check_circleStudy Completed

Leiomyoma

Bayer Identifier:

15788

ClinicalTrials.gov Identifier:

NCT02131662

EudraCT Number:

2013-003945-40

EU CT Number:

Not Available
Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap

Trial purpose

The study is performed to assess the efficacy and safety
of different doses of BAY1002670 in subjects with
uterine fibroids. The dose-response relationship will be
evaluated. Further, the study aims to establish a
population pharmacokinetic/pharmacodynamic
relationship for BAY1002670 in subjects with uterine
fibroids. To assess the efficacy of BAY1002670 the
interchangeability of menstrual pictogram and alkaline
hematin method for the judgement of menstrual blood
loss will be assessed.

Key Participants Requirements

Sex

Female

Age

18 - 50 Years
  • - Signed and dated informed consent
    - Diagnosis of uterine fibroid(s) documented by
    transvaginal or abdominal ultrasound at screening with
    at least 1 fibroid with largest diameter 3.0 cm
    - 18 to 50 years of age at the time of screening
    - Heavy menstrual bleeding >80 mL documented by
    MP during the bleeding episode following the screening visit
    - Normal or clinically insignificant cervical smear not
    requiring further follow-up
    - An endometrial biopsy performed at the screening
    visit 1 (Visit 1), without significant histological disorder
    such as endometrial hyperplasia or other significant
    endometrial pathology
    - Use of a non-hormonal barrier method of
    contraception starting at the bleeding episode following
    the screening visit 1 (Visit 1) until the end of the study
    - Good general health (except for findings related to
    uterine fibroids)
  • - Pregnancy or lactation
    - Uterine fibroid with largest diameter >10.0 cm
    - Hypersensitivity to any ingredient of the study drug
    - Laboratory values outside inclusion range before
    randomization and considered as clinically relevant
    - Hemoglobin values <6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values <10.9 g/dL will receive 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

Trial summary

Enrollment Goal
309
Trial Dates
May 2014 - May 2016
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Stockholm, 171 76, Sweden
Completed
Uppsala, 751 85, Sweden
Completed
Göteborg, 411 18, Sweden
Completed
Oslo, 0407, Norway
Completed
Trondheim, 7006, Norway
Completed
Sellebakk, 1653, Norway
Completed
Trondheim, 7014, Norway
Completed
Pisek, 39701, Czech Republic
Completed
Ceske Budejovice, 370 01, Czech Republic
Completed
Hradec Kralove, 500 05, Czech Republic
Terminated
Bern, 3010, Switzerland
Completed
Espoo, 02100, Finland
Completed
Kuopio, 70110, Finland
Completed
Helsinki, 00260, Finland
Completed
Joensuu, 80100, Finland
Completed
Stara Zagora, 6000, Bulgaria
Completed
Aravaca, 28023, Spain
Terminated
Barcelona, 08028, Spain
Completed
Sevilla, 41014, Spain
Completed
Pleven, 5800, Bulgaria
Completed
Sofia, 1797, Bulgaria
Completed
Sofia, 1504, Bulgaria
Completed
Sofia, 1606, Bulgaria
Completed
Karlsruhe, 76199, Germany
Completed
Blankenburg, 38889, Germany
Completed
Bernburg, 06406, Germany
Completed
Berlin, 12200, Germany
Completed
Valencia, 46017, Spain
Completed
LEUVEN, 3000, Belgium
Completed
BRUXELLES - BRUSSEL, 1200, Belgium
Completed
LIEGE, 4000, Belgium
Completed
CHARLEROI, 6000, Belgium
Completed
Praha 2, 12808, Czech Republic
Completed
Hamilton, L8S 4K1, Canada
Completed
Ottawa, K1H 7W9, Canada
Completed
Winnipeg, R3T 2E8, Canada
Terminated
Pointe-Claire, H9R 4S3, Canada
Completed
Quebec, G1S 2L6, Canada
Completed
Seattle, 98105, United States
Completed
Tucson, 85712, United States
Completed
Philadelphia, 19114, United States
Completed
San Diego, 92108, United States
Completed
Moorestown, 08057, United States
Completed
Houston, 77054, United States
Completed
Denver, 80209, United States
Completed
New Brunswick, 08901, United States
Completed
Neptune, 07753, United States
Completed
Cleveland, 44195, United States
Completed
San Diego, 92103, United States
Completed
Lincoln, 68510, United States
Completed
Erlangen, 91054, Germany
Terminated
Ilsede, 31241, Germany
Terminated
Lübeck, 23538, Germany
Completed
Southington, 06489, United States
Completed
Norfolk, 23507, United States
Completed
Szentes, 6600, Hungary
Completed
Szeged, 6725, Hungary
Completed
Debrecen, 4032, Hungary
Completed
Portland, 97239-3011, United States
Completed
New York, 10038, United States
Completed
Sapporo, 004-0052, Japan
Completed
Sapporo, 064-0808, Japan
Completed
Kita, 115-0053, Japan
Completed
Kanazawa, 920-8530, Japan
Completed
Omura, 856-8562, Japan
Completed
Tacchikawa, 190-8531, Japan
Completed
Nagano, 381-8551, Japan
Completed
Iizuka, 820-8505, Japan
Completed
Numazu, 410-8555, Japan
Completed
Washington, 20036, United States
Terminated
Pittsburgh, 15213-3180, United States
Completed
Jacksonville, 32207, United States
Completed
Pittsburgh, 15206, United States
Completed
Marrero, 70072, United States
Completed
Örebro, 701 85, Sweden
Completed
Philadelphia, 19104, United States
Completed
Kumamoto, 862-8505, Japan
Completed
Gainesville, 32606, United States
Completed
Nakano-ku, 164-8541, Japan
Completed
Matsudo, 270-2267, Japan
Completed
Koriyama, 963-8585, Japan
Completed
South Miami, 33143, United States
Completed
Geseke, 59590, Germany
Completed
Dresden, 01307, Germany
Completed
Sevilla, 41013, Spain
Completed
Barcelona, 08035, Spain
Completed
Praha, 13000, Czech Republic
Completed
Houston, 77030, United States
Completed
Columbus, 43231, United States
Completed
Frisco, 75035, United States
Completed
Durham, 27713, United States
Completed
Oulu, 90100, Finland
Completed
Olomouc, 772 00, Czech Republic
Completed
BRUXELLES - BRUSSEL, 1070, Belgium
Completed
Kecskemet, 6000, Hungary
Completed
Debrecen, 4024, Hungary
Completed
Newburgh, 47630, United States
Completed
Mesa, 85209, United States
Completed
Naperville, 60540, United States
Completed
Dallas, 75231, United States
Completed
Chattanooga, 37404, United States
Completed
Raleigh, 27612, United States
Completed
Sandy Springs, 30328, United States
Completed
Nesttun, 5221, Norway
Terminated
Plantation, 33324, United States

Primary Outcome

  • Percentage of subjects with amenorrhea, defined as no scheduled or unscheduled bleeding/spotting after the end of the initial bleeding episode until end of treatment
    Amenorrhea was defined as no scheduled or unscheduled bleeding/spotting after the end of the initial bleeding episode until end of treatment. Dose-response curve was estimated based on the primary endpoint. The 4 parameters characterizing the dose-response curve were reported in other pre-specified endpoints below.
    date_rangeTime Frame:
    After end of the initial bleeding episode until the end of treatment, up to 12 weeks

Secondary Outcome

  • Change in volume of menstrual blood loss per 28 days from baseline during treatment by reference period (assessed by Alkaline Hematin method)
    In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint for each arm, respectively.
    date_rangeTime Frame:
    From baseline to end of follow-up
  • Time to onset of controlled bleeding
    Onset of controlled bleeding was defined by the first day, for which the MBL (assessed by MP, Version 2014) for all subsequent 28-day periods up to the end of the treatment period was less than 80 mL. Kaplan-Meier estimated time to onset of controlled bleeding (days) was reported.
    date_rangeTime Frame:
    During treatment period
  • Change in volume of largest fibroid compared to baseline measured by MRI
    Pelvic Magnetic resonance imagings (MRI), without contrast agents, were performed for volume measurements of the uterus and fibroids preferably using 1.5 Tesla scanners or higher. Images were sent to the imaging core laboratory for evaluation. Volume measurements of the uterus and fibroids were performed centrally by independent radiologist(s).
    date_rangeTime Frame:
    From baseline to end of follow-up period

Trial design

A randomized, parallel-group, double-blind, placebo controlled, multi-center study to assess the efficacy and safety of different doses of BAY1002670 in subjects with uterine fibroids over 3 months
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
5

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find information about studies related to Bayer Healthcare products conducted in EuropeClick here to find results for studies related to Bayer Healthcare products.