Women, 18 to 50 years old, with uterine fibroids documented by transvaginal or abdominal ultrasound at screening with at least 1 uterine fibroid with largest diameter >=3.0 cm and heavy menstrual bleeding >80 mL will be eligible for enrollment in the study. MedDRA version: 16.1 Level: LLT Classification code 10046784 Term: Uterine fibroids System Organ Class: 100000004864 MedDRA version: 16.1 Level: LLT Classification code 10016628 Term: Fibroids System Organ Class: 100000004864 MedDRA versio
Conditions
Interventions
Product Name: BAY 1002670 coated tablet 0.5 mg 242
Product Code: BAY1002670
Pharmaceutical Form: Coated tablet
INN or Proposed INN: vilaprisan
Current Sponsor code: BAY 1002670
Other descriptive name:
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent 2. Diagnosis of uterine fibroid(s) documented by transvaginal or abdominal ultrasound at screening with at least 1 fibroid with largest diameter >=3.0 cm 3. 18 to 50 years of age at the time of screening 4. Heavy menstrual bleeding >80 mL documented by MP during the bleeding episode following the screening visit 5. Normal or clinically insignificant cervical smear not requiring further follow-up 6. An endometrial biopsy performed at the screening visit 1 (Visit 1), without significant histological disorder such as endometrial hyperplasia or other significant endometrial pathology 7. 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 8. Good general health (except for findings related to uterine fibroids) 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 300 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 2. Uterine fibroid with largest diameter >10.0 cm 3. Hypersensitivity to any ingredient of the study drug 4. Laboratory values outside inclusion range before randomization and considered as clinically relevant 5. Hemoglobin values <6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values <10.9 g/dL will receive iron supplementation) 6. 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 7. Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results 8. Abuse of alcohol, drugs, or medicines 9. Use of other treatments that might interfere with the conduct of the study or the interpretation of the results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the dose-response relationship of BAY 1002670 in subjects with uterine fibroids. ;Secondary Objective: To evaluate the safety of different doses of BAY 1002670 in subjects with uterine fibroids. To establish a population pharmacokinetic/pharmacodynamic relationship for BAY 1002670 in subjects with uterine fibroids. To assess the interchangeability of menstrual pictogram and alkaline hematin method for judgment of menstrual blood loss.;Primary end point(s): Amenorrhea (yes/no) ;Timepoint(s) of evaluation of this end point: After end of the initial bleeding episode until the end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Volume of menstrual blood loss per 28 days (assessed by Alkaline Hematin method) 2. Time to onset of controlled bleeding 3. Percent change in volume of largest fibroid compared to baseline;Timepoint(s) of evaluation of this end point: 1. during treatment and follow-up 2. during treatment 3. end of treatment versus baseline | — |
Countries
Belgium, Bulgaria, Canada, Czech Republic, Finland, Germany, Hungary, Japan, Norway, Spain, Sweden, United States
Contacts
Public ContactBayer Clinical Trials Contact
Bayer HealthCare AG
Outcome results
None listed