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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03400943
Other study ID # 15787
Secondary ID 2017-002997-38
Status Terminated
Phase Phase 3
First received
Last updated
Start date January 17, 2018
Est. completion date April 6, 2022

Study information

Verified date April 2023
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 93
Est. completion date April 6, 2022
Est. primary completion date June 9, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Vilaprisan (BAY1002670)
2 mg of Vilaprisan once daily up to 2 x 12 weeks
Placebo
Matching placebo was administered to group B1 and B2.

Locations

Country Name City State
Bulgaria Multiprofile Hospital for Active Treatment-Dr. T. Venkova AD Gabrovo
Bulgaria Hospital for Active Treatment - Prof.Paraskev Stoyanov AD Lovech
Bulgaria MHAT Dr. Bratan Shukerov AD Smolyan
Bulgaria MHAT for Women's Health - Nadezhda OOD Sofia
China Beijing Friendship Hospital, Capital Medical University Beijing
China Beijing Hospital of Traditional Chinese Medicine Beijing
China Beijing Tiantan Hospital, Captial Medical University Beijing
China Peking University First Hospital Beijing
China The First Hospital of Jilin University Changchun Jilin
China The First Affiliated Hospital of Dalian Medical University Dalian Liaoning
China 900th Hospital of Joint Logistics Support Force Fuzhou Fujian
China Guangzhou Women and Children's Medical Center Guangzhou Guangdong
China The Third Affiliated Hospital, Sun Yat-Sen University Guangzhou Guangdong
China Hainan General Hospital Haikou Hainan
China Sir Run Run Shaw Hospital, Zhejiang University School of Med Hangzhou Zhejiang
China Women's Hospital School of Medicine Zhejiang University Hangzhou Zhejiang
China Jiangxi Maternal and Child Health Hospital Nanchang Jiangxi
China The Second Affiliated Hospital of Nanchang University Nanchang Jiangxi
China Nanjing Maternity and Child Health Care Hospital Nanjing Jiangsu
China NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School Nanjing Jiangsu
China Zhongda Hospital Southeast University Nanjing Jiangsu
China Shanghai East Hospital Affiated to Tongji University Shanghai
China Shengjing Hospital of China Medical University Shenyang Liaoning
China 1st Affiliated hospital of Soochow University Suzhou Jiangsu
China The Second Affiliated Hospital of Shanxi Medical University Taiyuan Shanxi
China Tianjin Medical University General Hospital Tianjin
China The First Affiliated Hospital of Xinjiang Medical University Urumqi Xinjiang
China The Second Affliated Hospital of Wenzhou Medicial University Wenzhou Zhejiang
China Wuhan Tongji Reproductive Medicine Hospital Wuhan Hubei
China Second Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi
China The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi
China General Hospital of Ningxia Medical University Yinchuan Ningxia
China Boai Hospital of Zhongshan Zhongshan Guangdong
Czechia Gynekologie MEDA s.r.o. Brno
Czechia Soukroma gynekologicka ambulance Fulnek
Czechia Gynekologie Studentsky dum s.r.o. Praha 6
Czechia MUDr. Ivana Salamonova s.r.o. Vysoke Myto
Israel Clalit Health Services through HaEmek Medical Center Afula
Israel Hillel Yaffe Medical Center Hadera
Israel Lady Davis Carmel Medical Center Haifa
Israel Meir Medical Center Kfar Saba
Malaysia University Hospital Kebangsaan Malaysia Kuala Lumpur
Malaysia Hospital Wanita dan Kanak-Kanak Sabah Sabah
Malaysia Sarawak General Hospital Sarawak
New Zealand P3 Research Ltd Hawkes Bay Hawkes Bay
New Zealand P3 Research Tauranga
Singapore KK Women's and Children's Hospital Singapore
South Africa Ethekwini Hospital & Heart Centre Durban Kwazulu-Natal
South Africa Umhlanga Medical Centre Durban Kwazulu-Natal
South Africa Dr L Reynders Practice Lyttelton Manor Gauteng
South Africa Wilgeheuwel Hospital Roodepoort Gauteng
United States California Center for Clinical Research Arcadia California
United States Millennium Clinical Trials, LLC Arlington Virginia
United States Agile Clinical Research Trials, LLC Atlanta Georgia
United States Atlanta Women's Research Institute, Inc. - Alpharetta Atlanta Georgia
United States Georgia Center For Women Atlanta Georgia
United States Medisense, Inc. Atlanta Georgia
United States Ideal Clinical Research Aventura Florida
United States South Florida Medical Research Aventura Florida
United States PharmaSite Research, Inc. Baltimore Maryland
United States University of Alabama at Birmingham Birmingham Alabama
United States Fellows Research Alliance, Inc. Bluffton South Carolina
United States Helix Biomedics, LLC Boynton Beach Florida
United States SUNY Downstate Medical Center Brooklyn New York
United States Main Line Fertility Center Bryn Mawr Pennsylvania
United States Core Healthcare Group Cerritos California
United States Medical University of South Carolina Charleston South Carolina
United States Carolinas Healthcare System Charlotte North Carolina
United States Chattanooga Medical Research, LLC Chattanooga Tennessee
United States Paramount Research Solutions-College Park College Park Georgia
United States Dr. Victoria Garcia & Associates, LLC Doral Medical Research Doral Florida
United States AVIVA Research Escondido California
United States Texas Health Care, PLLC Fort Worth Texas
United States Willowbend Health & Wellness Associates Frisco Texas
United States Simmonds, Martin and Helmbrecht Gaithersburg Maryland
United States Family Medicine Clinic Georgetown Texas
United States Sweet Hope Research Specialty, Inc. - Hialeah Hialeah Florida
United States Biopharma Informatic, Inc. Houston Texas
United States Centex Studies, Inc. Houston Texas
United States The Center for Clinical Trials, Inc. Houston Texas
United States Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare Jacksonville Florida
United States Altus Research Lake Worth Florida
United States National Research Institute - Los Angeles Los Angeles California
United States Axcess Medical Research, LLC Loxahatchee Groves Florida
United States Clinical Neurosciences Solutions, Inc DBA CNS Healthcare Memphis Tennessee
United States Ocean Blue Medical Research Center, Inc. Miami Springs Florida
United States Unified Women's Clinical Research - Morehead City Morehead City North Carolina
United States Paramount Research Solutions-Nashville Nashville Tennessee
United States Eastern Carolina Women's Center New Bern North Carolina
United States One Health Research Clinic Norcross Georgia
United States Accelerated Enrollment Solutions a business of PPD Orlando Florida
United States Clinical Research of Philadelphia, LLC Philadelphia Pennsylvania
United States Discovery Clinical Research Plantation Florida
United States Wake Research, Inc. Raleigh North Carolina
United States Synexus Research, LLC Richmond Virginia
United States ONCOVA Clinical Research, Inc. Saint Cloud Florida
United States Fellows Research Alliance - Savannah Savannah Georgia
United States GTC Research Shawnee Mission Kansas
United States Omni Fertility and Laser Institute Shreveport Louisiana
United States Advantia Health, LLC Obstetrics & Gynecology Assoc. Silver Spring Maryland
United States Fusion Clinical Research of Spartanburg, LLC Spartanburg South Carolina
United States Houston Center for Clinical Research, LLC Sugar Land Texas
United States Harbor - UCLA Medical Center Torrance California

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Bulgaria,  China,  Czechia,  Israel,  Malaysia,  New Zealand,  Singapore,  South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Amenorrhea Amenorrhea was defined as menstrual blood loss (MBL) <2 mL during the last 28 days of treatment measured by the alkaline hematin (AH) method. The last 28 days of treatment period 1
Secondary 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 based on AH-method. The last 28 days of treatment period 1 and treatment period 2
Secondary 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). In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)
Secondary 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 based on AH-method. In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)
Secondary 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). The last 28 days of treatment period 1 and treatment period 2
Secondary 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 WHO 2014, atypia and Endometrial Polyps. Up to 2 weeks after end of treatment
Secondary 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. 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])
See also
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Terminated NCT05026502 - A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules
Withdrawn NCT04567095 - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Patients in Canada
Withdrawn NCT03699176 - Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Phase 3
Not yet recruiting NCT02884960 - Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization N/A
Completed NCT02472184 - Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy N/A
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Completed NCT01452659 - Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids Phase 2
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