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Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 6)

Primary Purpose

Uterine Fibroids

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vilaprisan (BAY1002670)
Vilaprisan (BAY1002670)
Vilaprisan (BAY1002670)
Standard of care
Vilaprisan (BAY1002670)
Vilaprisan (BAY1002670)
Vilaprisan (BAY1002670)
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 Uterine Fibroid

Eligibility Criteria

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

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

Sites / Locations

  • Central Research Associates, Inc.
  • Women's Health Alliance of Mobile
  • Coastal Clinical Research, Inc
  • Visions Clinical Research - Tucson
  • Lynn Institute of the Ozarks
  • University of Arkansas for Medical Sciences
  • Diagnamics, Inc.
  • Grossmont Center for Clinical Research
  • Womens Health Care Research Corporation
  • Medical Center for Clinical Research
  • West Coast OB/GYN Associates
  • Advanced Women's Health Institute
  • Physicians Research Options, LLC
  • Yale University School of Medicine
  • Stamford Hospital
  • Office of Dr. James A. Simon, MD
  • Helix Biomedics, LLC
  • Women's Medical Research Group, LLC
  • Dr. Victoria Garcia & Associates, LLC Doral Medical Research
  • M & O Clinical Research, LLC
  • Solutions Through Advanced Research, Inc.
  • Axcess Medical Research, LLC
  • Suncoast Clinical Research Center, Inc.
  • Suncoast Clinical Research
  • ONCOVA Clinical Research, Inc.
  • Swor Women's Care
  • Agile Clinical Research Trials, LLC
  • Atlanta Women's Research Institute, Inc. - Atlanta
  • Medisense Inc at Atlantic Station
  • Augusta University Medical Center
  • Paramount Research Solutions-College Park
  • Fellows Research Alliance - Savannah
  • Journey Medical Research
  • Center For Women's Research
  • Professional Research Network of Kansas, LLC
  • Research Integrity, LLC
  • Praetorian Pharmaceutical Research, LLC
  • Southern Clinical Research Associates LLC
  • Omni Fertility and Laser Institute
  • Johns Hopkins University School of Medicine
  • Baltimore Suburban Health, LLC
  • Continental Clinical Solutions, LLC
  • Wayne State University Physicians Group
  • Henry Ford Health System
  • Women's Clinic of Lincoln, PC
  • Wake Research - Clinical Research Center of Nevada, LLC
  • Lawrence OB/GYN Associates
  • Jersey Shore University Medical Center
  • Bosque Womens Care
  • SUNY Downstate Medical Center
  • Manhattan Medical Research
  • Columbia University Medical Center
  • Richmond ObGyn Associates PC
  • Carolinas Healthcare System
  • Carolina Women's Research & Wellness Center
  • Unified Women's Clinical Research - Greensboro
  • Unified Women's Clinical Research - Morehead City
  • Eastern Carolina Women's Center
  • Women's Health Alliance
  • Wake Research, Inc.
  • PMG Research of Wilmington
  • Lyndhurst Clinical Research
  • Valaoras & Lewis OB/GYN
  • Clinical Inquest Center, Ltd.
  • Miami Valley Hospital
  • HWC Women's Research Center
  • Oregon Health and Science University
  • Penn State Milton S. Hershey Medical Center
  • Drexel University College of Medicine
  • Hospital of the University of Pennsylvania
  • Clinical Research of Philadelphia, LLC
  • Medical University of South Carolina
  • Vista Clinical Research
  • VitaLink Research - Greenville
  • Venus Gynecology, LLC former Magnolia OB/GYN Research Center
  • Invocare Clinical Research Center, LLC
  • ClinSearch, LLC
  • Women's Physician Group
  • Discovery Clinical Trials - Dallas
  • Signature GYN Services, Pllc
  • Office of Dr. Delbert Alan Johns, MD
  • Advances in Health, Inc.
  • The Woman's Hospital of Texas
  • Centex Studies, Inc.
  • MacArthur OB/GYN Mangement, LLC
  • Family Medicine Clinic
  • Willowbend Health and Wellness Associates
  • Seven Oaks Women's Center
  • OB-GYN Physicians, Inc.
  • Tidewater Physicians for Women
  • Virginia Physicians For Women
  • Clinical Trials of Viriginia
  • Synexus Research, LLC
  • MultiCare Health Systems Women's Health Care
  • 900th Hospital of Joint Logistics Support Force
  • Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ.
  • The First Affiliated Hospital of Guangzhou University of TCM
  • The Third Affiliated Hospital, Sun Yat-Sen University
  • Peking University Shenzhen Hospital
  • The People's Hospital of Guangxi Zhuang Autonomous Region
  • Hainan General Hospital
  • The 2nd Hospital of Hebei Medical University
  • 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
  • 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
  • Shandong Provincial Hospital
  • The Second Affiliated Hospital of Shanxi Medical University
  • West China Second University Hospital
  • The First Affiliated Hospital of Xinjiang Medical University
  • Women's Hospital School of Medicine Zhejiang University
  • The Second Affliated Hospital of Wenzhou Medicial University
  • Beijing Hospital of Traditional Chinese Medicine
  • Beijing Obstetrics and Gynecology Hospital,Capital Med.Uni.
  • Beijing Tiantan Hospital, Captial Medical University
  • Peking Union Medical College Hospital CAMS
  • Peking University First Hospital
  • International Peace Maternity&Child Health Hospital of CWI
  • Changhai Hospital of Second Military Medical University
  • Tianjin Medical University General Hospital
  • First Teaching Hosptial of Tianjin University of TCM
  • Tianjin Central Hospital of Gynecology obstetrics
  • Fakultni nemocnice Brno
  • Fakultni Nemocnice Hradec Kralove
  • MUDr. Radek Fiker s.r.o.
  • G-Centrum Olomouc s.r.o. Dr. Skrivanek
  • Fakultni Nemocnice Olomouc
  • Centrum gynekologicke rehabilitace
  • Dr. Smrhova-Kovacs
  • MUDr. Pavlina Nejedla s.r.o.
  • Mehiläinen Kuopio
  • Lääkärikeskus Gyneko
  • Queen Mary Hospital
  • Kano's Clinic for Women
  • Kyoritsu Narashinodai Hospital
  • Iryohojinshadan Seijunkai Juno Vesta Clinic Hatta
  • Aso Iizuka Hospital
  • Jusendo Geneal Hospital Yuasa Foundation
  • Sato Hospital
  • Primo Women's Clinic
  • Sapporo Maternity Women's Hospital
  • Sapporo Shiroishi Obstetrics and Gynecology Hospital
  • Hashimoto Clinic
  • Ena Odori Clinic
  • Sapporo Maternity Women's Minami1jo Clinic
  • SAPPORO MEDICAL CENTER, NTT East Corporation
  • Sapporo West Ladies Clinic
  • Yoshio Clinic
  • Ishikawa Prefectural Central Hospital
  • Asahi-Clinic
  • Kagawa Prefectural Central Hospital
  • Second Kawasaki Saiwai Clinic
  • Kurashiki Medical Clinic
  • Suita Municipal Hospital
  • Medical Topia Soka Hospital
  • Fuyo Association Seirei Numazu Hospital
  • Sei Womens Clinic
  • Ginza Yoshida Clinic
  • Women's wellness Tsushima Ruriko josei life clinic Ginza
  • St.Luke's International Hospital
  • Akazawa Clinic
  • Medical Corp. Seikoukai New Medical Research System Clinic
  • Yokokura Clinic
  • Toranomon Womens Clinic
  • Akasakamitsuke Miyazaki Obstetrics and Gynecology Clinic
  • Shirokane Ladies' Clinic
  • Kugayama Hospital
  • Tokyo Women's Medical University Hospital
  • Ikebukuro Metropolitan Clinic
  • Kato Internal medicine and Gynecology Clinic
  • Sano Women's Clinic
  • Unoki Clinic
  • Medical corporation keizukai Chayamachi Ladies Clinic
  • Chayamachi ladies Clinic Hommachi
  • Medical Corporation Koshinkai Nomura Clinic Namba
  • Izuma Clinic
  • Shizuoka Saiseikai General Hospital
  • Shizuoka City Shimizu Hospital
  • Hospital Universitario "José Eleuterio González"
  • Centro Integral Médico de San Juan del Río S. C.
  • Sanatorio Alcocer Pozo S. A. de C. V.
  • Kirkeparken Spesialistpraksis
  • Nesttun Spesialistpraksis AS
  • Medicus AS
  • Prywatna Klinika Ginekologiczno-Poloznicza
  • CLINICAL MEDICAL RESEARCH Sp. z o. o.
  • Vita Longa Sp. z o.o.
  • Gyncentrum Sp. z o.o.
  • Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.
  • Centrum Medyczne Chodzki
  • Specjalistyczny Gabinet Ginekologiczno-Polozniczy
  • Scientific Center of family health & human reprod. problems
  • Regional Clinical Hospital #2
  • Krasnoyarsk regional perinatal center
  • City Clinical Hospital #13 Moscow
  • Endocrinology Research Center
  • Close Joint Stock Company "Medical Company IDK"
  • St. Petersburg Medical University n.a. I.P. Pavlov
  • "Granti-Med"
  • Scien. Res. Institute of Obsterics, Gyn. & Reproduction
  • Dr L Reynders Practice
  • University of Pretoria, Clinical Research Unit
  • Femway Inc
  • Durban International Clinical Research Site
  • Drs AEVITAS Clinic (Pty) Ltd
  • University of Cape Town Clinical Research Centre
  • Clintrials Centre for Clinical Research
  • King Chulalongkorn Memorial Hospital
  • Siriraj Hospital, Mahidol
  • Cukurova Universitesi Tip Fakultesi Hastanesi
  • Ankara Universitesi Tip Fakultesi Hastanesi
  • Etlik Zubeyde Hanim Kadin Hastaliklari Egitim Arastirma Hast
  • Uludag Universitesi Tip Fakultesi
  • Istanbul Universitesi Istanbul Tip Fakultesi
  • Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Other

Arm Label

A1(3/1 regimen)

A2(6/2 regimen)

A3(3/2 regimen)

B(Standard of care)

Arm Description

2.0 mg treatment of 12 weeks, each separated by 1 bleeding break

2.0 mg treatment period of 24 weeks, each separated by 2 bleeding break

2.0 mg treatment period of 12 weeks, each separated by 2 bleeding break

Standard of care as determined by the investigators, this could be watch & wait or non-hormonal medical treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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.
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.

Full Information

First Posted
June 20, 2017
Last Updated
September 27, 2023
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT03194646
Brief Title
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 30, 2017 (Actual)
Primary Completion Date
May 10, 2019 (Actual)
Study Completion Date
June 30, 2024 (Anticipated)

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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1272 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A1(3/1 regimen)
Arm Type
Experimental
Arm Description
2.0 mg treatment of 12 weeks, each separated by 1 bleeding break
Arm Title
A2(6/2 regimen)
Arm Type
Experimental
Arm Description
2.0 mg treatment period of 24 weeks, each separated by 2 bleeding break
Arm Title
A3(3/2 regimen)
Arm Type
Experimental
Arm Description
2.0 mg treatment period of 12 weeks, each separated by 2 bleeding break
Arm Title
B(Standard of care)
Arm Type
Other
Arm Description
Standard of care as determined by the investigators, this could be watch & wait or non-hormonal medical treatment
Intervention Type
Drug
Intervention Name(s)
Vilaprisan (BAY1002670)
Intervention Description
2 mg of Vilaprisan once daily for 12 weeks, 4 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen).
Intervention Type
Drug
Intervention Name(s)
Vilaprisan (BAY1002670)
Intervention Description
2 mg of Vilaprisan once daily for 24 weeks, 2 treatment periods of 24 weeks, each separated by 2 bleeding episodes (6/2 regimen).
Intervention Type
Drug
Intervention Name(s)
Vilaprisan (BAY1002670)
Intervention Description
2 mg of Vilaprisan once daily for 12 weeks, 4 treatment periods of 12 weeks, each separated by 2 bleeding episodes (3/2 regimen).
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Standard of care as determined by the investigators (including watch and wait, symptomatic nonhormonal)
Intervention Type
Drug
Intervention Name(s)
Vilaprisan (BAY1002670)
Intervention Description
2 mg of Vilaprisan once daily for 12 weeks, 8 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen)
Intervention Type
Drug
Intervention Name(s)
Vilaprisan (BAY1002670)
Intervention Description
2 mg of Vilaprisan once daily for 24 weeks, 4 treatment periods of 24 weeks, each separated by 2 bleeding episodes (6/2 regimen)
Intervention Type
Drug
Intervention Name(s)
Vilaprisan (BAY1002670)
Intervention Description
2 mg of Vilaprisan once daily for 12 weeks, 6 treatment periods of 12 weeks, each separated by 2 bleeding episodes (3/2 regimen)
Primary Outcome Measure Information:
Title
Percentage Change in Bone Mineral Density (BMD) of Lumbar Spine
Description
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.
Time Frame
From baseline to about 1 year after start of treatment
Secondary Outcome Measure Information:
Title
Number of Bleeding Days
Description
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
Time Frame
Treatment phase: approximately 1 year
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, presence or absence of hyperplasia or malignancy
Time Frame
Up to 3 years (from study treatment start to end of study)
Title
Change From Baseline in 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 (worst measurement during baseline period) in endometrial thickness was provided in below table.
Time Frame
Treatment phase: approximately 1 year, follow-up phase: up to 2 years
Title
Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck
Description
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.
Time Frame
Treatment phase: approximately 1 year, follow-up phase: up to 2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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
Central Research Associates, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Women's Health Alliance of Mobile
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Coastal Clinical Research, Inc
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Visions Clinical Research - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Lynn Institute of the Ozarks
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Diagnamics, Inc.
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
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
Womens Health Care Research Corporation
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
Medical Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
West Coast OB/GYN Associates
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Advanced Women's Health Institute
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
Physicians Research Options, LLC
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Stamford Hospital
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06904
Country
United States
Facility Name
Office of Dr. James A. Simon, MD
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
Helix Biomedics, LLC
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
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
Dr. Victoria Garcia & Associates, LLC Doral Medical Research
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
M & O Clinical Research, LLC
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Solutions Through Advanced Research, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Axcess Medical Research, LLC
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
Suncoast Clinical Research Center, Inc.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Suncoast Clinical Research
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
ONCOVA Clinical Research, Inc.
City
Saint Cloud
State/Province
Florida
ZIP/Postal Code
34769
Country
United States
Facility Name
Swor Women's Care
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
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. - Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Medisense Inc at Atlantic Station
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30364
Country
United States
Facility Name
Augusta University Medical Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
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
Fellows Research Alliance - Savannah
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Journey Medical Research
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Center For Women's Research
City
Palos Heights
State/Province
Illinois
ZIP/Postal Code
60463
Country
United States
Facility Name
Professional Research Network of Kansas, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205-1138
Country
United States
Facility Name
Research Integrity, LLC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Praetorian Pharmaceutical Research, LLC
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Southern Clinical Research Associates LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
Omni Fertility and Laser Institute
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71118
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Baltimore Suburban Health, LLC
City
Pikesville
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Continental Clinical Solutions, LLC
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Wayne State University Physicians Group
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Women's Clinic of Lincoln, PC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Wake Research - Clinical Research Center of Nevada, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Lawrence OB/GYN Associates
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Bosque Womens Care
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Manhattan Medical Research
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Richmond ObGyn Associates PC
City
Staten Island
State/Province
New York
ZIP/Postal Code
10306
Country
United States
Facility Name
Carolinas Healthcare System
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Carolina Women's Research & Wellness Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
Unified Women's Clinical Research - Greensboro
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
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
Women's Health Alliance
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Wake Research, Inc.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
PMG Research of Wilmington
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Lyndhurst Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Valaoras & Lewis OB/GYN
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Clinical Inquest Center, Ltd.
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409-2793
Country
United States
Facility Name
HWC Women's Research Center
City
Englewood
State/Province
Ohio
ZIP/Postal Code
45322
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Clinical Research of Philadelphia, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
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
Vista Clinical Research
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
VitaLink Research - Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Venus Gynecology, LLC former Magnolia OB/GYN Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Invocare Clinical Research Center, LLC
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
ClinSearch, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Women's Physician Group
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Discovery Clinical Trials - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Signature GYN Services, Pllc
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104-4145
Country
United States
Facility Name
Office of Dr. Delbert Alan Johns, MD
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Advances in Health, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Woman's Hospital of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Centex Studies, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
MacArthur OB/GYN Mangement, LLC
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Facility Name
Family Medicine Clinic
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550
Country
United States
Facility Name
Willowbend Health and Wellness Associates
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Seven Oaks Women's Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
OB-GYN Physicians, Inc.
City
Franklin
State/Province
Virginia
ZIP/Postal Code
23851
Country
United States
Facility Name
Tidewater Physicians for Women
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Virginia Physicians For Women
City
North Chesterfield
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Clinical Trials of Viriginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
Synexus Research, LLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
MultiCare Health Systems Women's Health Care
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98402
Country
United States
Facility Name
900th Hospital of Joint Logistics Support Force
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Facility Name
Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ.
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou University of TCM
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510405
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
Peking University Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518036
Country
China
Facility Name
The People's Hospital of Guangxi Zhuang Autonomous Region
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Hainan General Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Facility Name
The 2nd Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
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
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
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
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
West China Second University Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
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
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
Beijing Obstetrics and Gynecology Hospital,Capital Med.Uni.
City
Beijing
ZIP/Postal Code
100026
Country
China
Facility Name
Beijing Tiantan Hospital, Captial Medical University
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Peking Union Medical College Hospital CAMS
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Peking University First Hospital
City
Beijing
Country
China
Facility Name
International Peace Maternity&Child Health Hospital of CWI
City
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Changhai Hospital of Second Military Medical University
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
First Teaching Hosptial of Tianjin University of TCM
City
Tianjin
ZIP/Postal Code
300193
Country
China
Facility Name
Tianjin Central Hospital of Gynecology obstetrics
City
Tianjin
ZIP/Postal Code
300199
Country
China
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni Nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
Facility Name
MUDr. Radek Fiker s.r.o.
City
Jihlava
ZIP/Postal Code
586 01
Country
Czechia
Facility Name
G-Centrum Olomouc s.r.o. Dr. Skrivanek
City
Olomouc
ZIP/Postal Code
772 00
Country
Czechia
Facility Name
Fakultni Nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Facility Name
Centrum gynekologicke rehabilitace
City
Pisek
ZIP/Postal Code
39701
Country
Czechia
Facility Name
Dr. Smrhova-Kovacs
City
Tabor
ZIP/Postal Code
39003
Country
Czechia
Facility Name
MUDr. Pavlina Nejedla s.r.o.
City
Vodnany
ZIP/Postal Code
389 01
Country
Czechia
Facility Name
Mehiläinen Kuopio
City
Kuopio
ZIP/Postal Code
70100
Country
Finland
Facility Name
Lääkärikeskus Gyneko
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
Queen Mary Hospital
City
Hongkong
Country
Hong Kong
Facility Name
Kano's Clinic for Women
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0011
Country
Japan
Facility Name
Kyoritsu Narashinodai Hospital
City
Funabashi
State/Province
Chiba
ZIP/Postal Code
274-0063
Country
Japan
Facility Name
Iryohojinshadan Seijunkai Juno Vesta Clinic Hatta
City
Matsudo
State/Province
Chiba
ZIP/Postal Code
270-2267
Country
Japan
Facility Name
Aso Iizuka Hospital
City
Iizuka
State/Province
Fukuoka
ZIP/Postal Code
820-8505
Country
Japan
Facility Name
Jusendo Geneal Hospital Yuasa Foundation
City
Koriyama
State/Province
Fukushima
ZIP/Postal Code
963-8585
Country
Japan
Facility Name
Sato Hospital
City
Takasaki
State/Province
Gunma
ZIP/Postal Code
370-0836
Country
Japan
Facility Name
Primo Women's Clinic
City
Ebetsu
State/Province
Hokkaido
ZIP/Postal Code
067-0031
Country
Japan
Facility Name
Sapporo Maternity Women's Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
001-0013
Country
Japan
Facility Name
Sapporo Shiroishi Obstetrics and Gynecology Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0005
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
Sapporo Maternity Women's Minami1jo Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0061
Country
Japan
Facility Name
SAPPORO MEDICAL CENTER, NTT East Corporation
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0061
Country
Japan
Facility Name
Sapporo West Ladies Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
063-0061
Country
Japan
Facility Name
Yoshio Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
064-0808
Country
Japan
Facility Name
Ishikawa Prefectural Central Hospital
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8530
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
Second Kawasaki Saiwai Clinic
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
212-0021
Country
Japan
Facility Name
Kurashiki Medical Clinic
City
Kurashiki
State/Province
Okayama
ZIP/Postal Code
710-0824
Country
Japan
Facility Name
Suita Municipal Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
564-0082
Country
Japan
Facility Name
Medical Topia Soka Hospital
City
Soka
State/Province
Saitama
ZIP/Postal Code
340-0028
Country
Japan
Facility Name
Fuyo Association Seirei Numazu Hospital
City
Numazu
State/Province
Shizuoka
ZIP/Postal Code
410-8555
Country
Japan
Facility Name
Sei Womens Clinic
City
Bunkyo
State/Province
Tokyo
ZIP/Postal Code
112-0014
Country
Japan
Facility Name
Ginza Yoshida Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0061
Country
Japan
Facility Name
Women's wellness Tsushima Ruriko josei life clinic Ginza
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0061
Country
Japan
Facility Name
St.Luke's International Hospital
City
Chuoku
State/Province
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Akazawa Clinic
City
Fuchu
State/Province
Tokyo
ZIP/Postal Code
183-0056
Country
Japan
Facility Name
Medical Corp. Seikoukai New Medical Research System Clinic
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
192-0046
Country
Japan
Facility Name
Yokokura Clinic
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-0014
Country
Japan
Facility Name
Toranomon Womens Clinic
City
Minato
State/Province
Tokyo
ZIP/Postal Code
105-0001
Country
Japan
Facility Name
Akasakamitsuke Miyazaki Obstetrics and Gynecology Clinic
City
Minato
State/Province
Tokyo
ZIP/Postal Code
107-0051
Country
Japan
Facility Name
Shirokane Ladies' Clinic
City
Minato
State/Province
Tokyo
ZIP/Postal Code
108-0071
Country
Japan
Facility Name
Kugayama Hospital
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
157-0061
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Ikebukuro Metropolitan Clinic
City
Toshima-ku
State/Province
Tokyo
ZIP/Postal Code
171-0021
Country
Japan
Facility Name
Kato Internal medicine and Gynecology Clinic
City
Fukui
ZIP/Postal Code
910-0845
Country
Japan
Facility Name
Sano Women's Clinic
City
Fukuoka
ZIP/Postal Code
810-0062
Country
Japan
Facility Name
Unoki Clinic
City
Kagoshima
ZIP/Postal Code
892-0826
Country
Japan
Facility Name
Medical corporation keizukai Chayamachi Ladies Clinic
City
Osaka
ZIP/Postal Code
530-0013
Country
Japan
Facility Name
Chayamachi ladies Clinic Hommachi
City
Osaka
ZIP/Postal Code
541-0048
Country
Japan
Facility Name
Medical Corporation Koshinkai Nomura Clinic Namba
City
Osaka
ZIP/Postal Code
542-0076
Country
Japan
Facility Name
Izuma Clinic
City
Osaka
ZIP/Postal Code
543-0023
Country
Japan
Facility Name
Shizuoka Saiseikai General Hospital
City
Shizuoka
ZIP/Postal Code
422-8527
Country
Japan
Facility Name
Shizuoka City Shimizu Hospital
City
Shizuoka
ZIP/Postal Code
424-8636
Country
Japan
Facility Name
Hospital Universitario "José Eleuterio González"
City
Monterrey
State/Province
Nuevo Leon
Country
Mexico
Facility Name
Centro Integral Médico de San Juan del Río S. C.
City
San Juan del Río
State/Province
Querétaro
ZIP/Postal Code
76800
Country
Mexico
Facility Name
Sanatorio Alcocer Pozo S. A. de C. V.
City
Querétaro
ZIP/Postal Code
76000
Country
Mexico
Facility Name
Kirkeparken Spesialistpraksis
City
Fredrikstad
ZIP/Postal Code
1605
Country
Norway
Facility Name
Nesttun Spesialistpraksis AS
City
Nesttun
ZIP/Postal Code
5221
Country
Norway
Facility Name
Medicus AS
City
Trondheim
ZIP/Postal Code
7014
Country
Norway
Facility Name
Prywatna Klinika Ginekologiczno-Poloznicza
City
Bialystok
ZIP/Postal Code
15-244
Country
Poland
Facility Name
CLINICAL MEDICAL RESEARCH Sp. z o. o.
City
Katowice
ZIP/Postal Code
40-156
Country
Poland
Facility Name
Vita Longa Sp. z o.o.
City
Katowice
ZIP/Postal Code
40-748
Country
Poland
Facility Name
Gyncentrum Sp. z o.o.
City
Katowice
ZIP/Postal Code
40-851
Country
Poland
Facility Name
Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.
City
Lodz
ZIP/Postal Code
90-602
Country
Poland
Facility Name
Centrum Medyczne Chodzki
City
Lublin
ZIP/Postal Code
20-093
Country
Poland
Facility Name
Specjalistyczny Gabinet Ginekologiczno-Polozniczy
City
Lublin
ZIP/Postal Code
20-400
Country
Poland
Facility Name
Scientific Center of family health & human reprod. problems
City
Irkutsk
ZIP/Postal Code
664003
Country
Russian Federation
Facility Name
Regional Clinical Hospital #2
City
Krasnodar
ZIP/Postal Code
350012
Country
Russian Federation
Facility Name
Krasnoyarsk regional perinatal center
City
Krasnoyarsk
ZIP/Postal Code
660074
Country
Russian Federation
Facility Name
City Clinical Hospital #13 Moscow
City
Moscow
ZIP/Postal Code
115280
Country
Russian Federation
Facility Name
Endocrinology Research Center
City
Moscow
ZIP/Postal Code
117036
Country
Russian Federation
Facility Name
Close Joint Stock Company "Medical Company IDK"
City
Samara
ZIP/Postal Code
443067
Country
Russian Federation
Facility Name
St. Petersburg Medical University n.a. I.P. Pavlov
City
St. Petersburg
ZIP/Postal Code
197022
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
Dr L Reynders Practice
City
Lyttelton Manor
State/Province
Gauteng
ZIP/Postal Code
0141
Country
South Africa
Facility Name
University of Pretoria, Clinical Research Unit
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Femway Inc
City
Umhlanga
State/Province
Kwazulu-Natal
ZIP/Postal Code
4321
Country
South Africa
Facility Name
Durban International Clinical Research Site
City
Wentworth
State/Province
Kwazulu-Natal
ZIP/Postal Code
4052
Country
South Africa
Facility Name
Drs AEVITAS Clinic (Pty) Ltd
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7405
Country
South Africa
Facility Name
University of Cape Town Clinical Research Centre
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Clintrials Centre for Clinical Research
City
Panorama
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Siriraj Hospital, Mahidol
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Cukurova Universitesi Tip Fakultesi Hastanesi
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Facility Name
Ankara Universitesi Tip Fakultesi Hastanesi
City
Ankara
ZIP/Postal Code
6100
Country
Turkey
Facility Name
Etlik Zubeyde Hanim Kadin Hastaliklari Egitim Arastirma Hast
City
Ankara
Country
Turkey
Facility Name
Uludag Universitesi Tip Fakultesi
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Facility Name
Istanbul Universitesi Istanbul Tip Fakultesi
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey

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.

Learn more about this trial

Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

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