Uterine Fibroids and Heavy Menstrual Bleeding
Conditions
Brief summary
To evaluate the safety and efficacy of vilaprisan in Japanese subjects with uterine fibroids and heavy menstrual bleeding (HMB).
Interventions
2mg, once daily, oral
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Diagnosis of uterine fibroid(s) documented by ultrasound at screening * Heavy menstrual bleeding (HMB) \>80.00 mL associated with uterine fibroid(s) * Good general health * Normal or clinically insignificant cervical smear * An endometrial biopsy performed during the screening period, without significant histological disorder * Use of an acceptable nonhormonal method of contraception starting at Visit 1 until the end of the study
Exclusion criteria
* Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment) * Hypersensitivity to any ingredient of the study drug * Any condition requiring immediate blood transfusion * 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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse event | Up to one year and 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of bleeding days | Up to one year and 3 months |
Countries
Japan
Outcome results
None listed