stop_circleTerminated/Withdrawn

Uterine fibroids

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.

Key Participants Requirements

Sex

Female

Age

18 - N/A
  • - 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

Trial summary

Enrollment Goal
93
Trial Dates
January 2018 - April 2022
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Tianjin Medical University General HospitalTianjin, 300052, China
Completed
Beijing Tiantan Hospital, Captial Medical UniversityBeijing, 100050, China
Withdrawn
First Teaching Hosptial of Tianjin University of TCMTianjin, 300193, China
Withdrawn
Tianjin Central Hospital of Gynecology obstetricsTianjin, 300199, China
Completed
Clinical Neurosciences Solutions, Inc DBA CNS HealthcareMemphis, 38119, United States
Completed
Eastern Carolina Women's CenterNew Bern, 28562, United States
Completed
Unified Women's Clinical Research - Morehead CityMorehead City, 28557, United States
Completed
Clinical Research of Philadelphia, LLCPhiladelphia, 19114, United States
Completed
Atlanta Women's Research Institute, Inc. - AlpharettaAtlanta, 30342, United States
Completed
Medisense, Inc.Atlanta, 30363, United States
Completed
GTC ResearchShawnee, 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 HealthcareJacksonville, 32256, United States
Completed
One Health Research ClinicNorcross, 30093, United States
Completed
Beijing Hospital of Traditional Chinese MedicineBeijing, 100010, China
Completed
The Second Affiliated Hospital of Shanxi Medical UniversityTaiyuan, 030001, China
Completed
General Hospital of Ningxia Medical UniversityYinchuan, 750004, China
Completed
Texas Health Care, PLLCFt. Worth, 76104, United States
Completed
Agile Clinical Research Trials, LLCAtlanta, 30328, United States
Terminated
Sweet Hope Research Specialty, Inc. - HialeahHialeah, 33016, United States
Completed
The Second Affliated Hospital of Wenzhou Medicial UniversityWenzhou, 325000, China
Completed
Shengjing Hospital of China Medical UniversityShenyang, 110022, China
Completed
900th Hospital of Joint Logistics Support ForceFuzhou, 350025, China
Completed
Nanjing Maternity and Child Health Care HospitalNanjing, 210004, China
Completed
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med SchoolNanjing, 210008, China
Completed
Wuhan Tongji Reproductive Medicine HospitalWuhan, 430013, China
Withdrawn
West China Second University HospitalChengdu, 610066, China
Completed
The First Hospital of Jilin UniversityChangchun, 130000, China
Withdrawn
New Horizons Women's CareChandler, 85224, United States
Completed
Medical University of South CarolinaCharleston, 29425, United States
Completed
Axcess Medical Research, LLCLoxahatchee, 33470, United States
Completed
Accelerated Enrollment Solutions a business of PPDOrlando, 32808, United States
Withdrawn
Univ.of South Florida College of MedicineTampa, 33606, United States
Withdrawn
Invocare Clinical Research Center, LLCWest Columbia, 29169, United States
Completed
Peking University First HospitalBeijing, 100034, China
Completed
The First Affiliated Hospital of Dalian Medical UniversityDalian, 116011, China
Completed
Hainan General HospitalHaikou, 570311, China
Completed
Women's Hospital School of Medicine Zhejiang UniversityHangzhou, 310006, China
Completed
Sir Run Run Shaw Hospital, Zhejiang University School of MedHangzhou, 310016, China
Completed
The Third Affiliated Hospital, Sun Yat-Sen UniversityGuangzhou, 510630, China
Completed
The Second Affiliated Hospital of Nanchang UniversityNanchang, 330006, China
Withdrawn
International Peace Maternity&Child Health Hospital of CWIShanghai, 200030, China
Completed
Jiangxi Maternal and Child Health HospitalNanchang, 330006, China
Withdrawn
MultiCare Health Systems Women's Health CareCovington, 98042, United States
Completed
Omni Fertility and Laser InstituteShreveport, 71118, United States
Completed
Helix Biomedics, LLCBoynton Beach, 33435, United States
Completed
Core Healthcare GroupCerritos, 90703, United States
Completed
Synexus Research, LLCRichmond, 23226, United States
Completed
The First Affiliated Hospital of Xinjiang Medical UniversityUrumqi, 830054, China
Withdrawn
Shanghai First Maternity and Infant HospitalShanghai, 200040, China
Completed
Shanghai East Hospital Affiated to Tongji UniversityShanghai, 200123, China
Completed
SUNY Downstate Medical CenterBrooklyn, 11203, United States
Completed
Biopharma Informatic, Inc.Houston, 77043, United States
Withdrawn
Oklahoma UniversityOklahoma City, 73104, United States
Withdrawn
Dedicated Women's Health Specialists, Inc.Puyallup, 98372, United States
Completed
Carolinas Healthcare SystemCharlotte, 28204, United States
Completed
Hospital for Active Treatment - Prof.Paraskev Stoyanov ADLovech, 5500, Bulgaria
Completed
MHAT Dr. Bratan Shukerov ADSmolyan, 4700, Bulgaria
Completed
Multiprofile Hospital for Active Treatment-Dr. T. Venkova ADGabrovo, 5300, Bulgaria
Completed
MHAT for Women's Health - Nadezhda OODSofia, 1330, Bulgaria
Completed
Chattanooga Medical Research, LLCChattanooga, 37404, United States
Withdrawn
Wasatch Clinical Research, LLCSalt Lake City, 84107, United States
Withdrawn
Advocate LutheranPark Ridge, 60068, United States
Withdrawn
University of LouisvilleLouisville, 40202, United States
Completed
Houston Center for Clinical Research, LLCSugarland, 77479, United States
Completed
University of Alabama at BirminghamBirmingham, 35294-0026, United States
Completed
Dr. Victoria Garcia & Associates, LLC Doral Medical ResearchDoral, 33166, United States
Completed
Discovery Clinical ResearchPlantation, 33324, United States
Withdrawn
The Clinical Research InstituteHialeah, 33012, United States
Completed
National Research Institute - Los AngelesLos Angeles, 90057, United States
Completed
Georgia Center For WomenAtlanta, 30312, United States
Completed
The Center for Clinical Trials, Inc.Houston, 77082, United States
Withdrawn
Wake Forest Baptist HealthWinston-Salem, 27103, United States
Withdrawn
Christiana Care Health SystemNewark, 10713, United States
Withdrawn
Serenity Holistic OBGYNNorth Miami Beach, 33162, United States
Completed
South Florida Medical ResearchAventura, 33180, United States
Completed
Millennium Clinical Trials, LLCArlington, 22207, United States
Completed
Main Line Fertility CenterBryn Mawr, 19010, United States
Withdrawn
University of Rochester Medical CenterRochester, 14623, United States
Completed
California Center for Clinical ResearchArcadia, 91007, United States
Withdrawn
Sutter East Bay Medical CenterBerkeley, 94704, United States
Withdrawn
IU Health University HospitalIndianapolis, 46202, United States
Withdrawn
Inova Fairfax Hospital - Falls ChurchFalls Church, 22042, United States
Completed
Dr L Reynders PracticeLyttelton Manor, 0141, South Africa
Completed
Umhlanga Medical CentreDurban, 4319, South Africa
Completed
Wilgeheuwel HospitalRoodepoort, 1724, South Africa
Withdrawn
WITS Clinical Research SiteJohannesburg, 2193, South Africa
Completed
Ethekwini Hospital & Heart CentreDurban, South Africa
Completed
Soukroma gynekologicka ambulanceFulnek, 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 CenterHadera, 3810101, Israel
Completed
The First Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, 710061, China
Completed
Second Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, 710004, China
Completed
1st Affiliated hospital of Soochow UniversitySuzhou, 215006, China
Withdrawn
National University HospitalSingapore, 119074, Singapore
Completed
KK Women's and Children's HospitalSingapore, 229899, Singapore
Completed
P3 ResearchTauranga, 3110, New Zealand
Completed
P3 Research Ltd Hawkes BayHawkes Bay, 4130, New Zealand
Withdrawn
Rambam Health CorporationHaifa, 3109601, Israel
Completed
Family Medicine ClinicGeorgetown, 78626, United States
Completed
Lady Davis Carmel Medical CenterHaifa, 3436212, Israel
Completed
Meir Medical CenterKfar Saba, 4428164, Israel
Completed
Clalit Health Services through HaEmek Medical CenterAfula, 1834111, Israel
Withdrawn
Shanghai General HospitalShanghai, 200080, China
Completed
AVIVA ResearchEscondido, 92025, United States
Completed
Advantia Health, LLC Obstetrics & Gynecology Assoc.Silver Spring, 20910, United States
Completed
Simmonds, Martin and HelmbrechtGaithersburg, 20878, United States
Completed
Paramount Research Solutions-NashvilleNashville, 37203, United States
Withdrawn
Ana Tomayo, MDPembroke Pines, 33024, United States
Completed
Zhongda Hospital Southeast UniversityNanjing, 210009, China
Withdrawn
Nanjing First HospitalNanjing, 210006, China
Completed
University Hospital Kebangsaan MalaysiaKuala Lumpur, 56000, Malaysia
Completed
Hospital Wanita dan Kanak-Kanak SabahSabah, 88996, Malaysia
Completed
Sarawak General HospitalSarawak, 93400, Malaysia
Completed
Ideal Clinical ResearchAventura, 33180, United States
Completed
Fusion Clinical Research of Spartanburg, LLCSpartanburg, 29301, United States
Completed
Boai Hospital of ZhongshanZhongshan, China
Completed
Harbor - UCLA Medical CenterTorrance, 90509-2910, United States
Withdrawn
Clinical Research Consultants of Altanta, LLCSuwanee, 30024, United States
Withdrawn
Brownstone Clinical Trials, LLCFort Worth, 76104, United States
Completed
Ocean Blue Medical Research Center, Inc.Miami Springs, 33166, United States
Completed
Guangzhou Women and Children's Medical CenterGuangzhou, 510623, China
Withdrawn
Asheville Women's Medical CenterAsheville, 28801, United States
Completed
Beijing Friendship Hospital, Capital Medical UniversityBeijing, 100050, China
Completed
Fellows Research Alliance - SavannahSavannah, 31406, United States
Completed
Wake Research, Inc.Raleigh, 27612, United States
Withdrawn
University of Illinois at Chicago | Department of NeurologyChicago, 60612, United States
Completed
Fellows Research Alliance, Inc.Bluffton, 29910, United States
Completed
Willowbend Health & Wellness AssociatesFrisco, 75035, United States
Completed
Altus ResearchLake Worth, 33461, United States
Completed
Paramount Research Solutions-College ParkCollege Park, 30349, United States
Completed
Centex Studies, Inc.Houston, 77058, United States
Withdrawn
Dolphin Medical ResearchDoral, 33172, United States
Withdrawn
The 2nd Hospital of Hebei Medical UniversityShijiazhuang, 050000, China
Withdrawn
Aventura Clinical Research, LLCMiramar, 33027, United States
Withdrawn
The Second Hospital of Jilin UniversityChangchun, 130000, China
Withdrawn
The Second Affiliated Hospital of Nanjing Medical universityNanjing, 210011, China
Withdrawn
The First Affiliated Hospital of Anhui Medical UniversityHefei, 230022, China
Withdrawn
Lanzhou University Second HospitalLanzhou, 730030, China
Withdrawn
The First Affiliated Hospital of Wenzhou Medical Univ (New)Wenzhou, 325000, China
Withdrawn
Beijing Luhe Hospital of Capital Medicial UniversityBeijing, 101199, China
Withdrawn
The People's Hospital of Guangxi Zhuang Autonomous RegionNanning, 530021, China

Primary Outcome

  • Number of participants with amenorrhea
    Amenorrhea 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) response
    HMB 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 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).
    date_rangeTime 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.
    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 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.
    date_rangeTime Frame:
    Up to 2 weeks after end of treatment

Trial design

A randomized, parallel-group, double-blind and open-label placebo-controlled, multicenter study to assess the efficacy and safety of vilaprisan in subjects with uterine fibroids
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
4