Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)
- Registration Number
- NCT03400956
- Lead Sponsor
- Bayer
- Brief Summary
The primary objective of this study was to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) 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
- 103
- 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 more than 30 mm and less than 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 the 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 months since delivery, abortion, or lactation before start of treatment)
- Hypersensitivity to any ingredient of the study drug
- 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
- 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 (e.g. laxatives)
- Use of other treatments that might interfere with the conduct of the study or the interpretation of results
- Undiagnosed abnormal genital bleeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vilaprisan+Placebo (B2) Vilaprisan (BAY1002670) Vilaprisan 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 in treatment period 2 for 12 weeks, separated by 1 bleeding episode. Vilaprisan (A1) Vilaprisan (BAY1002670) Vilaprisan in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode. Placebo+Vilaprisan (B1) Vilaprisan (BAY1002670) Placebo in treatment period 1 for 12 weeks, and vilaprisan in treatment period 2 for 12 weeks, separated by 1 bleeding episode. Vilaprisan+Placebo (B2) Placebo Vilaprisan in treatment period 1 for 12 weeks, and placebo 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. The evaluation of MBL was based on 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 was defined as MBL \<80.00 mL during the last 28 days of treatment and \>50% reduction compared to baseline (assessed by the AH method).
Number of Participants by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) Up to 36 weeks Number of participants with endometrial histology findings, e.g. benign endometrium, malignant neoplasm, hyperplasia without atypia, hyperplasia with atypia and endometrial polyps.
Change From Baseline of Endometrial Thickness In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks) 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 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 and assessed by the AH method).
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 (assessed by the 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 UF-DBD (Uterine Fibroid Daily Bleeding Diary).
Trial Locations
- Locations (85)
Zaporizhzhia Regional Clinical Hospital
🇺🇦Zaporizhzhya, Ukraine
Matsudo City General Hospital
🇯🇵Matsudo, Chiba, Japan
Tokeidai Memorial Clinic
🇯🇵Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital
🇯🇵Kobe, Hyogo, Japan
Ena Odori Clinic
🇯🇵Sapporo, Hokkaido, Japan
Shonan Fujisawa Tokushukai Hospital
🇯🇵Fujisawa, Kanagawa, Japan
Asahi-Clinic.
🇯🇵Takamatsu, Kagawa, Japan
Saiseikai Fukuoka General Hospital
🇯🇵Fukuoka, Japan
Unoki Clinic
🇯🇵Kagoshima, Japan
Tetsu-Nakamura Obstetrics and Gynecology Internal Medicine
🇯🇵Kagoshima, Japan
Osaka City Hospital Organization Osaka City General Hospital
🇯🇵Osaka, Japan
Smolensk State Medical University
🇷🇺Smolensk, Russian Federation
Vinnytsia City Clinical Maternity Hospital No 2
🇺🇦Vinnytsia, Ukraine
Scien. Res. Institute of Obsterics, Gyn. & Reproduction
🇷🇺St. Petersburg, Russian Federation
Japanese Red Cross Kyoto Daini Hospital
🇯🇵Kyoto, Japan
Medical Co. LEADING GIRLS Women's Clinic LUNA Shinsaibashi
🇯🇵Osaka, Japan
Altai State Medical University
🇷🇺Barnaul, Russian Federation
Maternity Hospital, 17
🇷🇺Saint-Petersburg, Russian Federation
Close Joint Stock Company "Medical Company IDK"
🇷🇺Samara, Russian Federation
Med Estetic Center
🇷🇺St. Petersburg, Russian Federation
Yoshio Clinic
🇯🇵Sapporo, Hokkaido, Japan
Grossmont Center for Clinical Research
🇺🇸La Mesa, California, United States
A Premier Medical Research of Florida, LLC
🇺🇸Orange City, Florida, United States
West Coast OB/GYN Associates
🇺🇸La Mesa, California, United States
National Research Institute
🇺🇸Panorama City, California, United States
Solutions Through Advanced Research, Inc.
🇺🇸Jacksonville, Florida, United States
Health Awareness, Inc.
🇺🇸Jupiter, Florida, United States
Journey Medical Research
🇺🇸Snellville, Georgia, United States
The Clinical Trial Center, LLC
🇺🇸Jenkintown, Pennsylvania, United States
Gynekologicka ambulance - Zabreh na Morave
🇨🇿Zabreh Na Morave, Czechia
DMI Research
🇺🇸Pinellas Park, Florida, United States
Tidewater Physicians for Women
🇺🇸Norfolk, Virginia, United States
Four Seasons Ladies' Clinic
🇯🇵Kumamoto, Japan
GynPorCentrum s.r.o.
🇨🇿Krnov, Czechia
Privatni gynekologicko-porodnicka ordinace
🇨🇿Praha, Czechia
Women's Medical Research Group, LLC
🇺🇸Clearwater, Florida, United States
Vital Pharma Research
🇺🇸Hialeah, Florida, United States
Physician Care Clinical Research
🇺🇸Sarasota, Florida, United States
Unified Women's Clinical Research
🇺🇸Greensboro, North Carolina, United States
Advances in Health, Inc.
🇺🇸Houston, Texas, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Suncoast Research Group, LLC
🇺🇸Miami, Florida, United States
Miami Dade Medical Research Institute, LLC
🇺🇸Miami, Florida, United States
Vista Health Research
🇺🇸Miami, Florida, United States
Advanced Pharma CR, LLC
🇺🇸Miami, Florida, United States
Genoma Research Group, Inc.
🇺🇸Miami, Florida, United States
Florida Research Center, Inc.
🇺🇸Miami, Florida, United States
Clearview Medical Research, LLC
🇺🇸Canyon Country, California, United States
Diagnamics, Inc.
🇺🇸Encinitas, California, United States
South Florida Clinical Research Institute
🇺🇸Margate, Florida, United States
Savin Medical Group LLC
🇺🇸Miami Lakes, Florida, United States
Gynekologie MUDr. Jaromir Karban s.r.o
🇨🇿Neratovice, Czechia
GYNEVI s.r.o.
🇨🇿Rokycany, Czechia
Hashimoto Clinic
🇯🇵Sapporo, Hokkaido, Japan
Kagawa Prefectural Central Hospital
🇯🇵Takamatsu, Kagawa, Japan
Medical Topia Soka Hospital
🇯🇵Soka, Saitama, Japan
Japanese Red Cross Kumamoto Hospital
🇯🇵Kumamoto, Japan
Ijinkai Takeda General Hospital
🇯🇵Kyoto, Japan
Gokeikai Osaka Kaisei Hospital
🇯🇵Osaka, Japan
"Granti-Med"
🇷🇺St. Petersburg, Russian Federation
Chernivtsi Regional Perinatal Center
🇺🇦Chernivtsi, Ukraine
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Palmetto Professional Research
🇺🇸Miami, Florida, United States
Oviedo Medical Research, LLC
🇺🇸Oviedo, Florida, United States
New England Center for Clinical Research, Inc.
🇺🇸Fall River, Massachusetts, United States
Gadolin Research
🇺🇸Beaumont, Texas, United States
Discovery Clinical Trials
🇺🇸San Antonio, Texas, United States
Center of Reproductive Medicine
🇺🇸Webster, Texas, United States
Seattle Clinical Research Center
🇺🇸Seattle, Washington, United States
PMG Research of Wilmington
🇺🇸Wilmington, North Carolina, United States
Vista Clinical Research
🇺🇸Columbia, South Carolina, United States
Altea Research Institute
🇺🇸Las Vegas, Nevada, United States
Women's Healthcare Associates, PA
🇺🇸Idaho Falls, Idaho, United States
Chattanooga Women for Women
🇺🇸Hixson, Tennessee, United States
Funabashi Municipal Medical Center
🇯🇵Funabashi, Chiba, Japan
Tsujinaka Hospital Kashiwanoha
🇯🇵Kashiwa, Chiba, Japan
Kosumo Clinic
🇯🇵Kako-gun, Hyogo, Japan
Kyoto city Hospital
🇯🇵Nakagyo-ku, Kyoto, Japan
Omi Medical Center
🇯🇵Kusatsu, Shiga, Japan
Takamatsu Red Cross Hospital
🇯🇵Takamatsu, Kagawa, Japan
Women Partners in Health Obstetrics & Gynecology (OB/GYN)
🇺🇸Austin, Texas, United States
Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare
🇺🇸Orlando, Florida, United States
Unified Women's Clinical Research / Ocala, FL
🇺🇸Winston-Salem, North Carolina, United States