stop_circleTerminated/Withdrawn
Uterine fibroids
Bayer Identifier:
15790
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine Fibroids (ASTEROID 4)
Trial purpose
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
The secondary objectives of this study were to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids
Key Participants Requirements
Sex
FemaleAge
18 - N/ATrial summary
Enrollment Goal
103Trial Dates
January 2018 - June 2021Phase
Phase 3Could I Receive a placebo
YesProducts
Vilaprisan (BAY1002670)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Advances in Health, Inc. | Houston, 77030, United States |
Completed | Savin Medical Group LLC | Miami Lakes, 33014, United States |
Completed | Grossmont Center for Clinical Research | La Mesa, 91942, United States |
Completed | Physician Care Clinical Research | Sarasota, 34239, United States |
Completed | Solutions Through Advanced Research, Inc. | Jacksonville, 32256, United States |
Completed | DMI Research | Pinellas Park, 33782, United States |
Completed | Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare | Orlando, 32801, United States |
Completed | PMG Research of Wilmington | Wilmington, 28401, United States |
Completed | Vista Clinical Research | Columbia, 29201, United States |
Completed | Women's Medical Research Group, LLC | Clearwater, 33759, United States |
Completed | Seattle Clinical Research Center | Seattle, 98105, United States |
Completed | Unified Women's Clinical Research / Ocala, FL | Winston-Salem, 27103, United States |
Completed | Vista Health Research | Miami, 33176, United States |
Completed | Palmetto Professional Research | Miami, 33186, United States |
Completed | Clearview Medical Research, LLC | Canyon Country, 91351, United States |
Completed | Diagnamics, Inc. | Encinitas, 92024, United States |
Completed | Oviedo Medical Research, LLC | Oviedo, 32765, United States |
Withdrawn | Women's Health Practice | Champaign, 61820, United States |
Completed | Journey Medical Research | Snellville, 30078, United States |
Withdrawn | University of Cincinnati | Cincinnati, 45267, United States |
Completed | Unified Women’s Clinical Research | Greensboro, 27408, United States |
Completed | Miami Dade Medical Research Institute, LLC | Miami, 33176, United States |
Completed | University of Pennsylvania | Philadelphia, 19104, United States |
Completed | New England Center for Clinical Research, Inc. | Fall River, 02720, United States |
Completed | The Clinical Trial Center, LLC | Jenkintown, 19046, United States |
Completed | Altea Research Institute | Las Vegas, 89102, United States |
Completed | Women's Healthcare Associates, PA | Idaho Falls, 83404, United States |
Completed | Chattanooga Women for Women | Hixson, 37343, United States |
Completed | Discovery Clinical Trials | Dallas, 75231, United States |
Completed | Vital Pharma Research | Hialeah, 33016, United States |
Completed | Discovery Clinical Trials | San Antonio, 78258, United States |
Completed | Medical Center for Clinical Research | San Diego, 92108, United States |
Completed | Health Awareness, Inc. | Jupiter, 33458, United States |
Completed | A Premier Medical Research of Florida, LLC | Orange City, 32763, United States |
Completed | Artemis Institute for Clinical Research | San Diego, 92103, United States |
Withdrawn | Cleveland Clinic | Cleveland, 44195, United States |
Withdrawn | Amy Brenner, MD & Associates, LLC | Mason, 45040, United States |
Completed | Gynekologicka ambulance - Zabreh na Morave | Zabreh na Morave, 78901, Czechia |
Completed | Gynekologie MUDr. Jaromir Karban s.r.o | Neratovice, 277 11, Czechia |
Completed | Privatni gynekologicko-porodnicka ordinace | Praha, 16000, Czechia |
Completed | GYNEVI s.r.o. | Rokycany, 337 01, Czechia |
Completed | GynPorCentrum s.r.o. | Krnov, 794 01, Czechia |
Completed | Center of Reproductive Medicine | Webster, 77598, United States |
Withdrawn | Northwestern University | Chicago, 60611, United States |
Completed | Suncoast Research Group, LLC | Miami, 33135, United States |
Completed | Tidewater Physicians for Women | Norfolk, 23502, United States |
Completed | Oregon Health and Science University | Portland, 97239-3011, United States |
Completed | Genoma Research Group, Inc. | Miami, 33165, United States |
Completed | South Florida Clinical Research Institute | Margate, 33073, United States |
Completed | Florida Research Center, Inc. | Miami, 33174, United States |
Completed | Advanced Pharma CR, LLC | Miami, 33147, United States |
Completed | National Research Institute | Huntington Park, 90255, United States |
Completed | Gadolin Research | Beaumont, 77702, United States |
Completed | West Coast OB/GYN Associates | LA Mesa, 91942, United States |
Completed | Smolensk State Medical University | Smolensk, 214019, Russian Federation |
Withdrawn | Regional Clinical Hospital #2 | Krasnodar, 350012, Russian Federation |
Completed | Med Estetic Center | St. Petersburg, 192177, Russian Federation |
Completed | Close Joint Stock Company "Medical Company IDK" | Samara, 443067, Russian Federation |
Completed | Maternity Hospital, 17 | Saint-Petersburg, 192174, Russian Federation |
Completed | "Granti-Med" | St. Petersburg, 198329, Russian Federation |
Completed | Scien. Res. Institute of Obsterics, Gyn. & Reproduction | St. Petersburg, 199034, Russian Federation |
Completed | Altai State Medical University | Barnaul, 656038, Russian Federation |
Completed | Vinnytsia City Clinical Maternity Hospital No 2 | Vinnytsia, 21001, Ukraine |
Completed | Chernivtsi Regional Perinatal Center | Chernivtsi, 58001, Ukraine |
Completed | Zaporizhzhia Regional Clinical Hospital | Zaporizhzhya, 69103, Ukraine |
Withdrawn | Spitalul Clinic Nicolae Malaxa | Bucuresti, 022448, Romania |
Withdrawn | S.C. Centrul Medical Euromed S.R.L | Bucuresti, 020762, Romania |
Withdrawn | S.C. Quantum Medical Center S.R.L | Bucuresti, 012071, Romania |
Withdrawn | S.C. Centrul Medical de Diagn si Tratam Ambulator Neomed SRL | Brasov, 500283, Romania |
Withdrawn | S.C. SANADOR SRL | Bucharest, 011026, Romania |
Withdrawn | Spitalul Clinic Municipal Filantropia Craiova | Craiova, 200143, Romania |
Completed | National Research Institute | Panorama City, 91402, United States |
Completed | Hashimoto Clinic | Sapporo, 004-0052, Japan |
Completed | Yoshio Clinic | Sapporo, 064-0808, Japan |
Completed | Tokeidai Memorial Clinic | Sapporo, 060-0031, Japan |
Completed | Medical Topia Soka Hospital | Soka, 340-0028, Japan |
Completed | Ena Odori Clinic | Sapporo, 060-0001, Japan |
Completed | Kagawa Prefectural Central Hospital | Takamatsu, 760-8557, Japan |
Completed | Unoki Clinic | Kagoshima, 892-0826, Japan |
Completed | Japanese Red Cross Kumamoto Hospital | Kumamoto, 861-8520, Japan |
Completed | Asahi-Clinic. | Takamatsu, 760-0076, Japan |
Completed | Kyoto city Hospital | Nakagyo-ku, 604-8845, Japan |
Completed | Takamatsu Red Cross Hospital | Takamatsu, 760-0017, Japan |
Completed | Gokeikai Osaka Kaisei Hospital | Osaka, 532-0003, Japan |
Completed | Tetsu-Nakamura Obstetrics and Gynecology Internal Medicine | Kagoshima, 892-0845, Japan |
Completed | Matsudo City General Hospital | Matsudo, 270-2296, Japan |
Completed | Osaka City Hospital Organization Osaka City General Hospital | Osaka, 534-0021, Japan |
Completed | Ijinkai Takeda General Hospital | Kyoto, 601-1495, Japan |
Completed | Tsujinaka Hospital Kashiwanoha | Kashiwa, 277-0871, Japan |
Completed | Medical Co. LEADING GIRLS Women's Clinic LUNA Shinsaibashi | Osaka, 542-0086, Japan |
Completed | FOUR SEASONS LADIES’ CLINIC | Kumamoto, 860-0846, Japan |
Completed | Funabashi Municipal Medical Center | Funabashi, 273-8588, Japan |
Completed | Saiseikai Fukuoka General Hospital | Fukuoka, 810-0001, Japan |
Completed | Shonan Fujisawa Tokushukai Hospital | Fujisawa, 251-0041, Japan |
Completed | OMI MEDICAL CENTER | Kusatsu, 525-8585, Japan |
Completed | Women Partners in Health Obstetrics & Gynecology (OB/GYN) | Austin, 78705, United States |
Withdrawn | Central Research Associates, Inc. | Birmingham, 35205, United States |
Completed | Kobe City Medical Center General Hospital | Kobe, 650-0047, Japan |
Completed | Kosumo Clinic | Kako-gun, 675-1115, Japan |
Withdrawn | Nash OB-GYN Associates, P.A. | Rocky Mount, 27804, United States |
Completed | Japanese Red Cross Kyoto Daini Hospital | Kyoto, 602-8026, Japan |
Withdrawn | Great Lakes Research Group, Inc. | Saginaw, 48602, United States |
Withdrawn | United Clinical Research | Huntington Beach, 90255, United States |
Withdrawn | Gynekologie MEDA s.r.o. | Brno, 602 00, Czechia |
Primary Outcome
- Number of participants with amenorrheaAmenorrhea 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.date_rangeTime Frame:The last 28 days of treatment period 1
Secondary Outcome
- Number of participants with heavy Menstrual Bleeding (HMB) responseHMB 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).date_rangeTime Frame:The last 28 days of treatment period 1 and treatment period 2
- Time to onset of amenorrheaOnset 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).date_rangeTime Frame:In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)
- Time to onset of controlled bleedingOnset 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).date_rangeTime 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 UF-DBD (Uterine Fibroid Daily Bleeding Diary).date_rangeTime Frame:The last 28 days of treatment period 1 and treatment period 2
- Number of participants by endometrial biopsy main results (majority read, main diagnosis)Number of participants with endometrial histology findings, e.g. benign endometrium, Malignant Neoplasm, Hyperplasia 2014, no atypia or Hyperplasia 2014, atypia and Endometrial Polyps.date_rangeTime Frame:Up to 36 weeks
- Change from baseline of endometrial thicknessUltrasound 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.date_rangeTime Frame:Up to 36 weeks
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
3