stop_circleTerminated/Withdrawn
Uterine fibroids
Bayer Identifier:
15787
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine Fibroids (ASTEROID 3)
Trial purpose
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.
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
93Trial Dates
January 2018 - April 2022Phase
Phase 3Could I Receive a placebo
YesProducts
Vilaprisan (BAY1002670)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Tianjin Medical University General Hospital | Tianjin, 300052, China |
Completed | Beijing Tiantan Hospital, Captial Medical University | Beijing, 100050, China |
Withdrawn | First Teaching Hosptial of Tianjin University of TCM | Tianjin, 300193, China |
Withdrawn | Tianjin Central Hospital of Gynecology obstetrics | Tianjin, 300199, China |
Completed | Clinical Neurosciences Solutions, Inc DBA CNS Healthcare | Memphis, 38119, United States |
Completed | Eastern Carolina Women's Center | New Bern, 28562, United States |
Completed | Unified Women's Clinical Research - Morehead City | Morehead City, 28557, United States |
Completed | Clinical Research of Philadelphia, LLC | Philadelphia, 19114, United States |
Completed | Atlanta Women's Research Institute, Inc. - Alpharetta | Atlanta, 30342, United States |
Completed | Medisense, Inc. | Atlanta, 30363, United States |
Completed | GTC Research | Shawnee, 66218, United States |
Completed | ONCOVA Clinical Research, Inc. | Saint Cloud, 34769, United States |
Completed | PharmaSite Research, Inc. | Baltimore, 21208, United States |
Completed | Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare | Jacksonville, 32256, United States |
Completed | One Health Research Clinic | Norcross, 30093, United States |
Completed | Beijing Hospital of Traditional Chinese Medicine | Beijing, 100010, China |
Completed | The Second Affiliated Hospital of Shanxi Medical University | Taiyuan, 030001, China |
Completed | General Hospital of Ningxia Medical University | Yinchuan, 750004, China |
Completed | Texas Health Care, PLLC | Ft. Worth, 76104, United States |
Completed | Agile Clinical Research Trials, LLC | Atlanta, 30328, United States |
Terminated | Sweet Hope Research Specialty, Inc. - Hialeah | Hialeah, 33016, United States |
Completed | The Second Affliated Hospital of Wenzhou Medicial University | Wenzhou, 325000, China |
Completed | Shengjing Hospital of China Medical University | Shenyang, 110022, China |
Completed | 900th Hospital of Joint Logistics Support Force | Fuzhou, 350025, China |
Completed | Nanjing Maternity and Child Health Care Hospital | Nanjing, 210004, China |
Completed | NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School | Nanjing, 210008, China |
Completed | Wuhan Tongji Reproductive Medicine Hospital | Wuhan, 430013, China |
Withdrawn | West China Second University Hospital | Chengdu, 610066, China |
Completed | The First Hospital of Jilin University | Changchun, 130000, China |
Withdrawn | New Horizons Women's Care | Chandler, 85224, United States |
Completed | Medical University of South Carolina | Charleston, 29425, United States |
Completed | Axcess Medical Research, LLC | Loxahatchee, 33470, United States |
Completed | Accelerated Enrollment Solutions a business of PPD | Orlando, 32808, United States |
Withdrawn | Univ.of South Florida College of Medicine | Tampa, 33606, United States |
Withdrawn | Invocare Clinical Research Center, LLC | West Columbia, 29169, United States |
Completed | Peking University First Hospital | Beijing, 100034, China |
Completed | The First Affiliated Hospital of Dalian Medical University | Dalian, 116011, China |
Completed | Hainan General Hospital | Haikou, 570311, China |
Completed | Women's Hospital School of Medicine Zhejiang University | Hangzhou, 310006, China |
Completed | Sir Run Run Shaw Hospital, Zhejiang University School of Med | Hangzhou, 310016, China |
Completed | The Third Affiliated Hospital, Sun Yat-Sen University | Guangzhou, 510630, China |
Completed | The Second Affiliated Hospital of Nanchang University | Nanchang, 330006, China |
Withdrawn | International Peace Maternity&Child Health Hospital of CWI | Shanghai, 200030, China |
Completed | Jiangxi Maternal and Child Health Hospital | Nanchang, 330006, China |
Withdrawn | MultiCare Health Systems Women's Health Care | Covington, 98042, United States |
Completed | Omni Fertility and Laser Institute | Shreveport, 71118, United States |
Completed | Helix Biomedics, LLC | Boynton Beach, 33435, United States |
Completed | Core Healthcare Group | Cerritos, 90703, United States |
Completed | Synexus Research, LLC | Richmond, 23226, United States |
Completed | The First Affiliated Hospital of Xinjiang Medical University | Urumqi, 830054, China |
Withdrawn | Shanghai First Maternity and Infant Hospital | Shanghai, 200040, China |
Completed | Shanghai East Hospital Affiated to Tongji University | Shanghai, 200123, China |
Completed | SUNY Downstate Medical Center | Brooklyn, 11203, United States |
Completed | Biopharma Informatic, Inc. | Houston, 77043, United States |
Withdrawn | Oklahoma University | Oklahoma City, 73104, United States |
Withdrawn | Dedicated Women's Health Specialists, Inc. | Puyallup, 98372, United States |
Completed | Carolinas Healthcare System | Charlotte, 28204, United States |
Completed | Hospital for Active Treatment - Prof.Paraskev Stoyanov AD | Lovech, 5500, Bulgaria |
Completed | MHAT Dr. Bratan Shukerov AD | Smolyan, 4700, Bulgaria |
Completed | Multiprofile Hospital for Active Treatment-Dr. T. Venkova AD | Gabrovo, 5300, Bulgaria |
Completed | MHAT for Women's Health - Nadezhda OOD | Sofia, 1330, Bulgaria |
Completed | Chattanooga Medical Research, LLC | Chattanooga, 37404, United States |
Withdrawn | Wasatch Clinical Research, LLC | Salt Lake City, 84107, United States |
Withdrawn | Advocate Lutheran | Park Ridge, 60068, United States |
Withdrawn | University of Louisville | Louisville, 40202, United States |
Completed | Houston Center for Clinical Research, LLC | Sugarland, 77479, United States |
Completed | University of Alabama at Birmingham | Birmingham, 35294-0026, United States |
Completed | Dr. Victoria Garcia & Associates, LLC Doral Medical Research | Doral, 33166, United States |
Completed | Discovery Clinical Research | Plantation, 33324, United States |
Withdrawn | The Clinical Research Institute | Hialeah, 33012, United States |
Completed | National Research Institute - Los Angeles | Los Angeles, 90057, United States |
Completed | Georgia Center For Women | Atlanta, 30312, United States |
Completed | The Center for Clinical Trials, Inc. | Houston, 77082, United States |
Withdrawn | Wake Forest Baptist Health | Winston-Salem, 27103, United States |
Withdrawn | Christiana Care Health System | Newark, 10713, United States |
Withdrawn | Serenity Holistic OBGYN | North Miami Beach, 33162, United States |
Completed | South Florida Medical Research | Aventura, 33180, United States |
Completed | Millennium Clinical Trials, LLC | Arlington, 22207, United States |
Completed | Main Line Fertility Center | Bryn Mawr, 19010, United States |
Withdrawn | University of Rochester Medical Center | Rochester, 14623, United States |
Completed | California Center for Clinical Research | Arcadia, 91007, United States |
Withdrawn | Sutter East Bay Medical Center | Berkeley, 94704, United States |
Withdrawn | IU Health University Hospital | Indianapolis, 46202, United States |
Withdrawn | Inova Fairfax Hospital - Falls Church | Falls Church, 22042, United States |
Completed | Dr L Reynders Practice | Lyttelton Manor, 0141, South Africa |
Completed | Umhlanga Medical Centre | Durban, 4319, South Africa |
Completed | Wilgeheuwel Hospital | Roodepoort, 1724, South Africa |
Withdrawn | WITS Clinical Research Site | Johannesburg, 2193, South Africa |
Completed | Ethekwini Hospital & Heart Centre | Durban, South Africa |
Completed | Soukroma gynekologicka ambulance | Fulnek, 74245, Czechia |
Completed | MUDr. Ivana Salamonova s.r.o. | Vysoke Myto, 566 01, Czechia |
Completed | Gynekologie Studentsky dum s.r.o. | Praha 6, 160 00, Czechia |
Completed | Gynekologie MEDA s.r.o. | Brno, 602 00, Czechia |
Completed | Hillel Yaffe Medical Center | Hadera, 3810101, Israel |
Completed | The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an, 710061, China |
Completed | Second Affiliated Hospital of Xi'an Jiaotong University | Xi'an, 710004, China |
Completed | 1st Affiliated hospital of Soochow University | Suzhou, 215006, China |
Withdrawn | National University Hospital | Singapore, 119074, Singapore |
Completed | KK Women's and Children's Hospital | Singapore, 229899, Singapore |
Completed | P3 Research | Tauranga, 3110, New Zealand |
Completed | P3 Research Ltd Hawkes Bay | Hawkes Bay, 4130, New Zealand |
Withdrawn | Rambam Health Corporation | Haifa, 3109601, Israel |
Completed | Family Medicine Clinic | Georgetown, 78626, United States |
Completed | Lady Davis Carmel Medical Center | Haifa, 3436212, Israel |
Completed | Meir Medical Center | Kfar Saba, 4428164, Israel |
Completed | Clalit Health Services through HaEmek Medical Center | Afula, 1834111, Israel |
Withdrawn | Shanghai General Hospital | Shanghai, 200080, China |
Completed | AVIVA Research | Escondido, 92025, United States |
Completed | Advantia Health, LLC Obstetrics & Gynecology Assoc. | Silver Spring, 20910, United States |
Completed | Simmonds, Martin and Helmbrecht | Gaithersburg, 20878, United States |
Completed | Paramount Research Solutions-Nashville | Nashville, 37203, United States |
Withdrawn | Ana Tomayo, MD | Pembroke Pines, 33024, United States |
Completed | Zhongda Hospital Southeast University | Nanjing, 210009, China |
Withdrawn | Nanjing First Hospital | Nanjing, 210006, China |
Completed | University Hospital Kebangsaan Malaysia | Kuala Lumpur, 56000, Malaysia |
Completed | Hospital Wanita dan Kanak-Kanak Sabah | Sabah, 88996, Malaysia |
Completed | Sarawak General Hospital | Sarawak, 93400, Malaysia |
Completed | Ideal Clinical Research | Aventura, 33180, United States |
Completed | Fusion Clinical Research of Spartanburg, LLC | Spartanburg, 29301, United States |
Completed | Boai Hospital of Zhongshan | Zhongshan, China |
Completed | Harbor - UCLA Medical Center | Torrance, 90509-2910, United States |
Withdrawn | Clinical Research Consultants of Altanta, LLC | Suwanee, 30024, United States |
Withdrawn | Brownstone Clinical Trials, LLC | Fort Worth, 76104, United States |
Completed | Ocean Blue Medical Research Center, Inc. | Miami Springs, 33166, United States |
Completed | Guangzhou Women and Children's Medical Center | Guangzhou, 510623, China |
Withdrawn | Asheville Women's Medical Center | Asheville, 28801, United States |
Completed | Beijing Friendship Hospital, Capital Medical University | Beijing, 100050, China |
Completed | Fellows Research Alliance - Savannah | Savannah, 31406, United States |
Completed | Wake Research, Inc. | Raleigh, 27612, United States |
Withdrawn | University of Illinois at Chicago | Department of Neurology | Chicago, 60612, United States |
Completed | Fellows Research Alliance, Inc. | Bluffton, 29910, United States |
Completed | Willowbend Health & Wellness Associates | Frisco, 75035, United States |
Completed | Altus Research | Lake Worth, 33461, United States |
Completed | Paramount Research Solutions-College Park | College Park, 30349, United States |
Completed | Centex Studies, Inc. | Houston, 77058, United States |
Withdrawn | Dolphin Medical Research | Doral, 33172, United States |
Withdrawn | The 2nd Hospital of Hebei Medical University | Shijiazhuang, 050000, China |
Withdrawn | Aventura Clinical Research, LLC | Miramar, 33027, United States |
Withdrawn | The Second Hospital of Jilin University | Changchun, 130000, China |
Withdrawn | The Second Affiliated Hospital of Nanjing Medical university | Nanjing, 210011, China |
Withdrawn | The First Affiliated Hospital of Anhui Medical University | Hefei, 230022, China |
Withdrawn | Lanzhou University Second Hospital | Lanzhou, 730030, China |
Withdrawn | The First Affiliated Hospital of Wenzhou Medical Univ (New) | Wenzhou, 325000, China |
Withdrawn | Beijing Luhe Hospital of Capital Medicial University | Beijing, 101199, China |
Withdrawn | The People's Hospital of Guangxi Zhuang Autonomous Region | Nanning, 530021, China |
Primary Outcome
- Number of participants with amenorrheaAmenorrhea was defined as menstrual blood loss (MBL) <2 mL during the last 28 days of treatment.date_rangeTime Frame:The last 28 days of treatment period 1
Secondary Outcome
- Number of participants with heavy Menstrual Bleeding (HMB) responseHMB response was defined as MBL <80 mL during the last 28 days of treatment and >50% reduction from baseline.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).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.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 Uterine Fibroid Daily Bleeding Diary (UF-DBD).date_rangeTime 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)Number of participants with endometrial histology findings, e.g. benign endometrium, Malignant Neoplasm, Hyperplasia WHO 2014, no atypia or Hyperplasia 2014, atypia and Endometrial Polyps.date_rangeTime Frame:Up to 2 weeks after end of treatment
- 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 2 weeks after end of treatment
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
4