Uterine Fibroids
Conditions
Brief summary
The primary objective of this study is to describe the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal. The secondary objective of this study is to evaluate the efficacy and safety of different treatment regimens of vilaprisan in subjects with uterine fibroids.
Interventions
Orally, 2 mg, once daily
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
With protocol version 5.0 the blinded study arms A3 and B were converted to one open-label study arm called A3/B.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women, 18 years or older at the time of Visit 1 * 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 * Heavy menstrual bleeding (HMB) \>80.00 mL documented by menstrual pictogram (MP) in a bleeding episode period during the screening period * Use of an acceptable non-hormonal method of contraception * An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology
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 drugs * 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) * 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 including * Abuse of alcohol, drugs, or medicines (eg: laxatives) * Undiagnosed abnormal genital bleeding * 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 | Description |
|---|---|---|
| Amenorrhea (yes/no) | At 3 months (at the end of treatment perid 1) | Defined as menstrual blood loss (MBL) \< 2 mL based on the menstrual pictogram (MP) during last 28 days. 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 | Description |
|---|---|---|
| Number of bleeding days | After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2 | From day 1 of the first treatment period until the day before the next treatment period after the last treatment period would start again normalized to 28 days. |
| Amenorrhea (yes/no) | At 6 months, at 12 months, at 15 months, at 18 months, at 21 months and at 24 months | Defined as menstrual blood loss (MBL) \< 2 mL based on the menstrual pictogram (MP) during last 28 days of the treatment period. |
| Absence of bleeding (spotting allowed) | Up to 24 months | Absence of bleeding defined as no bleeding (spotting allowed) during the last 28 days of the treatment; based on the UF-DBD (Uterine Fibroid Daily Symptom Diary). |
| Time to onset of controlled bleeding | Quarterly up to 24 months | Onset of controlled bleeding is defined by the first day, for which the menstrual blood loss (assessed by MP) for all subsequent 28-day periods up to the end of the treatment period is less than 80.00 mL. |
| Total volume of menstrual blood loss | After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2 | Assessed by menstrual pictogram (MP). Volume of menstrual blood loss will be normalized by 28 days. |
| Percent change in volume of largest fibroid compared to baseline | At baseline, at 12 months and at 24 months | Measured by MRI (magnetic resonance imaging). |
| Endometrial histology | Up to 24 months | E.g., benign endometrium, presence or absence of hyperplasia or malignancy |
| Endometrial thickness | Up to 24 months | — |
| HMB (Heavy Menstrual Bleeding) responder rate | By treatment period up to 24 months | Percentage of subjects with blood loss \< 80.00 mL per 28 days and 50% reduction compared to baseline \[assessed by MP\] |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, Finland, Germany, Hungary, Ireland, Italy, Lithuania, Netherlands, Norway, Poland, Portugal, Slovakia, South Korea, Spain, Sweden, Taiwan, United Kingdom
Outcome results
None listed