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

Uterine Fibroids Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03400943
• Other study ID #: 15787
• Secondary ID: 2017-002997-38
• Status: Terminated
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

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])

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