Clinical trial NCT03194646: Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
Official title: An Open-label, Parallel-group, Randomized, Multicenter Study to Assess the Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Versus Standard of Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Uterine Fibroids
Keywords: Uterine Fibroid
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-06-21
Enrollment: 1272
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Diagnosis of uterine fibroid(s) documented by ultrasound at screening AND/OR during a uterine preserving procedure within 3 months prior to screening in subjects with high risk for recurrence
* At least one symptom of uterine fibroid(s) - bleeding, pelvic pressure/pain
* Good general health
* Normal or clinically insignificant cervical smear
* An endometrial biopsy performed during the screening period, without significant histological disorder
* Use of an acceptable nonhormonal method of contraception starting at Visit 1 until the end of the study

Exclusion Criteria:

* Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
* Hypersensitivity to any ingredient of the study drug
* Any condition requiring immediate blood transfusion
* 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

Primary outcomes:
measure: Percentage Change in Bone Mineral Density (BMD) of Lumbar Spine
timeFrame: From baseline to about 1 year after start of treatment
Secondary outcomes:
measure: Number of Bleeding Days
timeFrame: Treatment phase: approximately 1 year
measure: Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
timeFrame: Up to 3 years (from study treatment start to end of study)
measure: Change From Baseline in Endometrial Thickness
timeFrame: Treatment phase: approximately 1 year, follow-up phase: up to 2 years
measure: Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck
timeFrame: Treatment phase: approximately 1 year, follow-up phase: up to 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Research Associates | Birmingham, AL
state: Alabama
city: Mobile
country: United States
facility: Women's Health Alliance of Mobile
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc
state: Alabama
city: Tucson
country: United States
facility: Visions Clinical Research - Tucson
state: Arizona
city: Little Rock
country: United States
facility: Lynn Health Science Institute | Lynn Institute of the Ozarks
state: Arkansas
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Encinitas
country: United States
facility: Diagnamics | Encinitas, CA
state: California
city: La Mesa
country: United States
facility: Grossmont Center for Clinical Research
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: San Diego
country: United States
facility: Women's Health Care Research | San Diego, CA
state: California
city: San Diego
country: United States
facility: West Coast OB/GYN Associates
state: California
city: Lakewood
country: United States
facility: Physicians' Research Options, LLC | Red Rocks OBGYN
state: Colorado
city: Parker
country: United States
facility: Advanced Women's Health Institute | Denver Office, Greenwood Village, CO
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Stamford
country: United States
facility: Stamford Hospital
state: Connecticut
city: Washington
country: United States
facility: IntimMedicine | Washington, DC
state: District of Columbia
city: Boynton Beach
country: United States
facility: Helix Biomedics LLC | Boynton Beach, FL
state: Florida
city: Clearwater
country: United States
facility: Women's Medical Research Group, LLC
state: Florida
city: Doral
country: United States
facility: Dr. Victoria Garcia & Associates, LLC Doral Medical Research
state: Florida
city: Fort Lauderdale
country: United States
facility: M & O Clinical Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: Solutions Through Advanced Research, Inc.
state: Florida
city: Loxahatchee Groves
country: United States
facility: Axcess Medical Research, LLC
state: Florida
city: Palm Harbor
country: United States
facility: Suncoast Clinical Research Inc | Pinellas
state: Florida
city: Saint Cloud
country: United States
facility: ONCOVA Clinical Research, Inc.
state: Florida
city: Sarasota
country: United States
facility: Swor Women's Care
state: Florida
city: Trinity
country: United States
facility: Suncoast Clinical Research Inc. | Pasco
state: Florida
city: Atlanta
country: United States
facility: Agile Clinical Research Trials, LLC
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Women's Research Institute, Inc. - Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Medisense Inc at Atlantic Station
state: Georgia
city: Augusta
country: United States
facility: Augusta University Medical Center
state: Georgia
city: College Park
country: United States
facility: Paramount Research Solutions | College Park Location
state: Georgia
city: Savannah
country: United States
facility: Fellows Research Alliance, Inc | Savannah, GA
state: Georgia
city: Snellville
country: United States
facility: Journey Medical Research
state: Georgia
city: Palos Heights
country: United States
facility: Center For Women's Research
state: Illinois
city: Wichita
country: United States
facility: Professional Research Network of Kansas, LLC
state: Kansas
city: Owensboro
country: United States
facility: Research Integrity, LLC
state: Kentucky
city: Lake Charles
country: United States
facility: Centex Studies, Inc.
state: Louisiana
city: Marrero
country: United States
facility: Praetorian Pharmaceutical Research, LLC
state: Louisiana
city: Metairie
country: United States
facility: Southern Clinical Research Associates | Metairie, LA
state: Louisiana
city: Shreveport
country: United States
facility: Omni Fertility and Laser Institute
state: Louisiana
city: Columbia
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Pikesville
country: United States
facility: Baltimore Suburban Health, LLC
state: Maryland
city: Towson
country: United States
facility: Continental Clinical Solutions | Towson, MD
state: Maryland
city: Detroit
country: United States
facility: Wayne State University Physicians Group
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Lincoln
country: United States
facility: Women's Clinic of Lincoln, P.C. | Lincoln, NE
state: Nebraska
city: Las Vegas
country: United States
facility: M3 Wake Research | Clinical Research Center of Nevada
state: Nevada
city: Lawrenceville
country: United States
facility: Capital Health | Capital Health OBGYN Lawrenceville
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: Bosque Women's Care | Albuquerque, NM
state: New Mexico
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: New York
country: United States
facility: Manhattan Medical Research
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Staten Island
country: United States
facility: Richmond ObGyn Associates PC
state: New York
city: Charlotte
country: United States
facility: Carolinas Healthcare System
state: North Carolina
city: Durham
country: United States
facility: Carolina Women's Research & Wellness Center
state: North Carolina
city: Greensboro
country: United States
facility: Unified Women's Clinical Research
state: North Carolina
city: Morehead City
country: United States
facility: Unified Women's Clinical Research - Morehead City
state: North Carolina
city: New Bern
country: United States
facility: Eastern Carolina Women's Center | New Bern, NC
state: North Carolina
city: Raleigh
country: United States
facility: Women's Health Alliance
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research | Raleigh, NC
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurst Clinical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Valaoras & Lewis OB/GYN
state: North Carolina
city: Beavercreek
country: United States
facility: Clinical Inquest Center, Ltd.
state: Ohio
city: Dayton
country: United States
facility: Miami Valley Hospital
state: Ohio
city: Englewood
country: United States
facility: HWC Women's Research Center | Englewood, OH
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Clinical Research Philadelphia | Philadelphia, PA
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina | MUSC Center for Womens Health - Department of Obstetrics and Gynecology
state: South Carolina
city: Columbia
country: United States
facility: Vista Clinical Research
state: South Carolina
city: Greenville
country: United States
facility: VitaLink Research - Greenville
state: South Carolina
city: Myrtle Beach
country: United States
facility: Venus Gynecology, LLC | Myrtle Beach, SC
state: South Carolina
city: West Columbia
country: United States
facility: Invocare Clinical Research Center, LLC
state: South Carolina
city: Hixson
country: United States
facility: ClinSearch, LLC
state: Tennessee
city: Memphis
country: United States
facility: Women's Physician Group
state: Tennessee
city: Dallas
country: United States
facility: Discovery Clinical Trials - Dallas
state: Texas
city: Fort Worth
country: United States
facility: Sig Gyn Services (Dr. John A. Whitfield, MD) | Fort Worth, TX
state: Texas
city: Fort Worth
country: United States
facility: Office of Dr. Delbert Alan Johns, MD
state: Texas
city: Georgetown
country: United States
facility: Family Medicine Clinic
state: Texas
city: Houston
country: United States
facility: Advances in Health, INC. | Houston, TX
state: Texas
city: Houston
country: United States
facility: The Woman's Hospital of Texas
state: Texas
city: Irving
country: United States
facility: MacArthur OB/GYN Mangement, LLC
state: Texas
city: Plano
country: United States
facility: Willowbend Health and Wellness Associates
state: Texas
city: San Antonio
country: United States
facility: Seven Oaks Women's Center
state: Texas
city: Franklin
country: United States
facility: OB-GYN Physicians, Inc.
state: Virginia
city: Norfolk
country: United States
facility: Tidewater Clinical Research | Virginia Beach, VA
state: Virginia
city: North Chesterfield
country: United States
facility: Virginia Physicians For Women
state: Virginia
city: Richmond
country: United States
facility: Clinical Trials of Viriginia
state: Virginia
city: Richmond
country: United States
facility: Synexus Research, LLC
state: Virginia
city: Covington
country: United States
facility: MultiCare Health Systems Women's Health Care
state: Washington
city: Fuzhou
country: China
facility: 900th Hospital of Joint Logistics Support Force
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ.
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of TCM
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Shijiazhuang
country: China
facility: The 2nd Hospital of Hebei Medical University
state: Hebei
city: Wuhan
country: China
facility: Wuhan Tongji Reproductive Medicine Hospital
state: Hubei
city: Nanjing
country: China
facility: Nanjing Maternity and Child Health Care Hospital
state: Jiangsu
city: Nanjing
country: China
facility: NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Maternal and Child Health Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun City
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Taiyuan
country: China
facility: The Second Affiliated Hospital of Shanxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: West China Second University Hospital
state: Sichuan
city: Urumchi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Hangzhou
country: China
facility: Women's Hospital School of Medicine Zhejiang University
state: Zhejiang
city: Wenzhou
country: China
facility: The Second Affliated Hospital of Wenzhou Medicial University
state: Zhejiang
city: Beijing
country: China
facility: Beijing Hospital of Traditional Chinese Medicine
city: Beijing
country: China
facility: Beijing Obstetrics and Gynecology Hospital,Capital Med.Uni.
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Captial Medical University
city: Beijing
country: China
facility: Peking Union Medical College Hospital CAMS
city: Shanghai
country: China
facility: International Peace Maternity&Child Health Hospital of CWI
city: Shanghai
country: China
facility: Changhai Hospital of Second Military Medical University
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Tianjin
country: China
facility: First Teaching Hosptial of Tianjin University of TCM
city: Tianjin
country: China
facility: Tianjin Central Hospital of Gynecology obstetrics
city: Písek
country: Czechia
facility: Centrum gynekologicke rehabilitace
state: Jihoceský Kraj
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Ceske Budejovice
country: Czechia
facility: G-Centrum Olomouc s.r.o. Dr. Skrivanek
city: Hradec Kralove
country: Czechia
facility: Fakultni Nemocnice Hradec Kralove
city: Jihlava
country: Czechia
facility: MUDr. Radek Fiker s.r.o.
city: Olomouc
country: Czechia
facility: Fakultni Nemocnice Olomouc
city: Tabor
country: Czechia
facility: Dr. Smrhova-Kovacs
city: Vodnany
country: Czechia
facility: MUDr. Pavlina Nejedla s.r.o.
city: Kuopio
country: Finland
facility: Mehilainen | Mehilainen Kuopio
city: Oulu
country: Finland
facility: Lääkärikeskus Gyneko, Gynaecological Medical Center | Oulu, Finland
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Nagoya
country: Japan
facility: Kano's Clinic for Women
state: Aichi
city: Funabashi
country: Japan
facility: Kyoritsu Narashinodai Hospital
state: Chiba
city: Matsudo
country: Japan
facility: Juno Vesta Clinic Hatta
state: Chiba
city: Iizuka
country: Japan
facility: Aso Iizuka Hospital
state: Fukuoka
city: Koriyama
country: Japan
facility: Jusendo Geneal Hospital Yuasa Foundation
state: Fukushima
city: Takasaki
country: Japan
facility: Sato Hospital
state: Gunma
city: Ebetsu
country: Japan
facility: Primo Women's Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Maternity Women's Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Shiroishi Obstetrics and Gynecology Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Hashimoto Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Ena Odori Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Maternity Women's Minami1jo Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: SAPPORO MEDICAL CENTER, NTT East Corporation
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo West Ladies Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Yoshio Clinic
state: Hokkaido
city: Kanazawa
country: Japan
facility: Ishikawa Prefectural Central Hospital
state: Ishikawa
city: Takamatsu
country: Japan
facility: Asahi-Clinic
state: Kagawa
city: Takamatsu
country: Japan
facility: Kagawa Prefectural Central Hospital
state: Kagawa
city: Kawasaki
country: Japan
facility: Second Kawasaki Saiwai Clinic
state: Kanagawa
city: Kurashiki
country: Japan
facility: Kurashiki Medical Clinic
state: Okayama
city: Suita
country: Japan
facility: Suita Municipal Hospital
state: Osaka
city: Soka
country: Japan
facility: Medical Topia Soka Hospital
state: Saitama
city: Numazu
country: Japan
facility: Fuyo Association Seirei Numazu Hospital
state: Shizuoka
city: Bunkyo
country: Japan
facility: Sei Womens Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Ginza Yoshida Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Women's wellness Tsushima Ruriko josei life clinic Ginza
state: Tokyo
city: Chuoku
country: Japan
facility: St.Luke's International Hospital
state: Tokyo
city: Fuchu
country: Japan
facility: Akazawa Clinic
state: Tokyo
city: Hachioji
country: Japan
facility: Medical Corp. Seikoukai New Medical Research System Clinic
state: Tokyo
city: Minato-ku
country: Japan
facility: Yokokura Clinic
state: Tokyo
city: Minato
country: Japan
facility: Toranomon Womens Clinic
state: Tokyo
city: Minato
country: Japan
facility: Akasakamitsuke Miyazaki Obstetrics and Gynecology Clinic
state: Tokyo
city: Minato
country: Japan
facility: Shirokane Ladies' Clinic
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Kugayama Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo
city: Toshima-ku
country: Japan
facility: Ikebukuro Metropolitan Clinic
state: Tokyo
city: Fukui
country: Japan
facility: Kato Internal medicine and Gynecology Clinic
city: Fukuoka
country: Japan
facility: Sano Wemen's Clinic
city: Kagoshima
country: Japan
facility: Unoki Clinic
city: Osaka
country: Japan
facility: Medical corporation keizukai Chayamachi Ladies Clinic
city: Osaka
country: Japan
facility: Chayamachi ladies Clinic Hommachi
city: Osaka
country: Japan
facility: Medical Corporation Koshinkai Nomura Clinic Namba
city: Osaka
country: Japan
facility: Izuma Clinic
city: Shizuoka
country: Japan
facility: Shizuoka Saiseikai General Hospital
city: Shizuoka
country: Japan
facility: Shizuoka City Shimizu Hospital
city: Monterrey
country: Mexico
facility: Hospital Universitario "José Eleuterio González"
state: Nuevo Leon
city: San Juan del Río
country: Mexico
facility: Centro Integral Médico de San Juan del Río S. C.
state: Querétaro
city: Querétaro
country: Mexico
facility: Sanatorio Alcocer Pozo S. A. de C. V.
city: Fredrikstad
country: Norway
facility: Kirkeparken Spesialistpraksis
city: Nesttun
country: Norway
facility: Nesttun Spesialistpraksis AS
city: Trondheim
country: Norway
facility: Medicus AS
city: Bialystok
country: Poland
facility: Prywatna Klinika Ginekologiczno-Poloznicza
city: Katowice
country: Poland
facility: CLINICAL MEDICAL RESEARCH Sp. z o. o.
city: Katowice
country: Poland
facility: Vita Longa Sp. z o.o.
city: Katowice
country: Poland
facility: Gyncentrum Sp. z o.o.
city: Lodz
country: Poland
facility: Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.
city: Lublin
country: Poland
facility: Centrum Medyczne Chodzki
city: Lublin
country: Poland
facility: Specjalistyczny Gabinet Ginekologiczno-Polozniczy
city: Irkutsk
country: Russian Federation
facility: Scientific Center of family health & human reprod. problems
city: Krasnodar
country: Russian Federation
facility: Regional Clinical Hospital #2
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk regional perinatal center
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #13 Moscow
city: Moscow
country: Russian Federation
facility: Endocrinology Research Center
city: Samara
country: Russian Federation
facility: Close Joint Stock Company "Medical Company IDK"
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg Medical University n.a. I.P. Pavlov
city: St. Petersburg
country: Russian Federation
facility: "Granti-Med"
city: St. Petersburg
country: Russian Federation
facility: Scien. Res. Institute of Obsterics, Gyn. & Reproduction
city: Lyttelton Manor
country: South Africa
facility: Dr L Reynders Practice
state: Gauteng
city: Pretoria
country: South Africa
facility: University of Pretoria, Clinical Research Unit
state: Gauteng
city: Umhlanga
country: South Africa
facility: Femway Inc
state: Kwazulu-Natal
city: Wentworth
country: South Africa
facility: Durban International Clinical Research Site
state: Kwazulu-Natal
city: Cape Town
country: South Africa
facility: Drs AEVITAS Clinic (Pty) Ltd
state: Western Cape
city: Cape Town
country: South Africa
facility: University of Cape Town Clinical Research Centre
state: Western Cape
city: Panorama
country: South Africa
facility: Clintrials Centre for Clinical Research
state: Western Cape
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital, Mahidol
city: Adana
country: Turkey
facility: Cukurova Universitesi Tip Fakultesi Hastanesi
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi Hastanesi
city: Ankara
country: Turkey
facility: Etlik Zubeyde Hanim Kadin Hastaliklari Egitim Arastirma Hast
city: Bursa
country: Turkey
facility: Uludag Universitesi Tip Fakultesi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Istanbul Tip Fakultesi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: