Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)
- Registration Number
- NCT03400943
- Lead Sponsor
- Bayer
- Brief Summary
The primary objective of this study was to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo.
The secondary objectives of this study were to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 93
- Women, 18 years or older in good General health
- Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest Diameter ≥ 30 mm and < 120 mm
- 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
- An endometrial biopsy performed during the Screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology
- 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
- Pregnancy or lactation (less than 3 month since delivery, abortion, or lactation before start of Treatment)
- Hypersensitivity to any ingredient of the study drug
- Any condition requiring immediate blood transfusion
- Laboratory values outside inclusion range before randomization and considered as clinically relevant.
- 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 (eg, laxatives)
- Use of other treatments that might interfere with the conduct of the study or the interpretation of the results
- Undiagnosed abnormal genital bleeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vilaprisan (A2) Vilaprisan (BAY1002670) Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break. Placebo+Vilaprisan (B1) Vilaprisan (BAY1002670) Placebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode. Vilaprisan (A1) Placebo Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode. Vilaprisan (A1) Vilaprisan (BAY1002670) Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode. Vilaprisan+Placebo (B2) Placebo Vilaprisan (2 mg) in treatment period 1 for 12 weeks and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode. Vilaprisan+Placebo (B2) Vilaprisan (BAY1002670) Vilaprisan (2 mg) in treatment period 1 for 12 weeks and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode. Placebo+Vilaprisan (B1) Placebo Placebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
- Primary Outcome Measures
Name Time Method Number of Participants With Amenorrhea The last 28 days of treatment period 1 Amenorrhea was defined as menstrual blood loss (MBL) \<2 mL during the last 28 days of treatment measured by the alkaline hematin (AH) method.
- Secondary Outcome Measures
Name Time Method Number of Participants With Heavy Menstrual Bleeding (HMB) Response The last 28 days of treatment period 1 and treatment period 2 HMB response was defined as MBL \<80 mL during the last 28 days of treatment and \>50% reduction from baseline based on AH-method.
Time to Onset of Amenorrhea In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks) Onset of amenorrhea was defined by the first day for which the MBL for all subsequent 28-day periods up to the end of a treatment period was \< 2 mL (amenorrhea defined similar to primary endpoint).
Time to Onset of Controlled Bleeding In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks) Onset of controlled bleeding was defined by the first day for which the MBL for all subsequent 28-day periods up to the end of a treatment period was \<80.00 mL based on AH-method.
Number of Participants With Absence of Bleeding (Spotting Allowed) The last 28 days of treatment period 1 and treatment period 2 Absence of bleeding was defined as no scheduled or unscheduled bleeding (spotting allowed) during the last 28 days of a treatment period based on subjects' daily responses to the Uterine Fibroid Daily Bleeding Diary (UF-DBD).
Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) Up to 2 weeks after end of treatment Number of participants with endometrial histology findings, e.g. benign endometrium, Malignant Neoplasm, Hyperplasia WHO 2014, no atypia or Hyperplasia WHO 2014, atypia and Endometrial Polyps.
Change From Baseline of Endometrial Thickness Treatment phase (up to 2 weeks after end of treatment) and follow-up phase (starts on the day after the end of the treatment until the last study visit [up to approximately 2 years]) Ultrasound examinations were performed. Endometrial thickness was measured in the medio-sagittal section as double-layer in millimeters. Summary statistics for change from baseline in endometrial thickness was provided in below table.
Trial Locations
- Locations (103)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
California Center for Clinical Research
🇺🇸Arcadia, California, United States
Core Healthcare Group
🇺🇸Cerritos, California, United States
AVIVA Research
🇺🇸Escondido, California, United States
National Research Institute - Los Angeles
🇺🇸Los Angeles, California, United States
Harbor - UCLA Medical Center
🇺🇸Torrance, California, United States
Ideal Clinical Research
🇺🇸Aventura, Florida, United States
South Florida Medical Research
🇺🇸Aventura, Florida, United States
Helix Biomedics, LLC
🇺🇸Boynton Beach, Florida, United States
Dr. Victoria Garcia & Associates, LLC Doral Medical Research
🇺🇸Doral, Florida, United States
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