Women, 18 years or older, diagnosis of uterine fibroid(s) documented by ultrasound at screening and/or during a uterine preserving procedure within 3 months prior to screening in subjects with high risk for recurrence, at least one symptom of uterine fibroid(s) - bleeding, pelvic pressure/pain, good general health, normal or clinically insignificant cervical smear and an endometrial biopsy performed during the screening period without significant histologic disorder MedDRA version: 21.1 Level:
Conditions
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent 2. 18 years or older 3.Diagnosis of uterine fibroid(s) documented by ultrasound at screening AND/OR during a uterine preserving procedure within 3 months prior to screening in subjects with high risk for recurrence 4. At least one symptom of uterine fibroid(s) - bleeding, pelvic pressure/pain 5. Good general health 6. Normal or clinically insignificant cervical smear 7. An endometrial biopsy performed during the screening period, without significant histological disorder 8.Use of an acceptable nonhormonal method of contraception starting at Visit 1 until the end of the study 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 1302 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 drug 3. Any condition requiring immediate blood transfusion 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. Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results 6. Abuse of alcohol, drugs, or medicines (eg, laxatives) 7. Use of other treatments that might interfere with the conduct of the study or the interpretation of the results 8. Undiagnosed abnormal genital bleeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the safety of vilaprisan in subjects with uterine fibroids in comparison to nonhormonal medical treatment in accordance with local standard of care;Secondary Objective: The secondary objective of this study is to evaluate the efficacy of vilaprisan in subjects with uterine fibroids in comparison to nonhormonal medical treatment in accordance with local standard of care.;Primary end point(s): Percentage of change in bone mineral density (BMD) of lumbar spine ;Timepoint(s) of evaluation of this end point: one year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of bleeding days ;Timepoint(s) of evaluation of this end point: Approximately 1 year for subgroup 1 and approximately 2 years for subgroup 2 | — |
Countries
China, Colombia, Czechia, Czech Republic, Finland, Hong Kong, Japan, Mexico, Norway, Poland, Russian Federation, South Africa, Spain, Thailand, Turkey, United States
Contacts
Public ContactBayer Clinical Trial Contact
Bayer AG
Outcome results
None listed