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Spots Global Cancer Trial Database for Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)

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Trial Identification

Brief Title: Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)

Official Title: 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

Study ID: NCT03400943

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

University of Alabama at Birmingham, Birmingham, Alabama, United States

California Center for Clinical Research, Arcadia, California, United States

Core Healthcare Group, Cerritos, California, United States

AVIVA Research, Escondido, California, United States

National Research Institute - Los Angeles, Los Angeles, California, United States

Harbor - UCLA Medical Center, Torrance, California, United States

Ideal Clinical Research, Aventura, Florida, United States

South Florida Medical Research, Aventura, Florida, United States

Helix Biomedics, LLC, Boynton Beach, Florida, United States

Dr. Victoria Garcia & Associates, LLC Doral Medical Research, Doral, Florida, United States

Sweet Hope Research Specialty, Inc. - Hialeah, Hialeah, Florida, United States

Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare, Jacksonville, 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

Accelerated Enrollment Solutions a business of PPD, Orlando, Florida, United States

Discovery Clinical Research, Plantation, Florida, United States

ONCOVA Clinical Research, Inc., Saint Cloud, Florida, United States

Georgia Center For Women, Atlanta, Georgia, United States

Agile Clinical Research Trials, LLC, Atlanta, Georgia, United States

Atlanta Women's Research Institute, Inc. - Alpharetta, Atlanta, Georgia, United States

Medisense, Inc., Atlanta, Georgia, United States

Paramount Research Solutions-College Park, College Park, Georgia, United States

One Health Research Clinic, Norcross, Georgia, 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

PharmaSite Research, Inc., Baltimore, Maryland, United States

Simmonds, Martin and Helmbrecht, Gaithersburg, Maryland, United States

Advantia Health, LLC Obstetrics & Gynecology Assoc., Silver Spring, Maryland, United States

SUNY Downstate Medical Center, Brooklyn, New York, United States

Carolinas Healthcare System, Charlotte, North Carolina, United States

Unified Women's Clinical Research - Morehead City, Morehead City, North Carolina, United States

Eastern Carolina Women's Center, New Bern, North Carolina, United States

Wake Research, Inc., Raleigh, North Carolina, United States

Main Line Fertility Center, Bryn Mawr, Pennsylvania, United States

Clinical Research of Philadelphia, LLC, Philadelphia, Pennsylvania, United States

Fellows Research Alliance, Inc., Bluffton, South Carolina, United States

Medical University of South Carolina, Charleston, South Carolina, United States

Fusion Clinical Research of Spartanburg, LLC, Spartanburg, South Carolina, United States

Chattanooga Medical Research, LLC, Chattanooga, Tennessee, United States

Clinical Neurosciences Solutions, Inc DBA CNS Healthcare, Memphis, Tennessee, United States

Paramount Research Solutions-Nashville, Nashville, Tennessee, United States

Texas Health Care, PLLC, Fort Worth, Texas, United States

Willowbend Health & Wellness Associates, Frisco, Texas, United States

Family Medicine Clinic, Georgetown, Texas, 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

Houston Center for Clinical Research, LLC, Sugar Land, Texas, United States

Millennium Clinical Trials, LLC, Arlington, Virginia, United States

Synexus Research, LLC, Richmond, Virginia, United States

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, , Bulgaria

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

Boai Hospital of Zhongshan, Zhongshan, Guangdong, China

Hainan General Hospital, Haikou, Hainan, China

Wuhan Tongji Reproductive Medicine Hospital, Wuhan, Hubei, 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

1st Affiliated hospital of Soochow University, Suzhou, Jiangsu, China

Jiangxi Maternal and Child Health Hospital, Nanchang, Jiangxi, China

The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China

The First Hospital of Jilin University, Changchun, Jilin, 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

The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China

The Second Affiliated Hospital of Shanxi Medical University, Taiyuan, Shanxi, China

The First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China

Women's Hospital School of Medicine Zhejiang University, Hangzhou, Zhejiang, 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 Hospital of Traditional Chinese Medicine, Beijing, , China

Peking University First Hospital, Beijing, , China

Beijing Friendship Hospital, Capital Medical University, Beijing, , China

Beijing Tiantan Hospital, Captial Medical University, Beijing, , China

Shanghai East Hospital Affiated to Tongji University, Shanghai, , China

Tianjin Medical University General Hospital, Tianjin, , China

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, , Czechia

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, , Israel

University Hospital Kebangsaan Malaysia, Kuala Lumpur, , Malaysia

Hospital Wanita dan Kanak-Kanak Sabah, Sabah, , Malaysia

Sarawak General Hospital, Sarawak, , Malaysia

P3 Research Ltd Hawkes Bay, Hawkes Bay, , New Zealand

P3 Research, Tauranga, , New Zealand

KK Women's and Children's Hospital, Singapore, , Singapore

Dr L Reynders Practice, Lyttelton Manor, Gauteng, South Africa

Wilgeheuwel Hospital, Roodepoort, Gauteng, South Africa

Umhlanga Medical Centre, Durban, Kwazulu-Natal, South Africa

Ethekwini Hospital & Heart Centre, Durban, Kwazulu-Natal, South Africa

Contact Details

Name: Bayer Study Director

Affiliation: Bayer

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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