiting
Lodz 90-602, Poland; Not yet recruiting
Lublin 20-093, Poland; Not yet recruiting
Lublin 20-632, Poland; Not yet recruiting
Warszawa 02-507, Poland; Not yet recruiting
Coimbra 3000-075, Portugal; Not yet recruiting
Lisboa 1449-005, Portugal; Not yet recruiting
Porto 4202-451, Portugal; Not yet recruiting
Barcelona 08003, Spain; Not yet recruiting
Valencia 46010, Spain; Not yet recruiting
Valencia 46026, Spain; Not yet recruiting
Stockholm 118 83, Sweden; Not yet recruiting
Stockholm 171 76, Sweden; Recruiting
Umeå 90185, Sweden; Not yet recruiting
London N19, United Kingdom; Not yet recruiting
Nottingham NG7 2UH, United Kingdom; Not yet recruiting
Portsmouth PO6 3LY, United Kingdom; Not yet recruiting
Monserrato, Cagliari 09042, Italy; Not yet recruiting
Villach, Kärnten 9500, Austria; Terminated
Harrow, London HA1 3UJ, United Kingdom; Not yet recruiting
Aravaca, Madrid 28023, Spain; Not yet recruiting
Dresden, Sachsen 01307, Germany; Not yet recruiting
Bernburg, Sachsen-Anhalt 06406, Germany; Recruiting
Blankenburg, Sachsen-Anhalt 38889, Germany; Recruiting
Graz, Steiermark 8036, Austria; Not yet recruiting
Innsbruck, Tirol 6020, Austria; Not yet recruiting
Tienen, Vlaams Brabant 3300, Belgium; Not yet recruiting