Leiomyoma MedDRA version: 21.1 Level: LLT Classification code 10016628 Term: Fibroids System Organ Class: 100000004864 MedDRA version: 21.1 Level: LLT Classification code 10046784 Term: Uterine fibroids System Organ Class: 100000004864 MedDRA version: 21.1 Level: LLT Classification code 10022794 Term: Intramural leiomyoma of uterus System Organ Class: 100000004864
Conditions
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women, 18 years or older in good General health 2. 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 3. Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the Screening period each with blood loss volume of >80.00 mL documented by alkaline hematin (AH) method 4. An endometrial biopsy performed during the Screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology 5. Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) 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 260 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 month 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. Laboratory values outside inclusion range before randomization and considered as clinically relevant. 5. 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 6. Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results 7. Abuse of alcohol, drugs, or medicines (eg, laxatives) 8. Use of other treatments that might interfere with the conduct of the study or the interpretation of the results 9. Undiagnosed abnormal genital bleeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo;Secondary Objective: The secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids;Primary end point(s): Amenorrhea (yes/no), defined as menstrual blood loss (MBL) <2 mL during the last 28 days of treatment;Timepoint(s) of evaluation of this end point: The last 28 days of treatment period 1 and treatment period 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. HMB response defined as blood loss 50% reduction compared to baseline 2. Time to onset of amenorrhea. Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2 mL 3. Time to onset of controlled bleeding. Onset of controlled bleeding is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <80.00 mL 4. Absence of bleeding (spotting allowed) during the last 28 days of the treatment; based on the UF-DBD 5. Endometrial histology (e.g. benign endometrium, presence or absence of hyperplasia or malignancy) 6. Endometrial thickness;Timepoint(s) of evaluation of this end point: 1. The last 28 days of treatment period 1 and treatment period 2 2. In treatment period 1and in treatment period 2 3. In treatment period 1 and in treatment period 2 4. The last 28 days of treatment period 1 and treatment period 2 5. Up to 36 weeks 6. Up to 36 weeks | — |
Countries
Bulgaria, China, Czech Republic, Israel, Malaysia, New Zealand, Singapore, South Africa, United States
Contacts
Public ContactBayer Clinical Trial Contact
Bayer AG
Outcome results
None listed