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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
93
2 mg of Vilaprisan once daily up to 2 x 12 weeks
Matching placebo was administered to group B1 and B2.
Number of Participants With Amenorrhea
Amenorrhea was defined as menstrual blood loss (MBL) \<2 mL during the last 28 days of treatment measured by the alkaline hematin (AH) method.
Time frame: The last 28 days of treatment period 1
Number of Participants With Heavy Menstrual Bleeding (HMB) Response
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 frame: The last 28 days of treatment period 1 and treatment period 2
Time to Onset of Amenorrhea
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 frame: In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)
Time to Onset of Controlled Bleeding
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.
Time frame: In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)
Number of Participants With Absence of Bleeding (Spotting Allowed)
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).
Time frame: The last 28 days of treatment period 1 and treatment period 2
Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
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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
...and 93 more locations
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.
Time frame: Up to 2 weeks after end of treatment
Change From Baseline of Endometrial Thickness
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.
Time frame: 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])