Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–50
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
