Trial Condition(s):

Endometriosis

Bay98-7196, Dose finding / POC study

Bayer Identifier:

15832

ClinicalTrials.gov Identifier:

NCT02203331

EudraCT Number:

2013-005090-53

Study Completed

Trial Purpose

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

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).

Trial Summary

Enrollment Goal
319
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Anastrozole / Levonorgestrel (BAY98-7196)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Clearwater, United States, 33761

Status
Terminated
 
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Investigative Site

Lincoln, United States, 68510

Status
Completed
 
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Investigative Site

Augusta, United States, 30912

Status
Terminated
 
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Plainsboro, United States, 08536

Status
Completed
 
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Miami, United States, 33176

Status
Terminated
 
Locations

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Siena, Italy, 53100

Status
Terminated
 
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Pavia, Italy, 27100

Status
Terminated
 
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Brescia, Italy, 25123

Status
Terminated
 
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Genova, Italy, 16132

Status
Terminated
 
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Barcelona, Spain, 08028

Status
Terminated
 
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Sevilla, Spain, 41014

Status
Completed
 
Locations

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Aravaca, Spain, 28023

Status
Completed
 
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Pozuelo de Alarcón, Spain, 28223

Status
Completed
 
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Copenhagen, Denmark, 2100

Status
Completed
 
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Odense C, Denmark, DK-5000

Status
Completed
 
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Aarhus N, Denmark, 8200

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Completed
 
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Praha 2, Czech Republic

Status
Completed
 
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Pisek, Czech Republic, 39701

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Completed
 
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Ceske Budejovice, Czech Republic, 37001

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Completed
 
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Brno, Czech Republic, 625 00

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Completed
 
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Wien, Austria, 1090

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Completed
 
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Salzburg, Austria, 5020

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Terminated
 
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Linz, Austria, 4020

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Completed
 
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Innsbruck, Austria, 6020

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Completed
 
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Bern, Switzerland, 3010

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Completed
 
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Zürich, Switzerland, 8091

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Terminated
 
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Kuopio, Finland, 70100

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Completed
 
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Turku, Finland, 20520

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Completed
 
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Espoo, Finland, 02100

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Completed
 
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Hyvinkää, Finland, 05850

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Completed
 
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Jyväskylä, Finland, 40100

Status
Completed
 
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Karlsruhe, Germany, 76199

Status
Completed
 
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Dippoldiswalde, Germany, 01744

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Completed
 
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Bernburg, Germany, 06406

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Completed
 
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Köln, Germany, 50931

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Completed
 
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Erlangen, Germany, 91054

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Completed
 
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Hamburg, Germany, 20357

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Completed
 
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Hamburg, Germany, 22587

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Completed
 
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Berlin, Germany, 10787

Status
Completed
 
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BRUXELLES - BRUSSEL, Belgium, 1070

Status
Completed
 
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EDEGEM, Belgium, 2650

Status
Completed
 
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BRUXELLES - BRUSSEL, Belgium, 1000

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Completed
 
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GENT, Belgium, 9000

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Completed
 
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Nieuwegein, Netherlands, 3435 CM

Status
Completed
 
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Trondheim, Norway, 7006

Status
Completed
 
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Stokmarknes, Norway, 8450

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Completed
 
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Tromsø, Norway, 9019

Status
Completed
 
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ZWOLLE, Netherlands, 8025 AB

Status
Completed
 
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GRONINGEN, Netherlands, 9700 RB

Status
Completed
 
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Almere, Netherlands

Status
Completed
 
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Feldkirch, Austria, 6807

Status
Terminated
 
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Investigative Site

Barcelona, Spain, 08036

Status
Completed
 
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Investigative Site

Philadelphia, United States, 19104

Status
Completed
 
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Investigative Site

Canton, United States, 48187

Status
Completed
 
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Neptune, United States, 07754

Status
Completed
 
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Investigative Site

Hamilton, Canada, L8S 4K1

Status
Completed
 
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Quebec, Canada, G1S 2L6

Status
Completed
 
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Montreal, Canada, H4P 2S4

Status
Completed
 
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Toronto, Canada, M5C 2T2

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Completed
 
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Marrero, United States, 70072

Status
Completed
 
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Seattle, United States, 98105

Status
Completed
 
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Investigative Site

San Diego, United States, 92108

Status
Completed
 
Locations

Investigative Site

New York, United States, 10038

Status
Terminated
 
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Villach, Austria, 9500

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08003

Status
Completed
 
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Investigative Site

San Francisco, United States, 94158-2509

Status
Completed
 
Locations

Investigative Site

Torrance, United States, 90505

Status
Terminated
 
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Investigative Site

Sandy Springs, United States, 30328

Status
Completed
 
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Investigative Site

New Haven, United States, 06511

Status
Terminated
 
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Investigative Site

Chattanooga, United States, 37404

Status
Completed
 
Locations

Investigative Site

Leczna, Poland, 21-010

Status
Completed
 
Locations

Investigative Site

Lublin, Poland, 20-632

Status
Completed
 
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Investigative Site

Bialystok, Poland, 15- 224

Status
Completed
 
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Investigative Site

Chicago, United States, 60611

Status
Completed
 
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Investigative Site

Lugano, Switzerland, 6900

Status
Terminated
 
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Investigative Site

Lausanne, Switzerland, 1011

Status
Completed
 
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Investigative Site

Sapporo, Japan, 060-0031

Status
Completed
 
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Investigative Site

Sapporo, Japan, 060-0061

Status
Completed
 
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Investigative Site

Turku, Finland, 20540

Status
Terminated
 
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Investigative Site

Sapporo, Japan, 006-8555

Status
Completed
 
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Investigative Site

Omitama, Japan, 311-3435

Status
Terminated
 
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Investigative Site

Kanazawa, Japan, 920-8530

Status
Completed
 
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Investigative Site

Osakasayama, Japan, 589-8511

Status
Completed
 
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Investigative Site

Kurashiki, Japan, 710-0824

Status
Completed
 
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Kitakyushu, Japan, 800-0296

Status
Completed
 
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Tønsberg, Norway, 3111

Status
Completed
 
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Investigative Site

Kawasaki, Japan, 210-0852

Status
Terminated
 
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Investigative Site

Minatoku, Japan, 107-0052

Status
Completed
 
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Investigative Site

Bunkyo-ku, Japan, 113-8431

Status
Completed
 
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Investigative Site

Hamamatsu, Japan, 430-0929

Status
Completed
 
Locations

Investigative Site

Shinagawa-ku, Japan, 141-8625

Status
Completed
 
Locations

Investigative Site

Sapporo, Japan, 060-0807

Status
Completed
 
Locations

Investigative Site

Osaka, Japan, 543-0023

Status
Completed
 
Locations

Investigative Site

Olomouc, Czech Republic, 772 00

Status
Completed
 
Locations

Investigative Site

Brno, Czech Republic, 602 00

Status
Completed
 
Locations

Investigative Site

Helsinki, Finland, 00260

Status
Completed
 
Locations

Investigative Site

Kumamoto, Japan, 861-8520

Status
Completed
 
Locations

Investigative Site

Akashi, Japan, 674-0063

Status
Terminated
 
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Investigative Site

Luzern, Switzerland, 6000

Status
Completed
 
Locations

Investigative Site

New Port Richey, United States, 34652

Status
Completed
 
Locations

Investigative Site

Frauenklinik, Switzerland

Status
Completed
 
Locations

Investigative Site

Kawanishi, Japan, 666-0125

Status
Completed
 
Locations

Investigative Site

Dayton, United States, 45409

Status
Completed
 
Locations

Investigative Site

Nagano, Japan, 381-8551

Status
Completed
 
Locations

Investigative Site

Berlin, Germany, 12200

Status
Completed
 
Locations

Investigative Site

Dresden, Germany, 01307

Status
Completed
 
Locations

Investigative Site

Ottawa, Canada, K1H 7W9

Status
Completed
 
Locations

Investigative Site

Jena, Germany, 07743

Status
Completed
 
Locations

Investigative Site

Blankenburg, Germany, 38889

Status
Completed
 
Locations

Investigative Site

Lodz, Poland, 90-602

Status
Completed
 
Locations

Investigative Site

Asker, Norway, 1383

Status
Completed
 
Locations

Investigative Site

Oulu, Finland, 90100

Status
Completed
 
Locations

Investigative Site

Valencia, Spain, 46010

Status
Completed
 
Locations

Investigative Site

Valencia, Spain, 46014

Status
Completed
 
Locations

Investigative Site

Collado Villalba, Spain, 28400

Status
Completed
 
Locations

Investigative Site

Vitoria, Spain, 01009

Status
Completed
 
Locations

Investigative Site

Palos Heights, United States, 60463

Status
Completed
 
Locations

Investigative Site

Atlanta, United States, 30328

Status
Terminated
 
Locations

Investigative Site

Durham, United States, 27713

Status
Completed
 
Locations

Investigative Site

Columbus, United States, 43213

Status
Completed
 
Locations

Investigative Site

Wichita, United States, 67226

Status
Completed
 
Locations

Investigative Site

Madison, United States, 53562

Status
Completed
 
Locations

Investigative Site

Atlanta, United States, 30338

Status
Completed
 
Locations

Investigative Site

Mannheim, Germany, 65165

Status
Completed
 
Locations

Investigative Site

München, Germany, 81675

Status
Completed
 
Locations

Investigative Site

Fort Myer, United States, 33907

Status
Terminated
 
Locations

Investigative Site

Saginaw, United States, 48604

Status
Completed
 
Locations

Investigative Site

LIEGE, Belgium, 4000

Status
Terminated
 
Locations

Investigative Site

Hradec Kralove, Czech Republic, 500 03

Status
Completed
 
Locations

Investigative Site

Tabor, Czech Republic, 39003

Status
Completed
 
Locations

Investigative Site

Hannover, Germany, 30625

Status
Terminated
 
Locations

Investigative Site

Winston-Salem, United States, 27103

Status
Completed
 
Locations

Investigative Site

Plzen, Czech Republic, 326 00

Status
Completed
 
Locations

Investigative Site

Aachen, Germany, 52074

Status
Completed
 
Locations

Investigative Site

Szczecin, Poland, 71-270

Status
Completed
 
Locations

Investigative Site

Krakow, Poland, 31-121

Status
Completed
 
Locations

Investigative Site

Katowice, Poland, 40-724

Status
Completed
 
Locations

Investigative Site

Detroit, United States, 48034

Status
Completed
 
Locations

Investigative Site

Greensboro, United States, 27408

Status
Completed
 
Locations

Investigative Site

Gainesville, United States, 32605

Status
Completed
 
Locations

Investigative Site

Ostrava, Czech Republic, 700 30

Status
Terminated
 
Locations

Investigative Site

Esslingen, Germany, 73730

Status
Terminated
 
Locations

Investigative Site

Praha 7, Czech Republic, 170 00

Status
Terminated
 
Locations

Investigative Site

Heidelberg, Germany, 69120

Status
Terminated
 

Trial Design