Trial Condition(s):
Uterine Fibroids
Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine Fibroids (ASTEROID 3)
Bayer Identifier:
15787
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
- 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
Exclusion Criteria
-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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
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Locations Tianjin Medical University General Hospital Tianjin, China, 300052 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Beijing Tiantan Hospital, Captial Medical University Beijing, China, 100050 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clinical Neurosciences Solutions, Inc DBA CNS Healthcare Memphis, United States, 38119 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Eastern Carolina Women's Center New Bern, United States, 28562 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Unified Women's Clinical Research - Morehead City Morehead City, United States, 28557 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clinical Research of Philadelphia, LLC Philadelphia, United States, 19114 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Atlanta Women's Research Institute, Inc. - Alpharetta Atlanta, United States, 30342 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medisense, Inc. Atlanta, United States, 30363 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations GTC Research Shawnee, United States, 66218 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations ONCOVA Clinical Research, Inc. Saint Cloud, United States, 34769 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations PharmaSite Research, Inc. Baltimore, United States, 21208 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare Jacksonville, United States, 32256 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations One Health Research Clinic Norcross, United States, 30093 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Beijing Hospital of Traditional Chinese Medicine Beijing, China, 100010 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The Second Affiliated Hospital of Shanxi Medical University Taiyuan, China, 030001 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations General Hospital of Ningxia Medical University Yinchuan, China, 750004 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Texas Health Care, PLLC Ft. Worth, United States, 76104 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Agile Clinical Research Trials, LLC Atlanta, United States, 30328 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sweet Hope Research Specialty, Inc. - Hialeah Hialeah, United States, 33016 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The Second Affliated Hospital of Wenzhou Medicial University Wenzhou, China, 325000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Shengjing Hospital of China Medical University Shenyang, China, 110022 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations 900th Hospital of Joint Logistics Support Force Fuzhou, China, 350025 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Nanjing Maternity and Child Health Care Hospital Nanjing, China, 210004 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School Nanjing, China, 210008 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Wuhan Tongji Reproductive Medicine Hospital Wuhan, China, 430013 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The First Hospital of Jilin University Changchun, China, 130000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medical University of South Carolina Charleston, United States, 29425 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Axcess Medical Research, LLC Loxahatchee, United States, 33470 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Accelerated Enrollment Solutions a business of PPD Orlando, United States, 32808 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Peking University First Hospital Beijing, China, 100034 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The First Affiliated Hospital of Dalian Medical University Dalian, China, 116011 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hainan General Hospital Haikou, China, 570311 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Women's Hospital School of Medicine Zhejiang University Hangzhou, China, 310006 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sir Run Run Shaw Hospital, Zhejiang University School of Med Hangzhou, China, 310016 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The Third Affiliated Hospital, Sun Yat-Sen University Guangzhou, China, 510630 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The Second Affiliated Hospital of Nanchang University Nanchang, China, 330006 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Jiangxi Maternal and Child Health Hospital Nanchang, China, 330006 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Omni Fertility and Laser Institute Shreveport, United States, 71118 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Helix Biomedics, LLC Boynton Beach, United States, 33435 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Core Healthcare Group Cerritos, United States, 90703 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Synexus Research, LLC Richmond, United States, 23226 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The First Affiliated Hospital of Xinjiang Medical University Urumqi, China, 830054 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Shanghai East Hospital Affiated to Tongji University Shanghai, China, 200123 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations SUNY Downstate Medical Center Brooklyn, United States, 11203 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Biopharma Informatic, Inc. Houston, United States, 77043 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Carolinas Healthcare System Charlotte, United States, 28204 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital for Active Treatment - Prof.Paraskev Stoyanov AD Lovech, Bulgaria, 5500 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations MHAT Dr. Bratan Shukerov AD Smolyan, Bulgaria, 4700 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Multiprofile Hospital for Active Treatment-Dr. T. Venkova AD Gabrovo, Bulgaria, 5300 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations MHAT for Women's Health - Nadezhda OOD Sofia, Bulgaria, 1330 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Chattanooga Medical Research, LLC Chattanooga, United States, 37404 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Houston Center for Clinical Research, LLC Sugarland, United States, 77479 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Alabama at Birmingham Birmingham, United States, 35294-0026 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Dr. Victoria Garcia & Associates, LLC Doral Medical Research Doral, United States, 33166 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Discovery Clinical Research Plantation, United States, 33324 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Research Institute - Los Angeles Los Angeles, United States, 90057 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Georgia Center For Women Atlanta, United States, 30312 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The Center for Clinical Trials, Inc. Houston, United States, 77082 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations South Florida Medical Research Aventura, United States, 33180 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Millennium Clinical Trials, LLC Arlington, United States, 22207 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Main Line Fertility Center Bryn Mawr, United States, 19010 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations California Center for Clinical Research Arcadia, United States, 91007 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Dr L Reynders Practice Lyttelton Manor, South Africa, 0141 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Umhlanga Medical Centre Durban, South Africa, 4319 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Wilgeheuwel Hospital Roodepoort, South Africa, 1724 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ethekwini Hospital & Heart Centre Durban, South Africa | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Soukroma gynekologicka ambulance Fulnek, Czech Republic, 74245 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations MUDr. Ivana Salamonova s.r.o. Vysoke Myto, Czech Republic, 566 01 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Gynekologie Studentsky dum s.r.o. Praha 6, Czech Republic, 160 00 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Gynekologie MEDA s.r.o. Brno, Czech Republic, 602 00 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hillel Yaffe Medical Center Hadera, Israel, 3810101 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The First Affiliated Hospital of Xi'an Jiaotong University Xi'an, China, 710061 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Second Affiliated Hospital of Xi'an Jiaotong University Xi'an, China, 710004 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations 1st Affiliated hospital of Soochow University Suzhou, China, 215006 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations KK Women's and Children's Hospital Singapore, Singapore, 229899 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations P3 Research Tauranga, New Zealand, 3110 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations P3 Research Ltd Hawkes Bay Hawkes Bay, New Zealand, 4130 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Family Medicine Clinic Georgetown, United States, 78626 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Lady Davis Carmel Medical Center Haifa, Israel, 3436212 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Meir Medical Center Kfar Saba, Israel, 4428164 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clalit Health Services through HaEmek Medical Center Afula, Israel, 1834111 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations AVIVA Research Escondido, United States, 92025 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Advantia Health, LLC Obstetrics & Gynecology Assoc. Silver Spring, United States, 20910 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Simmonds, Martin and Helmbrecht Gaithersburg, United States, 20878 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Paramount Research Solutions-Nashville Nashville, United States, 37203 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Zhongda Hospital Southeast University Nanjing, China, 210009 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University Hospital Kebangsaan Malaysia Kuala Lumpur, Malaysia, 56000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Wanita dan Kanak-Kanak Sabah Sabah, Malaysia, 88996 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sarawak General Hospital Sarawak, Malaysia, 93400 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ideal Clinical Research Aventura, United States, 33180 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fusion Clinical Research of Spartanburg, LLC Spartanburg, United States, 29301 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Boai Hospital of Zhongshan Zhongshan, China | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Harbor - UCLA Medical Center Torrance, United States, 90509-2910 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ocean Blue Medical Research Center, Inc. Miami Springs, United States, 33166 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Guangzhou Women and Children's Medical Center Guangzhou, China, 510623 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Beijing Friendship Hospital, Capital Medical University Beijing, China, 100050 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fellows Research Alliance - Savannah Savannah, United States, 31406 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Wake Research, Inc. Raleigh, United States, 27612 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fellows Research Alliance, Inc. Bluffton, United States, 29910 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Willowbend Health & Wellness Associates Frisco, United States, 75035 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Altus Research Lake Worth, United States, 33461 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Paramount Research Solutions-College Park College Park, United States, 30349 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centex Studies, Inc. Houston, United States, 77058 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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
Primary Outcome
- Number of participants with amenorrheaAmenorrhea was defined as menstrual blood loss (MBL) <2 mL during the last 28 days of treatment.Timeframe: 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.Timeframe: 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).Timeframe: 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.Timeframe: 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).Timeframe: 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.Timeframe: 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.Timeframe: Up to 2 weeks after end of treatment
Additional Information
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