Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)
- Registration Number
- NCT03400943
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 93
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vilaprisan (A2) Vilaprisan (BAY1002670) Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break. Placebo+Vilaprisan (B1) Vilaprisan (BAY1002670) Placebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode. Vilaprisan (A1) Placebo Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode. Vilaprisan (A1) Vilaprisan (BAY1002670) Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode. Vilaprisan+Placebo (B2) Placebo Vilaprisan (2 mg) in treatment period 1 for 12 weeks and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode. Vilaprisan+Placebo (B2) Vilaprisan (BAY1002670) Vilaprisan (2 mg) 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 (2 mg) 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 measured by 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 response was defined as MBL \<80 mL during the last 28 days of treatment and \>50% reduction from baseline based on AH-method.
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).
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 based on 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 Uterine Fibroid Daily Bleeding Diary (UF-DBD).
Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) Up to 2 weeks after end of treatment Number of participants with endometrial histology findings, e.g. benign endometrium, Malignant Neoplasm, Hyperplasia WHO 2014, no atypia or Hyperplasia WHO 2014, atypia and Endometrial Polyps.
Change From Baseline of Endometrial Thickness Treatment phase (up to 2 weeks after end of treatment) and follow-up phase (starts on the day after the end of the treatment until the last study visit [up to approximately 2 years]) 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.
Trial Locations
- Locations (103)
South Florida Medical Research
🇺🇸Aventura, Florida, United States
Chattanooga Medical Research, LLC
🇺🇸Chattanooga, Tennessee, United States
Sweet Hope Research Specialty, Inc. - Hialeah
🇺🇸Hialeah, Florida, United States
One Health Research Clinic
🇺🇸Norcross, Georgia, United States
PharmaSite Research, Inc.
🇺🇸Baltimore, Maryland, United States
Houston Center for Clinical Research, LLC
🇺🇸Sugar Land, Texas, United States
Georgia Center For Women
🇺🇸Atlanta, Georgia, United States
Atlanta Women's Research Institute, Inc. - Alpharetta
🇺🇸Atlanta, Georgia, United States
Medisense, Inc.
🇺🇸Atlanta, Georgia, United States
Dr. Victoria Garcia & Associates, LLC Doral Medical Research
🇺🇸Doral, Florida, United States
Centex Studies, Inc.
🇺🇸Houston, Texas, United States
The Center for Clinical Trials, Inc.
🇺🇸Houston, Texas, United States
Beijing Tiantan Hospital, Captial Medical University
🇨🇳Beijing, China
MHAT Dr. Bratan Shukerov AD
🇧🇬Smolyan, Bulgaria
Umhlanga Medical Centre
🇿🇦Durban, Kwazulu-Natal, South Africa
Ideal Clinical Research
🇺🇸Aventura, Florida, United States
National Research Institute - Los Angeles
🇺🇸Los Angeles, California, United States
California Center for Clinical Research
🇺🇸Arcadia, California, United States
Core Healthcare Group
🇺🇸Cerritos, California, United States
AVIVA Research
🇺🇸Escondido, California, United States
Helix Biomedics, LLC
🇺🇸Boynton Beach, Florida, United States
Altus Research
🇺🇸Lake Worth, Florida, United States
Axcess Medical Research, LLC
🇺🇸Loxahatchee Groves, Florida, United States
Ocean Blue Medical Research Center, Inc.
🇺🇸Miami Springs, Florida, United States
Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare
🇺🇸Jacksonville, Florida, United States
ONCOVA Clinical Research, Inc.
🇺🇸Saint Cloud, Florida, United States
Agile Clinical Research Trials, LLC
🇺🇸Atlanta, Georgia, United States
Discovery Clinical Research
🇺🇸Plantation, Florida, United States
Paramount Research Solutions-College Park
🇺🇸College Park, Georgia, United States
GTC Research
🇺🇸Shawnee Mission, Kansas, United States
Simmonds, Martin and Helmbrecht
🇺🇸Gaithersburg, Maryland, United States
Advantia Health, LLC Obstetrics & Gynecology Assoc.
🇺🇸Silver Spring, Maryland, United States
Carolinas Healthcare System
🇺🇸Charlotte, North Carolina, United States
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States
Unified Women's Clinical Research - Morehead City
🇺🇸Morehead City, North Carolina, United States
Fellows Research Alliance, Inc.
🇺🇸Bluffton, South Carolina, United States
Clinical Research of Philadelphia, LLC
🇺🇸Philadelphia, Pennsylvania, United States
Wake Research, Inc.
🇺🇸Raleigh, North Carolina, United States
Fusion Clinical Research of Spartanburg, LLC
🇺🇸Spartanburg, South Carolina, United States
Eastern Carolina Women's Center
🇺🇸New Bern, North Carolina, United States
Main Line Fertility Center
🇺🇸Bryn Mawr, Pennsylvania, United States
Clinical Neurosciences Solutions, Inc DBA CNS Healthcare
🇺🇸Memphis, Tennessee, United States
Paramount Research Solutions-Nashville
🇺🇸Nashville, Tennessee, United States
Willowbend Health & Wellness Associates
🇺🇸Frisco, Texas, United States
Biopharma Informatic, Inc.
🇺🇸Houston, Texas, United States
Family Medicine Clinic
🇺🇸Georgetown, Texas, United States
Multiprofile Hospital for Active Treatment-Dr. T. Venkova AD
🇧🇬Gabrovo, Bulgaria
Millennium Clinical Trials, LLC
🇺🇸Arlington, Virginia, United States
Hospital for Active Treatment - Prof.Paraskev Stoyanov AD
🇧🇬Lovech, Bulgaria
900th Hospital of Joint Logistics Support Force
🇨🇳Fuzhou, Fujian, China
Guangzhou Women and Children's Medical Center
🇨🇳Guangzhou, Guangdong, China
MHAT for Women's Health - Nadezhda OOD
🇧🇬Sofia, Bulgaria
The Third Affiliated Hospital, Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
Boai Hospital of Zhongshan
🇨🇳Zhongshan, Guangdong, China
Nanjing Maternity and Child Health Care Hospital
🇨🇳Nanjing, Jiangsu, China
Wuhan Tongji Reproductive Medicine Hospital
🇨🇳Wuhan, Hubei, China
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
🇨🇳Nanjing, Jiangsu, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, Jiangsu, China
Hainan General Hospital
🇨🇳Haikou, Hainan, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
1st Affiliated hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
Jiangxi Maternal and Child Health Hospital
🇨🇳Nanchang, Jiangxi, China
Lady Davis Carmel Medical Center
🇮🇱Haifa, Israel
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The First Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China
Women's Hospital School of Medicine Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
Sarawak General Hospital
🇲🇾Sarawak, Malaysia
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China
The Second Affiliated Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Sir Run Run Shaw Hospital, Zhejiang University School of Med
🇨🇳Hangzhou, Zhejiang, China
The Second Affliated Hospital of Wenzhou Medicial University
🇨🇳Wenzhou, Zhejiang, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, China
Beijing Hospital of Traditional Chinese Medicine
🇨🇳Beijing, China
Peking University First Hospital
🇨🇳Beijing, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, China
Shanghai East Hospital Affiated to Tongji University
🇨🇳Shanghai, China
Gynekologie MEDA s.r.o.
🇨🇿Brno, Czechia
Gynekologie Studentsky dum s.r.o.
🇨🇿Praha 6, Czechia
Hillel Yaffe Medical Center
🇮🇱Hadera, Israel
Soukroma gynekologicka ambulance
🇨🇿Fulnek, Czechia
MUDr. Ivana Salamonova s.r.o.
🇨🇿Vysoke Myto, Czechia
Hospital Wanita dan Kanak-Kanak Sabah
🇲🇾Sabah, Malaysia
Clalit Health Services through HaEmek Medical Center
🇮🇱Afula, Israel
Meir Medical Center
🇮🇱Kfar Saba, Israel
University Hospital Kebangsaan Malaysia
🇲🇾Kuala Lumpur, Malaysia
KK Women's and Children's Hospital
🇸🇬Singapore, Singapore
P3 Research Ltd Hawkes Bay
🇳🇿Hawkes Bay, New Zealand
P3 Research
🇳🇿Tauranga, New Zealand
Dr L Reynders Practice
🇿🇦Lyttelton Manor, Gauteng, South Africa
Wilgeheuwel Hospital
🇿🇦Roodepoort, Gauteng, South Africa
Ethekwini Hospital & Heart Centre
🇿🇦Durban, Kwazulu-Natal, South Africa
Omni Fertility and Laser Institute
🇺🇸Shreveport, Louisiana, United States
Harbor - UCLA Medical Center
🇺🇸Torrance, California, United States
Fellows Research Alliance - Savannah
🇺🇸Savannah, Georgia, United States
Texas Health Care, PLLC
🇺🇸Fort Worth, Texas, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Accelerated Enrollment Solutions a business of PPD
🇺🇸Orlando, Florida, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Synexus Research, LLC
🇺🇸Richmond, Virginia, United States