Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

Uterine Fibroids Clinical Trial

— ASTEROID 6  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03194646
• Other study ID #: 16953
• Secondary ID: 2016-004822-41
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 30, 2017
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1272
• Est. completion date: June 30, 2024
• Est. primary completion date: May 10, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

Drug:
• Vilaprisan (BAY1002670)
2 mg of Vilaprisan once daily for 12 weeks, 4 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen).
• Vilaprisan (BAY1002670)
2 mg of Vilaprisan once daily for 24 weeks, 2 treatment periods of 24 weeks, each separated by 2 bleeding episodes (6/2 regimen).
• Vilaprisan (BAY1002670)
2 mg of Vilaprisan once daily for 12 weeks, 4 treatment periods of 12 weeks, each separated by 2 bleeding episodes (3/2 regimen).

Other:
• Standard of care
Standard of care as determined by the investigators (including watch and wait, symptomatic nonhormonal)

Drug:
• Vilaprisan (BAY1002670)
2 mg of Vilaprisan once daily for 12 weeks, 8 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen)
• Vilaprisan (BAY1002670)
2 mg of Vilaprisan once daily for 24 weeks, 4 treatment periods of 24 weeks, each separated by 2 bleeding episodes (6/2 regimen)
• Vilaprisan (BAY1002670)
2 mg of Vilaprisan once daily for 12 weeks, 6 treatment periods of 12 weeks, each separated by 2 bleeding episodes (3/2 regimen)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  China,  Czechia,  Finland,  Hong Kong,  Japan,  Mexico,  Norway,  Poland,  Russian Federation,  South Africa,  Thailand,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Change in Bone Mineral Density (BMD) of Lumbar Spine	The percentage change in BMD (measured by dual-energy X-ray absorptiometry (DEXA) scan) of lumbar spine from baseline to about one year after start of treatment (SoT) in all randomized and treated participants with measurements at those 2 time points in each treatment group.	From baseline to about 1 year after start of treatment
Secondary	Number of Bleeding Days	Number of bleeding days were defined from Day 1 of the first treatment period until the day before a new treatment period would start again following the last treatment period for that respective treatment group. Number to be normalized by 28 days	Treatment phase: approximately 1 year
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, presence or absence of hyperplasia or malignancy	Up to 3 years (from study treatment start to end of study)
Secondary	Change From Baseline in 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 (worst measurement during baseline period) in endometrial thickness was provided in below table.	Treatment phase: approximately 1 year, follow-up phase: up to 2 years
Secondary	Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck	Percentage change in BMD (measured by dual-energy X-ray absorptiometry (DEXA) scan) of lumbar spine (other time points not mentioned as primary safety analysis), hip, and femoral neck from baseline was analyzed using the same statistical methods as used for the primary variable.	Treatment phase: approximately 1 year, follow-up phase: up to 2 years

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