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Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)

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 more than 30 mm and less than 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 the 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 months since delivery, abortion, or lactation before start of treatment)
  • Hypersensitivity to any ingredient of the study drug
  • Hemoglobin values ≤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values ≤10.9 g/dL will be recommended to use iron supplementation)
  • 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 (e.g. laxatives)
  • Use of other treatments that might interfere with the conduct of the study or the interpretation of results
  • Undiagnosed abnormal genital bleeding

Sites / Locations

  • Clearview Medical Research, LLC
  • Diagnamics, Inc.
  • National Research Institute
  • Grossmont Center for Clinical Research
  • West Coast OB/GYN Associates
  • National Research Institute
  • Artemis Institute for Clinical Research
  • Medical Center for Clinical Research
  • Women's Medical Research Group, LLC
  • Vital Pharma Research
  • Solutions Through Advanced Research, Inc.
  • Health Awareness, Inc.
  • South Florida Clinical Research Institute
  • Savin Medical Group LLC
  • Suncoast Research Group, LLC
  • Advanced Pharma CR, LLC
  • Genoma Research Group, Inc.
  • Florida Research Center, Inc.
  • Miami Dade Medical Research Institute, LLC
  • Vista Health Research
  • Palmetto Professional Research
  • A Premier Medical Research of Florida, LLC
  • Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare
  • Oviedo Medical Research, LLC
  • DMI Research
  • Physician Care Clinical Research
  • Journey Medical Research
  • Women's Healthcare Associates, PA
  • New England Center for Clinical Research, Inc.
  • Altea Research Institute
  • Unified Women's Clinical Research
  • PMG Research of Wilmington
  • Unified Women's Clinical Research / Ocala, FL
  • Oregon Health and Science University
  • The Clinical Trial Center, LLC
  • University of Pennsylvania
  • Vista Clinical Research
  • Chattanooga Women for Women
  • Women Partners in Health Obstetrics & Gynecology (OB/GYN)
  • Gadolin Research
  • Discovery Clinical Trials
  • Advances in Health, Inc.
  • Discovery Clinical Trials
  • Center of Reproductive Medicine
  • Tidewater Physicians for Women
  • Seattle Clinical Research Center
  • GynPorCentrum s.r.o.
  • Gynekologie MUDr. Jaromir Karban s.r.o
  • Privatni gynekologicko-porodnicka ordinace
  • GYNEVI s.r.o.
  • Gynekologicka ambulance - Zabreh na Morave
  • Funabashi Municipal Medical Center
  • Tsujinaka Hospital Kashiwanoha
  • Matsudo City General Hospital
  • Hashimoto Clinic
  • Ena Odori Clinic
  • Tokeidai Memorial Clinic
  • Yoshio Clinic
  • Kosumo Clinic
  • Kobe City Medical Center General Hospital
  • Takamatsu Red Cross Hospital
  • Asahi-Clinic.
  • Kagawa Prefectural Central Hospital
  • Shonan Fujisawa Tokushukai Hospital
  • Kyoto city Hospital
  • Medical Topia Soka Hospital
  • Omi Medical Center
  • Saiseikai Fukuoka General Hospital
  • Unoki Clinic
  • Tetsu-Nakamura Obstetrics and Gynecology Internal Medicine
  • Four Seasons Ladies' Clinic
  • Japanese Red Cross Kumamoto Hospital
  • Ijinkai Takeda General Hospital
  • Japanese Red Cross Kyoto Daini Hospital
  • Gokeikai Osaka Kaisei Hospital
  • Osaka City Hospital Organization Osaka City General Hospital
  • Medical Co. LEADING GIRLS Women's Clinic LUNA Shinsaibashi
  • Altai State Medical University
  • Maternity Hospital, 17
  • Close Joint Stock Company "Medical Company IDK"
  • Smolensk State Medical University
  • Med Estetic Center
  • "Granti-Med"
  • Scien. Res. Institute of Obsterics, Gyn. & Reproduction
  • Chernivtsi Regional Perinatal Center
  • Vinnytsia City Clinical Maternity Hospital No 2
  • Zaporizhzhia Regional Clinical Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Vilaprisan (A1)

Placebo+Vilaprisan (B1)

Vilaprisan+Placebo (B2)

Arm Description

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

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

Vilaprisan 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. The evaluation of MBL was based on the Alkaline hematin (AH) method.

Secondary Outcome Measures

Number of Participants With Heavy Menstrual Bleeding (HMB) Response
HMB was defined as MBL <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline (assessed by the 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 and assessed by the AH method).
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 (assessed by the 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 UF-DBD (Uterine Fibroid Daily Bleeding Diary).
Number of Participants by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
Number of participants with endometrial histology findings, e.g. benign endometrium, malignant neoplasm, hyperplasia without atypia, hyperplasia with 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
June 29, 2022
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT03400956
Brief Title
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)
Official Title
A Randomized, Parallel-group, Double-blind and 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
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to a change in the development program, the study was closed prematurely.
Study Start Date
January 24, 2018 (Actual)
Primary Completion Date
March 23, 2019 (Actual)
Study Completion Date
June 30, 2021 (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 of vilaprisan in the treatment of heavy menstrual bleeding (HMB) 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
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vilaprisan (A1)
Arm Type
Experimental
Arm Description
Vilaprisan in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Arm Title
Placebo+Vilaprisan (B1)
Arm Type
Experimental
Arm Description
Placebo in treatment period 1 for 12 weeks, and vilaprisan in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Arm Title
Vilaprisan+Placebo (B2)
Arm Type
Experimental
Arm Description
Vilaprisan 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
Orally, coated tablet 2 mg, once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Orally, coated tablet, once daily
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. The evaluation of MBL was based on 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 was defined as MBL <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline (assessed by the 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 and assessed by the AH method).
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 (assessed by the 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 UF-DBD (Uterine Fibroid Daily Bleeding Diary).
Time Frame
The last 28 days of treatment period 1 and treatment period 2
Title
Number of Participants by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
Description
Number of participants with endometrial histology findings, e.g. benign endometrium, malignant neoplasm, hyperplasia without atypia, hyperplasia with atypia and endometrial polyps.
Time Frame
Up to 36 weeks
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
In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)

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 more than 30 mm and less than 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 the 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 months since delivery, abortion, or lactation before start of treatment) Hypersensitivity to any ingredient of the study drug Hemoglobin values ≤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values ≤10.9 g/dL will be recommended to use iron supplementation) 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 (e.g. laxatives) Use of other treatments that might interfere with the conduct of the study or the interpretation of 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
Clearview Medical Research, LLC
City
Canyon Country
State/Province
California
ZIP/Postal Code
91351
Country
United States
Facility Name
Diagnamics, Inc.
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
National Research Institute
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
Grossmont Center for Clinical Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
West Coast OB/GYN Associates
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
National Research Institute
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Medical Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Women's Medical Research Group, LLC
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
Vital Pharma Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Solutions Through Advanced Research, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Health Awareness, Inc.
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
South Florida Clinical Research Institute
City
Margate
State/Province
Florida
ZIP/Postal Code
33073
Country
United States
Facility Name
Savin Medical Group LLC
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Suncoast Research Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Advanced Pharma CR, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33147
Country
United States
Facility Name
Genoma Research Group, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Florida Research Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
Miami Dade Medical Research Institute, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Vista Health Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Palmetto Professional Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
A Premier Medical Research of Florida, LLC
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Oviedo Medical Research, LLC
City
Oviedo
State/Province
Florida
ZIP/Postal Code
32765
Country
United States
Facility Name
DMI Research
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
Country
United States
Facility Name
Physician Care Clinical Research
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Journey Medical Research
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Women's Healthcare Associates, PA
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
New England Center for Clinical Research, Inc.
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Altea Research Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Unified Women's Clinical Research
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
PMG Research of Wilmington
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Unified Women's Clinical Research / Ocala, FL
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3011
Country
United States
Facility Name
The Clinical Trial Center, LLC
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Vista Clinical Research
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Chattanooga Women for Women
City
Hixson
State/Province
Tennessee
ZIP/Postal Code
37343
Country
United States
Facility Name
Women Partners in Health Obstetrics & Gynecology (OB/GYN)
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Gadolin Research
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Discovery Clinical Trials
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Advances in Health, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Discovery Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Center of Reproductive Medicine
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Tidewater Physicians for Women
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Seattle Clinical Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
GynPorCentrum s.r.o.
City
Krnov
ZIP/Postal Code
794 01
Country
Czechia
Facility Name
Gynekologie MUDr. Jaromir Karban s.r.o
City
Neratovice
ZIP/Postal Code
277 11
Country
Czechia
Facility Name
Privatni gynekologicko-porodnicka ordinace
City
Praha
ZIP/Postal Code
16000
Country
Czechia
Facility Name
GYNEVI s.r.o.
City
Rokycany
ZIP/Postal Code
337 01
Country
Czechia
Facility Name
Gynekologicka ambulance - Zabreh na Morave
City
Zabreh Na Morave
ZIP/Postal Code
78901
Country
Czechia
Facility Name
Funabashi Municipal Medical Center
City
Funabashi
State/Province
Chiba
ZIP/Postal Code
273-8588
Country
Japan
Facility Name
Tsujinaka Hospital Kashiwanoha
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-0871
Country
Japan
Facility Name
Matsudo City General Hospital
City
Matsudo
State/Province
Chiba
ZIP/Postal Code
270-2296
Country
Japan
Facility Name
Hashimoto Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
004-0052
Country
Japan
Facility Name
Ena Odori Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0001
Country
Japan
Facility Name
Tokeidai Memorial Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0031
Country
Japan
Facility Name
Yoshio Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
064-0808
Country
Japan
Facility Name
Kosumo Clinic
City
Kako-gun
State/Province
Hyogo
ZIP/Postal Code
675-1115
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Takamatsu Red Cross Hospital
City
Takamatsu
State/Province
Kagawa
ZIP/Postal Code
760-0017
Country
Japan
Facility Name
Asahi-Clinic.
City
Takamatsu
State/Province
Kagawa
ZIP/Postal Code
760-0076
Country
Japan
Facility Name
Kagawa Prefectural Central Hospital
City
Takamatsu
State/Province
Kagawa
ZIP/Postal Code
760-8557
Country
Japan
Facility Name
Shonan Fujisawa Tokushukai Hospital
City
Fujisawa
State/Province
Kanagawa
ZIP/Postal Code
251-0041
Country
Japan
Facility Name
Kyoto city Hospital
City
Nakagyo-ku
State/Province
Kyoto
ZIP/Postal Code
604-8845
Country
Japan
Facility Name
Medical Topia Soka Hospital
City
Soka
State/Province
Saitama
ZIP/Postal Code
340-0028
Country
Japan
Facility Name
Omi Medical Center
City
Kusatsu
State/Province
Shiga
ZIP/Postal Code
525-8585
Country
Japan
Facility Name
Saiseikai Fukuoka General Hospital
City
Fukuoka
ZIP/Postal Code
810-0001
Country
Japan
Facility Name
Unoki Clinic
City
Kagoshima
ZIP/Postal Code
892-0826
Country
Japan
Facility Name
Tetsu-Nakamura Obstetrics and Gynecology Internal Medicine
City
Kagoshima
ZIP/Postal Code
892-0845
Country
Japan
Facility Name
Four Seasons Ladies' Clinic
City
Kumamoto
ZIP/Postal Code
860-0846
Country
Japan
Facility Name
Japanese Red Cross Kumamoto Hospital
City
Kumamoto
ZIP/Postal Code
861-8520
Country
Japan
Facility Name
Ijinkai Takeda General Hospital
City
Kyoto
ZIP/Postal Code
601-1495
Country
Japan
Facility Name
Japanese Red Cross Kyoto Daini Hospital
City
Kyoto
ZIP/Postal Code
602-8026
Country
Japan
Facility Name
Gokeikai Osaka Kaisei Hospital
City
Osaka
ZIP/Postal Code
532-0003
Country
Japan
Facility Name
Osaka City Hospital Organization Osaka City General Hospital
City
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
Medical Co. LEADING GIRLS Women's Clinic LUNA Shinsaibashi
City
Osaka
ZIP/Postal Code
542-0086
Country
Japan
Facility Name
Altai State Medical University
City
Barnaul
ZIP/Postal Code
656038
Country
Russian Federation
Facility Name
Maternity Hospital, 17
City
Saint-Petersburg
ZIP/Postal Code
192174
Country
Russian Federation
Facility Name
Close Joint Stock Company "Medical Company IDK"
City
Samara
ZIP/Postal Code
443067
Country
Russian Federation
Facility Name
Smolensk State Medical University
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Med Estetic Center
City
St. Petersburg
ZIP/Postal Code
192177
Country
Russian Federation
Facility Name
"Granti-Med"
City
St. Petersburg
ZIP/Postal Code
198329
Country
Russian Federation
Facility Name
Scien. Res. Institute of Obsterics, Gyn. & Reproduction
City
St. Petersburg
ZIP/Postal Code
199034
Country
Russian Federation
Facility Name
Chernivtsi Regional Perinatal Center
City
Chernivtsi
ZIP/Postal Code
58001
Country
Ukraine
Facility Name
Vinnytsia City Clinical Maternity Hospital No 2
City
Vinnytsia
ZIP/Postal Code
21001
Country
Ukraine
Facility Name
Zaporizhzhia Regional Clinical Hospital
City
Zaporizhzhya
ZIP/Postal Code
69103
Country
Ukraine

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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
Links:
URL
https://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer products
URL
https://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 4)

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