check_circleStudy Completed

Leiomyoma

Bayer Identifier:

17541

ClinicalTrials.gov Identifier:

NCT02465814

EudraCT Number:

2014-004221-41

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

Female

Age

18 - 50 Years
  • - 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 - 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.

Trial summary

Enrollment Goal
120
Trial Dates
June 2015 - October 2016
Phase
Phase 2
Could I Receive a placebo
No
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of bleeding days
    date_rangeTime Frame:
    Up to 32 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Time to onset of controlled bleeding
    date_rangeTime Frame:
    Up to 28 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Percent change in volume of largest fibroid from baseline to end of treatment.
    date_rangeTime Frame:
    Baseline and up to 28 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Endometrial histology
    (Frequency of the following categories: benign endometrium, endometrial hyperplasia, malignant neoplasm)
    date_rangeTime Frame:
    Baseline and up to 40 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Endometrial thickness measured by transvaginal ultrasound.
    date_rangeTime Frame:
    Baseline and up to 40 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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

Additional Information

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