Leiomyoma MedDRA version: 20.0 Level: LLT Classification code 10046784 Term: Uterine fibroids System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10016628 Term: Fibroids System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code
Conditions
Interventions
Product Name: BAY 1002670 coated tablet 2 mg 245
Product Code: BAY 1002670
Pharmaceutical Form: Coated tablet
INN or Proposed INN: vilaprisan
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women, 18 years or older at the time of Visit 1 2. Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter more than 30 mm and less than 120 mm 3. Heavy menstrual bleeding (HMB) >80.0 mL documented by menstrual pictogram (MP) in a bleeding episode period during the screening period 4.Use of an acceptable non-hormonal method of contraception 5. An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment) 2. Hypersensitivity to any ingredient of the study drugs 3. Hemoglobin values = 6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values =10.9 g/dL will be recommended to use iron supplementation). 4. Any diseases, conditions, or medications 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 5. Abuse of alcohol, drugs, or medicines (eg, laxatives) 6. Undiagnosed abnormal genital bleeding 7. Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to describe the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal.;Secondary Objective: The secondary objective of this study is to evaluate the efficacy and safety of different treatment regimens of vilaprisan in subjects with uterine fibroids.;Primary end point(s): Amenorrhea (yes/no), defined as menstrual blood loss (MBL) < 2 mL based on the menstrual pictogram (MP) during last 28 days ;Timepoint(s) of evaluation of this end point: For the primary analysis of the primary variable, the amenorrhea rates after 12 weeks of treatment in Groups A1, A2 and A3 will be compared to the rate from Group B . | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Total volume of menstrual blood loss (assessed by MP). 2) Number of bleeding days 3) Amenorrhea (yes/no) 4) Absence of bleeding (spotting allowed) 5) Time to onset of controlled bleeding 6) HMB responder rate 7) Percent change in volume of largest fibroid compared to baseline (measured by MRI) ; Timepoint(s) of evaluation of this end point: 1) Menstrual blood loss: from Day 1 of the TP1 until the day before a new TP would start again following the last treatment period 2) Number of bleeding days: from Day 1 of the TP1 until the day before a new TP would start again following the last treatment period 3) Amenorrhea (yes/no), defined as MBL < 2 mL during last 28 days of each TP 4) Absence of bleeding during the last 28 days of the treatment 5) Time to onset of controlled bleeding: the first day, for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is less than 80mL. 6) HMB responder rate (Percentage of subjects with blood loss < 80mL per 28 days and 50% reduction compared to baseline 7) Percent change in volume of largest fibroid compared to baseline | — |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Korea, Republic of, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden, Taiwan, Ukraine, United Kingdom
Contacts
Public ContactBayer Clinical Trials Contact
Bayer AG
Outcome results
None listed