Back to resultsBay98-7196, Dose Finding / POC Study
Primary Purpose
Endometriosis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Levonorgestrel
Anastrozole
Lupron / Leuprolide acetate
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis
Eligibility Criteria
Inclusion Criteria:
- Premenopausal women18 years and above at the time of screening.
- Women with endometriosis confirmed by laparoscopy or laparotomy within the last ten years but not less than 8 weeks before the screening visit In Japan, diagnosis based on imaging (transvaginal ultrasound or MRI) also qualifies for inclusion.
- Moderate to severe endometriosis-associated pelvic pain (EAPP) of ≥5 in the last 28 days before screening visit 1 measured on the numeric rating scale (NRS; i.e. 4-week recall period).
- At randomization: Adherence to the study procedures during the screening period, at least 24 diary entries of ESD item 1 during the last 28 consecutive days before the randomization visit, and a sum of the available ESD item 1 ('worst pain' on the daily NRS) entries during this period of at least 98 (corresponding to an average score of ≥ 3.5).
- Willingness to use only ibuprofen as rescue pain medication for EAPP, if needed according to investigator's instruction.
- Use of a non-hormonal barrier method (i.e. spermicide-coated condoms) for contraception from screening visit until the end of the study. This is not required if adequate contraception is achieved by vasectomy of the partner
Exclusion Criteria:
- Pregnancy or lactation (less than three months since delivery, abortion, or lactation before start of treatment)
- Any diseases or conditions 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.
- Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator.
- Undiagnosed abnormal genital bleeding
- Wish for pregnancy during the study
- Regular use of pain medication due to other underlying diseases
- Non-responsiveness of endometriosis associated pelvic pain (EAPP) to GnRH-a or surgery (partial response is not exclusionary).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Placebo
Levonorgestrel
Anastrozole 300 µg/d + Levonorgestrel
Anastrozole 600 µg/d + Levonorgestrel
Anastrozole 1050 µg/d + Levonorgestrel
Lupron / Leuprolide acetate
Arm Description
Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Anastrozole 300 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Anastrozole 600 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Anastrozole 1050 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Lupron / Leuprolide acetate 11.25 mg 3-months depot intramuscular injection
Outcomes
Primary Outcome Measures
Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to End of Treatment (Last 28 Days of Treatment Period, Days 57-84) as Measured on NRS by Question 1 of ESD
Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain of the 7 days with worst EAPP within a 28-day window was calculated as the sum of ESD item 1 on 7 days with worst EAPP within that 28-day window divided by 7.
Secondary Outcome Measures
Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment (Day 1-28) and to Second Cycle Under Study Treatment (Day 29-56) as Measured on NRS by Question 1 of ESD
Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain of the 7 days with worst EAPP within a 28-day window was calculated as the sum of ESD item 1 on 7 days with worst EAPP within that 28-day window divided by 7.
Absolute Change in Mean Pain From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment(Day1-28), Second Cycle Under Study Treatment(Day29-56),Third Cycle Under Study Treatment (Day57-84) as Measured on NRS by Question1 of ESD
Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain within a 28-day window was calculated as the sum of ESD item 1 within that 28-day window divided by the number with non-missing days within that 28-day window. Here, number of subjects 'n' signifies evaluable subjects for the respective category.
Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain Greater Than or Equal to (>=) 7 as Measured on NRS by Question 1 of ESD as Measured on NRS by Question 1 of ESD
Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain >=7 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that 28-day window where item 1 of the ESD was >=7.
Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain >=7 as Measured on NRS by Question 1 of ESD
Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain >=7 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that 28-day window where item 1 of the ESD was >=7. Here, number of subjects 'n' signifies evaluable subjects for the respective category.
Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain >=4 as Measured on NRS by Question 1 of ESD
Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain >=4 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that window where Item 1 of the ESD was >=4. Here, number of subjects 'n' signifies evaluable subjects for the respective category.
Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain >=4 as Measured on NRS by Question 1 of ESD
Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain >=4 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that window where Item 1 of the ESD was >=4. Here, number of subjects 'n' signifies evaluable subjects for the respective category.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02203331
Brief Title
Bay98-7196, Dose Finding / POC Study
Official Title
A Randomized, Double-blind, Double-dummy, Parallel- Group, Multi-center Phase IIb Study to Assess the Efficacy and Safety of Different Dose Combinations of an Aromatase Inhibitor and a Progestin in an Intravaginal Ring Versus Placebo and Leuprorelin / Leuprolide Acetate in Women With Symptomatic Endometriosis Over a 12-week Treatment Period
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
October 16, 2014 (Actual)
Primary Completion Date
October 24, 2016 (Actual)
Study Completion Date
October 24, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Purpose of the study is to test efficacy and safety of BAY98-7196 intravaginal ring as a new treatment option for patients with endometriosis-associated pelvic pain
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
319 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Arm Title
Levonorgestrel
Arm Type
Experimental
Arm Description
Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Arm Title
Anastrozole 300 µg/d + Levonorgestrel
Arm Type
Experimental
Arm Description
Anastrozole 300 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Arm Title
Anastrozole 600 µg/d + Levonorgestrel
Arm Type
Experimental
Arm Description
Anastrozole 600 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Arm Title
Anastrozole 1050 µg/d + Levonorgestrel
Arm Type
Experimental
Arm Description
Anastrozole 1050 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Arm Title
Lupron / Leuprolide acetate
Arm Type
Active Comparator
Arm Description
Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Lupron / Leuprolide acetate 11.25 mg 3-months depot intramuscular injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Intervention Type
Drug
Intervention Name(s)
Levonorgestrel
Intervention Description
Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Intervention Type
Drug
Intervention Name(s)
Anastrozole
Intervention Description
Participants received Anastrozole 300 µg/d or 600 µg/d or 1050 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
Intervention Type
Drug
Intervention Name(s)
Lupron / Leuprolide acetate
Intervention Description
Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Lupron / Leuprolide acetate 11.25 mg 3-months depot intramuscular injection
Primary Outcome Measure Information:
Title
Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to End of Treatment (Last 28 Days of Treatment Period, Days 57-84) as Measured on NRS by Question 1 of ESD
Description
Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain of the 7 days with worst EAPP within a 28-day window was calculated as the sum of ESD item 1 on 7 days with worst EAPP within that 28-day window divided by 7.
Time Frame
Baseline (last 28 days before randomization), end of treatment (Treatment 3) (last 28 days of the treatment period, Day 57-84)
Secondary Outcome Measure Information:
Title
Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment (Day 1-28) and to Second Cycle Under Study Treatment (Day 29-56) as Measured on NRS by Question 1 of ESD
Description
Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain of the 7 days with worst EAPP within a 28-day window was calculated as the sum of ESD item 1 on 7 days with worst EAPP within that 28-day window divided by 7.
Time Frame
Baseline (last 28 days before randomization), first cycle (Treatment 1) (Day 1-28), second cycle (Treatment 2) (Day 29-56)
Title
Absolute Change in Mean Pain From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment(Day1-28), Second Cycle Under Study Treatment(Day29-56),Third Cycle Under Study Treatment (Day57-84) as Measured on NRS by Question1 of ESD
Description
Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain within a 28-day window was calculated as the sum of ESD item 1 within that 28-day window divided by the number with non-missing days within that 28-day window. Here, number of subjects 'n' signifies evaluable subjects for the respective category.
Time Frame
Baseline (last 28 days before randomization), first cycle (Treatment 1) (Day 1-28), second cycle (Treatment 2) (Day 29-56), and third cycle (Treatment 3) (last 28 days of the treatment period, Day 57-84)
Title
Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain Greater Than or Equal to (>=) 7 as Measured on NRS by Question 1 of ESD as Measured on NRS by Question 1 of ESD
Description
Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain >=7 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that 28-day window where item 1 of the ESD was >=7.
Time Frame
Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)
Title
Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain >=7 as Measured on NRS by Question 1 of ESD
Description
Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain >=7 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that 28-day window where item 1 of the ESD was >=7. Here, number of subjects 'n' signifies evaluable subjects for the respective category.
Time Frame
Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)
Title
Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain >=4 as Measured on NRS by Question 1 of ESD
Description
Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain >=4 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that window where Item 1 of the ESD was >=4. Here, number of subjects 'n' signifies evaluable subjects for the respective category.
Time Frame
Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)
Title
Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain >=4 as Measured on NRS by Question 1 of ESD
Description
Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain >=4 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that window where Item 1 of the ESD was >=4. Here, number of subjects 'n' signifies evaluable subjects for the respective category.
Time Frame
Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Premenopausal women18 years and above at the time of screening.
Women with endometriosis confirmed by laparoscopy or laparotomy within the last ten years but not less than 8 weeks before the screening visit In Japan, diagnosis based on imaging (transvaginal ultrasound or MRI) also qualifies for inclusion.
Moderate to severe endometriosis-associated pelvic pain (EAPP) of ≥5 in the last 28 days before screening visit 1 measured on the numeric rating scale (NRS; i.e. 4-week recall period).
At randomization: Adherence to the study procedures during the screening period, at least 24 diary entries of ESD item 1 during the last 28 consecutive days before the randomization visit, and a sum of the available ESD item 1 ('worst pain' on the daily NRS) entries during this period of at least 98 (corresponding to an average score of ≥ 3.5).
Willingness to use only ibuprofen as rescue pain medication for EAPP, if needed according to investigator's instruction.
Use of a non-hormonal barrier method (i.e. spermicide-coated condoms) for contraception from screening visit until the end of the study. This is not required if adequate contraception is achieved by vasectomy of the partner
Exclusion Criteria:
Pregnancy or lactation (less than three months since delivery, abortion, or lactation before start of treatment)
Any diseases or conditions 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.
Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator.
Undiagnosed abnormal genital bleeding
Wish for pregnancy during the study
Regular use of pain medication due to other underlying diseases
Non-responsiveness of endometriosis associated pelvic pain (EAPP) to GnRH-a or surgery (partial response is not exclusionary).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94158-2509
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Palos Heights
State/Province
Illinois
ZIP/Postal Code
60463
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
City
Canton
State/Province
Michigan
ZIP/Postal Code
48187
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07754
Country
United States
City
Plainsboro
State/Province
New Jersey
ZIP/Postal Code
08536
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10038
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
City
Villach
State/Province
Kärnten
ZIP/Postal Code
9500
Country
Austria
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4020
Country
Austria
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
City
Feldkirch
State/Province
Vorarlberg
ZIP/Postal Code
6807
Country
Austria
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Bruxelles - Brussel
ZIP/Postal Code
1000
Country
Belgium
City
Bruxelles - Brussel
ZIP/Postal Code
1070
Country
Belgium
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Liege
ZIP/Postal Code
4000
Country
Belgium
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 7W9
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 2T2
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4P 2S4
Country
Canada
City
Quebec
ZIP/Postal Code
G1S 2L6
Country
Canada
City
Brno
ZIP/Postal Code
602 00
Country
Czechia
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
City
Ceske Budejovice
ZIP/Postal Code
37001
Country
Czechia
City
Hradec Kralove
ZIP/Postal Code
500 03
Country
Czechia
City
Olomouc
ZIP/Postal Code
772 00
Country
Czechia
City
Ostrava
ZIP/Postal Code
700 30
Country
Czechia
City
Pisek
ZIP/Postal Code
39701
Country
Czechia
City
Plzen
ZIP/Postal Code
326 00
Country
Czechia
City
Praha 2
Country
Czechia
City
Praha 7
ZIP/Postal Code
170 00
Country
Czechia
City
Tabor
ZIP/Postal Code
39003
Country
Czechia
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
City
Odense C
ZIP/Postal Code
DK-5000
Country
Denmark
City
Espoo
ZIP/Postal Code
02100
Country
Finland
City
Helsinki
ZIP/Postal Code
00260
Country
Finland
City
Hyvinkää
ZIP/Postal Code
05850
Country
Finland
City
Jyväskylä
ZIP/Postal Code
40100
Country
Finland
City
Kuopio
ZIP/Postal Code
70100
Country
Finland
City
Oulu
ZIP/Postal Code
90100
Country
Finland
City
Turku
ZIP/Postal Code
20520
Country
Finland
City
Turku
ZIP/Postal Code
20540
Country
Finland
City
Esslingen
State/Province
Baden-Württemberg
ZIP/Postal Code
73730
Country
Germany
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
City
Karlsruhe
State/Province
Baden-Württemberg
ZIP/Postal Code
76199
Country
Germany
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
65165
Country
Germany
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
City
Aachen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52074
Country
Germany
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50931
Country
Germany
City
Bernburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06406
Country
Germany
City
Blankenburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
38889
Country
Germany
City
Dippoldiswalde
State/Province
Sachsen
ZIP/Postal Code
01744
Country
Germany
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
City
Jena
State/Province
Thüringen
ZIP/Postal Code
07743
Country
Germany
City
Berlin
ZIP/Postal Code
10787
Country
Germany
City
Berlin
ZIP/Postal Code
12200
Country
Germany
City
Hamburg
ZIP/Postal Code
20357
Country
Germany
City
Hamburg
ZIP/Postal Code
22587
Country
Germany
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
City
Siena
State/Province
Toscana
ZIP/Postal Code
53100
Country
Italy
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
800-0296
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
006-8555
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0031
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0061
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0807
Country
Japan
City
Akashi
State/Province
Hyogo
ZIP/Postal Code
674-0063
Country
Japan
City
Kawanishi
State/Province
Hyogo
ZIP/Postal Code
666-0125
Country
Japan
City
Omitama
State/Province
Ibaraki
ZIP/Postal Code
311-3435
Country
Japan
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8530
Country
Japan
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
210-0852
Country
Japan
City
Kurashiki
State/Province
Okayama
ZIP/Postal Code
710-0824
Country
Japan
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
430-0929
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
City
Minatoku
State/Province
Tokyo
ZIP/Postal Code
107-0052
Country
Japan
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
City
Kumamoto
ZIP/Postal Code
861-8520
Country
Japan
City
Nagano
ZIP/Postal Code
381-8551
Country
Japan
City
Osaka
ZIP/Postal Code
543-0023
Country
Japan
City
Almere
Country
Netherlands
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
City
Asker
ZIP/Postal Code
1383
Country
Norway
City
Stokmarknes
ZIP/Postal Code
8450
Country
Norway
City
Tromsø
ZIP/Postal Code
9019
Country
Norway
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
City
Tønsberg
ZIP/Postal Code
3111
Country
Norway
City
Bialystok
ZIP/Postal Code
15- 224
Country
Poland
City
Katowice
ZIP/Postal Code
40-724
Country
Poland
City
Krakow
ZIP/Postal Code
31-121
Country
Poland
City
Leczna
ZIP/Postal Code
21-010
Country
Poland
City
Lodz
ZIP/Postal Code
90-602
Country
Poland
City
Lublin
ZIP/Postal Code
20-632
Country
Poland
City
Szczecin
ZIP/Postal Code
71-270
Country
Poland
City
Aravaca
State/Province
Madrid
ZIP/Postal Code
28023
Country
Spain
City
Collado Villalba
State/Province
Madrid
ZIP/Postal Code
28400
Country
Spain
City
Pozuelo de Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
City
Valencia
ZIP/Postal Code
46010
Country
Spain
City
Valencia
ZIP/Postal Code
46014
Country
Spain
City
Vitoria
State/Province
Álava
ZIP/Postal Code
01009
Country
Spain
City
Lugano
State/Province
Ticino
ZIP/Postal Code
6900
Country
Switzerland
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
City
Frauenklinik
Country
Switzerland
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Links:
URL
https://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer AG products conducted in Europe.
Learn more about this trial
Bay98-7196, Dose Finding / POC Study
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