Trial Condition(s):
Assess safety and efficacy of vilaprisan in patients with uterine fibroids (ASTEROID 2)
17541
Not Available
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.
- 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).
- 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.
Locations | |
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Locations Investigative Site Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Innsbruck, Austria, 6020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cagliari, Italy, 09042 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Catania, Italy, 95123 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Modena, Italy, 41124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aravaca, Spain, 28023 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valencia, Spain, 46010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valencia, Spain, 46026 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nesttun, Norway, 5221 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fredrikstad, Norway, 1605 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stavanger, Norway, 4011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Villach, Austria, 9500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bernburg, Germany, 06406 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Blankenburg, Germany, 38889 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Graz, Austria, 8036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nieuwegein, Netherlands, 3435 CM | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Heerlen, Netherlands, 6419 PC | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ZWOLLE, Netherlands, 8025 AB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ALMERE, Netherlands, 1315 RA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stockholm, Sweden, 171 76 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stockholm, Sweden, 118 83 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Umeå, Sweden, 90185 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vilnius, Lithuania, LT-05263 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vilnius, Lithuania, LT-08217 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vilnius, Lithuania, LT-10207 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Helsinki, Finland, 00610 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site EDEGEM, Belgium, 2650 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pori, Finland, 28500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Turku, Finland, 20100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nottingham, United Kingdom, NG7 2UH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Harrow, United Kingdom, HA1 3UJ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, N19 5NF | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Portsmouth, United Kingdom, PO6 3LY | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lørenskog, Norway, 1478 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dresden, Germany, 01307 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 10787 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stara Zagora, Bulgaria, 6000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pleven, Bulgaria, 5800 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sofia, Bulgaria, 1606 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sofia, Bulgaria, 1504 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brno, Czech Republic, 625 00 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 8, Czech Republic, 180 81 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pisek, Czech Republic, 39701 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ceske Budejovice, Czech Republic, 37001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha, Czech Republic, 13000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Olomouc, Czech Republic, 775 20 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Olomouc, Czech Republic, 772 00 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 2, Czech Republic, 120 00 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Plzen, Czech Republic, 30708 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lisboa, Portugal, 1449-005 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Coimbra, Portugal, 3000-075 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Porto, Portugal, 4202-451 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tienen, Belgium, 3300 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Debrecen, Hungary, 4032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Debrecen, Hungary, 4024 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Szentes, Hungary, H-6600 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Budapest, Hungary, 1036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lublin, Poland, 20-632 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bialystok, Poland, 15- 224 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lublin, Poland, 20-093 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lodz, Poland, 90-602 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warszawa, Poland, 02-507 | Contact Us: E-mail: [email protected] Phone: Not Available |
A randomized, parallel-group, double-blind placebo-controlled and open label active controlled, multi-center study to assess the efficacy and safety of vilaprisan in patients with uterine fibroids
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
7