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

Primary Purpose

Uterine Fibroids

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vilaprisan (BAY1002670)
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroids focused on measuring Heavy menstrual bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • California Center for Clinical Research
  • Core Healthcare Group
  • AVIVA Research
  • National Research Institute - Los Angeles
  • Harbor - UCLA Medical Center
  • Ideal Clinical Research
  • South Florida Medical Research
  • Helix Biomedics, LLC
  • Dr. Victoria Garcia & Associates, LLC Doral Medical Research
  • Sweet Hope Research Specialty, Inc. - Hialeah
  • Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare
  • Altus Research
  • Axcess Medical Research, LLC
  • Ocean Blue Medical Research Center, Inc.
  • Accelerated Enrollment Solutions a business of PPD
  • Discovery Clinical Research
  • ONCOVA Clinical Research, Inc.
  • Georgia Center For Women
  • Agile Clinical Research Trials, LLC
  • Atlanta Women's Research Institute, Inc. - Alpharetta
  • Medisense, Inc.
  • Paramount Research Solutions-College Park
  • One Health Research Clinic
  • Fellows Research Alliance - Savannah
  • GTC Research
  • Omni Fertility and Laser Institute
  • PharmaSite Research, Inc.
  • Simmonds, Martin and Helmbrecht
  • Advantia Health, LLC Obstetrics & Gynecology Assoc.
  • SUNY Downstate Medical Center
  • Carolinas Healthcare System
  • Unified Women's Clinical Research - Morehead City
  • Eastern Carolina Women's Center
  • Wake Research, Inc.
  • Main Line Fertility Center
  • Clinical Research of Philadelphia, LLC
  • Fellows Research Alliance, Inc.
  • Medical University of South Carolina
  • Fusion Clinical Research of Spartanburg, LLC
  • Chattanooga Medical Research, LLC
  • Clinical Neurosciences Solutions, Inc DBA CNS Healthcare
  • Paramount Research Solutions-Nashville
  • Texas Health Care, PLLC
  • Willowbend Health & Wellness Associates
  • Family Medicine Clinic
  • Biopharma Informatic, Inc.
  • Centex Studies, Inc.
  • The Center for Clinical Trials, Inc.
  • Houston Center for Clinical Research, LLC
  • Millennium Clinical Trials, LLC
  • Synexus Research, LLC
  • Multiprofile Hospital for Active Treatment-Dr. T. Venkova AD
  • Hospital for Active Treatment - Prof.Paraskev Stoyanov AD
  • MHAT Dr. Bratan Shukerov AD
  • MHAT for Women's Health - Nadezhda OOD
  • 900th Hospital of Joint Logistics Support Force
  • Guangzhou Women and Children's Medical Center
  • The Third Affiliated Hospital, Sun Yat-Sen University
  • Boai Hospital of Zhongshan
  • Hainan General Hospital
  • Wuhan Tongji Reproductive Medicine Hospital
  • Nanjing Maternity and Child Health Care Hospital
  • NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
  • Zhongda Hospital Southeast University
  • 1st Affiliated hospital of Soochow University
  • Jiangxi Maternal and Child Health Hospital
  • The Second Affiliated Hospital of Nanchang University
  • The First Hospital of Jilin University
  • The First Affiliated Hospital of Dalian Medical University
  • Shengjing Hospital of China Medical University
  • General Hospital of Ningxia Medical University
  • Second Affiliated Hospital of Xi'an Jiaotong University
  • The First Affiliated Hospital of Xi'an Jiaotong University
  • The Second Affiliated Hospital of Shanxi Medical University
  • The First Affiliated Hospital of Xinjiang Medical University
  • Women's Hospital School of Medicine Zhejiang University
  • Sir Run Run Shaw Hospital, Zhejiang University School of Med
  • The Second Affliated Hospital of Wenzhou Medicial University
  • Beijing Hospital of Traditional Chinese Medicine
  • Peking University First Hospital
  • Beijing Friendship Hospital, Capital Medical University
  • Beijing Tiantan Hospital, Captial Medical University
  • Shanghai East Hospital Affiated to Tongji University
  • Tianjin Medical University General Hospital
  • Gynekologie MEDA s.r.o.
  • Soukroma gynekologicka ambulance
  • Gynekologie Studentsky dum s.r.o.
  • MUDr. Ivana Salamonova s.r.o.
  • Clalit Health Services through HaEmek Medical Center
  • Hillel Yaffe Medical Center
  • Lady Davis Carmel Medical Center
  • Meir Medical Center
  • University Hospital Kebangsaan Malaysia
  • Hospital Wanita dan Kanak-Kanak Sabah
  • Sarawak General Hospital
  • P3 Research Ltd Hawkes Bay
  • P3 Research
  • KK Women's and Children's Hospital
  • Dr L Reynders Practice
  • Wilgeheuwel Hospital
  • Umhlanga Medical Centre
  • Ethekwini Hospital & Heart Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Vilaprisan (A1)

Vilaprisan (A2)

Placebo+Vilaprisan (B1)

Vilaprisan+Placebo (B2)

Arm Description

Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.

Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break.

Placebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode.

Vilaprisan (2 mg) in treatment period 1 for 12 weeks and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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.
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).
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.
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.

Full Information

First Posted
January 5, 2018
Last Updated
April 28, 2023
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT03400943
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 Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to a change in the development program, the study was closed prematurely.
Study Start Date
January 17, 2018 (Actual)
Primary Completion Date
June 9, 2019 (Actual)
Study Completion Date
April 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids
Keywords
Heavy menstrual bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Blinding will be applied to Treatment Groups A1, B1, and B2; Treatment Group A2 will be open-label
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vilaprisan (A1)
Arm Type
Experimental
Arm Description
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Arm Title
Vilaprisan (A2)
Arm Type
Experimental
Arm Description
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break.
Arm Title
Placebo+Vilaprisan (B1)
Arm Type
Experimental
Arm Description
Placebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Arm Title
Vilaprisan+Placebo (B2)
Arm Type
Experimental
Arm Description
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Intervention Type
Drug
Intervention Name(s)
Vilaprisan (BAY1002670)
Intervention Description
2 mg of Vilaprisan once daily up to 2 x 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo was administered to group B1 and B2.
Primary Outcome Measure Information:
Title
Number of Participants With Amenorrhea
Description
Amenorrhea was defined as menstrual blood loss (MBL) <2 mL during the last 28 days of treatment measured by the alkaline hematin (AH) method.
Time Frame
The last 28 days of treatment period 1
Secondary Outcome Measure Information:
Title
Number of Participants With Heavy Menstrual Bleeding (HMB) Response
Description
HMB response was defined as MBL <80 mL during the last 28 days of treatment and >50% reduction from baseline based on AH-method.
Time Frame
The last 28 days of treatment period 1 and treatment period 2
Title
Time to Onset of Amenorrhea
Description
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).
Time Frame
In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)
Title
Time to Onset of Controlled Bleeding
Description
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.
Time Frame
In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)
Title
Number of Participants With Absence of Bleeding (Spotting Allowed)
Description
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).
Time Frame
The last 28 days of treatment period 1 and treatment period 2
Title
Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
Description
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.
Time Frame
Up to 2 weeks after end of treatment
Title
Change From Baseline of Endometrial Thickness
Description
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.
Time Frame
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])

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0026
Country
United States
Facility Name
California Center for Clinical Research
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Facility Name
Core Healthcare Group
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
AVIVA Research
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
National Research Institute - Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Harbor - UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90509-2910
Country
United States
Facility Name
Ideal Clinical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Helix Biomedics, LLC
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Facility Name
Dr. Victoria Garcia & Associates, LLC Doral Medical Research
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Sweet Hope Research Specialty, Inc. - Hialeah
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Altus Research
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Axcess Medical Research, LLC
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
Ocean Blue Medical Research Center, Inc.
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Accelerated Enrollment Solutions a business of PPD
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Facility Name
Discovery Clinical Research
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
ONCOVA Clinical Research, Inc.
City
Saint Cloud
State/Province
Florida
ZIP/Postal Code
34769
Country
United States
Facility Name
Georgia Center For Women
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312
Country
United States
Facility Name
Agile Clinical Research Trials, LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Atlanta Women's Research Institute, Inc. - Alpharetta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Medisense, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30363
Country
United States
Facility Name
Paramount Research Solutions-College Park
City
College Park
State/Province
Georgia
ZIP/Postal Code
30349
Country
United States
Facility Name
One Health Research Clinic
City
Norcross
State/Province
Georgia
ZIP/Postal Code
30093
Country
United States
Facility Name
Fellows Research Alliance - Savannah
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
GTC Research
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66218
Country
United States
Facility Name
Omni Fertility and Laser Institute
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71118
Country
United States
Facility Name
PharmaSite Research, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Simmonds, Martin and Helmbrecht
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20878
Country
United States
Facility Name
Advantia Health, LLC Obstetrics & Gynecology Assoc.
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Carolinas Healthcare System
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Unified Women's Clinical Research - Morehead City
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Eastern Carolina Women's Center
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Wake Research, Inc.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Main Line Fertility Center
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Clinical Research of Philadelphia, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Fellows Research Alliance, Inc.
City
Bluffton
State/Province
South Carolina
ZIP/Postal Code
29910
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Fusion Clinical Research of Spartanburg, LLC
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29301
Country
United States
Facility Name
Chattanooga Medical Research, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Clinical Neurosciences Solutions, Inc DBA CNS Healthcare
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Paramount Research Solutions-Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Health Care, PLLC
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Willowbend Health & Wellness Associates
City
Frisco
State/Province
Texas
ZIP/Postal Code
75035
Country
United States
Facility Name
Family Medicine Clinic
City
Georgetown
State/Province
Texas
ZIP/Postal Code
78626
Country
United States
Facility Name
Biopharma Informatic, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77043
Country
United States
Facility Name
Centex Studies, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
The Center for Clinical Trials, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77082
Country
United States
Facility Name
Houston Center for Clinical Research, LLC
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Millennium Clinical Trials, LLC
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22207
Country
United States
Facility Name
Synexus Research, LLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Multiprofile Hospital for Active Treatment-Dr. T. Venkova AD
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
Facility Name
Hospital for Active Treatment - Prof.Paraskev Stoyanov AD
City
Lovech
ZIP/Postal Code
5500
Country
Bulgaria
Facility Name
MHAT Dr. Bratan Shukerov AD
City
Smolyan
ZIP/Postal Code
4700
Country
Bulgaria
Facility Name
MHAT for Women's Health - Nadezhda OOD
City
Sofia
ZIP/Postal Code
1330
Country
Bulgaria
Facility Name
900th Hospital of Joint Logistics Support Force
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Facility Name
Guangzhou Women and Children's Medical Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510623
Country
China
Facility Name
The Third Affiliated Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Name
Boai Hospital of Zhongshan
City
Zhongshan
State/Province
Guangdong
Country
China
Facility Name
Hainan General Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Facility Name
Wuhan Tongji Reproductive Medicine Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430013
Country
China
Facility Name
Nanjing Maternity and Child Health Care Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210004
Country
China
Facility Name
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
Zhongda Hospital Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
1st Affiliated hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Facility Name
Jiangxi Maternal and Child Health Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Facility Name
The First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110022
Country
China
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Facility Name
Second Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710004
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Name
The Second Affiliated Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Facility Name
The First Affiliated Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China
Facility Name
Women's Hospital School of Medicine Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University School of Med
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
The Second Affliated Hospital of Wenzhou Medicial University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Facility Name
Beijing Hospital of Traditional Chinese Medicine
City
Beijing
ZIP/Postal Code
100010
Country
China
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Beijing Tiantan Hospital, Captial Medical University
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Shanghai East Hospital Affiated to Tongji University
City
Shanghai
ZIP/Postal Code
200123
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Gynekologie MEDA s.r.o.
City
Brno
ZIP/Postal Code
602 00
Country
Czechia
Facility Name
Soukroma gynekologicka ambulance
City
Fulnek
ZIP/Postal Code
74245
Country
Czechia
Facility Name
Gynekologie Studentsky dum s.r.o.
City
Praha 6
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
MUDr. Ivana Salamonova s.r.o.
City
Vysoke Myto
ZIP/Postal Code
566 01
Country
Czechia
Facility Name
Clalit Health Services through HaEmek Medical Center
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
3810101
Country
Israel
Facility Name
Lady Davis Carmel Medical Center
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
University Hospital Kebangsaan Malaysia
City
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
Hospital Wanita dan Kanak-Kanak Sabah
City
Sabah
ZIP/Postal Code
88996
Country
Malaysia
Facility Name
Sarawak General Hospital
City
Sarawak
ZIP/Postal Code
93400
Country
Malaysia
Facility Name
P3 Research Ltd Hawkes Bay
City
Hawkes Bay
ZIP/Postal Code
4130
Country
New Zealand
Facility Name
P3 Research
City
Tauranga
ZIP/Postal Code
3110
Country
New Zealand
Facility Name
KK Women's and Children's Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
Facility Name
Dr L Reynders Practice
City
Lyttelton Manor
State/Province
Gauteng
ZIP/Postal Code
0141
Country
South Africa
Facility Name
Wilgeheuwel Hospital
City
Roodepoort
State/Province
Gauteng
ZIP/Postal Code
1724
Country
South Africa
Facility Name
Umhlanga Medical Centre
City
Durban
State/Province
Kwazulu-Natal
ZIP/Postal Code
4319
Country
South Africa
Facility Name
Ethekwini Hospital & Heart Centre
City
Durban
State/Province
Kwazulu-Natal
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Links:
URL
https://clinicaltrials.bayer.com/
Description
Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Learn more about this trial

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

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