check_circleStudy Completed
Endometriosis
Bayer Identifier:
15832
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Bay98-7196, Dose finding / POC study
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
Key Participants Requirements
Sex
FemaleAge
18 - N/ATrial summary
Enrollment Goal
319Trial Dates
October 2014 - October 2016Phase
Phase 2Could I Receive a placebo
YesProducts
Anastrozole and Levonorgestrel (BAY98-7196)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Withdrawn | Clearwater, 33761, United States | |
Completed | Lincoln, 68510, United States | |
Withdrawn | Augusta, 30912, United States | |
Completed | Plainsboro, 08536, United States | |
Withdrawn | Miami, 33176, United States | |
Withdrawn | Siena, 53100, Italy | |
Withdrawn | Pavia, 27100, Italy | |
Withdrawn | Brescia, 25123, Italy | |
Withdrawn | Genova, 16132, Italy | |
Completed | Sevilla, 41014, Spain | |
Completed | Aravaca, 28023, Spain | |
Completed | Pozuelo de Alarcón, 28223, Spain | |
Completed | Copenhagen, 2100, Denmark | |
Completed | Odense C, DK-5000, Denmark | |
Completed | Aarhus N, 8200, Denmark | |
Completed | Praha 2, Czechia | |
Completed | Pisek, 39701, Czechia | |
Completed | Ceske Budejovice, 37001, Czechia | |
Completed | Brno, 625 00, Czechia | |
Completed | Wien, 1090, Austria | |
Withdrawn | Salzburg, 5020, Austria | |
Completed | Linz, 4020, Austria | |
Completed | Innsbruck, 6020, Austria | |
Completed | Bern, 3010, Switzerland | |
Withdrawn | Zürich, 8091, Switzerland | |
Completed | Kuopio, 70100, Finland | |
Completed | Turku, 20520, Finland | |
Completed | Espoo, 02100, Finland | |
Completed | Hyvinkää, 05850, Finland | |
Completed | Jyväskylä, 40100, Finland | |
Completed | Karlsruhe, 76199, Germany | |
Completed | Dippoldiswalde, 01744, Germany | |
Completed | Bernburg, 06406, Germany | |
Completed | Köln, 50931, Germany | |
Completed | Erlangen, 91054, Germany | |
Completed | Hamburg, 20357, Germany | |
Completed | Hamburg, 22587, Germany | |
Completed | Berlin, 10787, Germany | |
Completed | BRUXELLES - BRUSSEL, 1070, Belgium | |
Completed | EDEGEM, 2650, Belgium | |
Completed | BRUXELLES - BRUSSEL, 1000, Belgium | |
Completed | GENT, 9000, Belgium | |
Completed | Nieuwegein, 3435 CM, Netherlands | |
Completed | Trondheim, 7006, Norway | |
Completed | Stokmarknes, 8450, Norway | |
Completed | Tromsø, 9019, Norway | |
Completed | ZWOLLE, 8025 AB, Netherlands | |
Completed | GRONINGEN, 9700 RB, Netherlands | |
Completed | Almere, Netherlands | |
Withdrawn | Feldkirch, 6807, Austria | |
Completed | Barcelona, 8036, Spain | |
Completed | Philadelphia, 19104, United States | |
Completed | Canton, 48187, United States | |
Completed | Neptune, 07754, United States | |
Completed | Hamilton, L8S 4K1, Canada | |
Completed | Quebec, G1S 2L6, Canada | |
Completed | Montreal, H4P 2S4, Canada | |
Completed | Toronto, M5C 2T2, Canada | |
Completed | Marrero, 70072, United States | |
Completed | Seattle, 98105, United States | |
Completed | San Diego, 92108, United States | |
Withdrawn | New York, 10038, United States | |
Completed | Villach, 9500, Austria | |
Completed | Barcelona, 08003, Spain | |
Completed | San Francisco, 94158-2509, United States | |
Withdrawn | Torrance, 90505, United States | |
Completed | Sandy Springs, 30328, United States | |
Withdrawn | New Haven, 06511, United States | |
Completed | Chattanooga, 37404, United States | |
Completed | Leczna, 21-010, Poland | |
Completed | Lublin, 20-632, Poland | |
Completed | Bialystok, 15- 224, Poland | |
Completed | Chicago, 60611, United States | |
Withdrawn | Lugano, 6900, Switzerland | |
Completed | Lausanne, 1011, Switzerland | |
Completed | Sapporo, 060-0031, Japan | |
Completed | Sapporo, 060-0061, Japan | |
Withdrawn | Turku, 20540, Finland | |
Completed | Sapporo, 006-8555, Japan | |
Withdrawn | Omitama, 311-3435, Japan | |
Completed | Kanazawa, 920-8530, Japan | |
Completed | Osakasayama, 589-8511, Japan | |
Completed | Kurashiki, 710-0824, Japan | |
Completed | Kitakyushu, 800-0296, Japan | |
Completed | Tønsberg, 3111, Norway | |
Withdrawn | Kawasaki, 210-0852, Japan | |
Completed | Minatoku, 107-0052, Japan | |
Completed | Bunkyo-ku, 113-8431, Japan | |
Completed | Hamamatsu, 430-0929, Japan | |
Completed | Shinagawa-ku, 141-8625, Japan | |
Completed | Sapporo, 060-0807, Japan | |
Completed | Osaka, 543-0023, Japan | |
Completed | Olomouc, 772 00, Czechia | |
Completed | Brno, 602 00, Czechia | |
Completed | Helsinki, 00510, Finland | |
Completed | Kumamoto, 861-8520, Japan | |
Withdrawn | Akashi, 674-0063, Japan | |
Completed | Luzern, 6000, Switzerland | |
Completed | New Port Richey, 34652, United States | |
Completed | Frauenklinik, Switzerland | |
Completed | Kawanishi, 666-0125, Japan | |
Completed | Dayton, 45409, United States | |
Completed | Nagano, 381-8551, Japan | |
Completed | Berlin, 12200, Germany | |
Completed | Dresden, 01307, Germany | |
Completed | Ottawa, K1H 7W9, Canada | |
Completed | Jena, 07743, Germany | |
Completed | Blankenburg, 38889, Germany | |
Completed | Lodz, 90-602, Poland | |
Completed | Asker, 1383, Norway | |
Completed | Oulu, 90100, Finland | |
Completed | Valencia, 46010, Spain | |
Completed | Valencia, 46014, Spain | |
Completed | Collado Villalba, 28400, Spain | |
Completed | Vitoria, 01009, Spain | |
Completed | Palos Heights, 60463, United States | |
Withdrawn | Atlanta, 30328, United States | |
Completed | Durham, 27713, United States | |
Completed | Columbus, 43213, United States | |
Completed | Wichita, 67226, United States | |
Completed | Madison, 53562, United States | |
Completed | Atlanta, 30338, United States | |
Completed | Mannheim, 68165, Germany | |
Completed | München, 81675, Germany | |
Withdrawn | Fort Myer, 33907, United States | |
Completed | Saginaw, 48604, United States | |
Withdrawn | Liege, 4000, Belgium | |
Completed | Hradec Kralove, 500 03, Czechia | |
Completed | Tabor, 39003, Czechia | |
Withdrawn | Hannover, 30625, Germany | |
Completed | Winston-Salem, 27103, United States | |
Completed | Plzen, 326 00, Czechia | |
Completed | Aachen, 52074, Germany | |
Completed | Szczecin, 71-434, Poland | |
Completed | Krakow, 31-121, Poland | |
Completed | Katowice, 40-724, Poland | |
Completed | Detroit, 48034, United States | |
Completed | Greensboro, 27408, United States | |
Completed | Gainesville, 32605, United States | |
Withdrawn | Ostrava, 700 30, Czechia | |
Withdrawn | Esslingen, 73730, Germany | |
Withdrawn | Praha 7, 170 00, Czechia | |
Withdrawn | Heidelberg, 69120, Germany |
Primary Outcome
- Absolute change in mean pain of the 7 days with worst endometriosis associated pelvic pain (EAPP) from baseline (last 28 days before randomization) to end of treatment (last 28 days of the treatment period).date_rangeTime Frame:baseline (last 28 days before randomization) versus end of treatment (last 28 days of the treatment period, Day 57 - 84)enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Absolute change in mean pain of the 7 days with worst endometriosis associated pelvic pain (EAPP) from baseline (last 28 days before randomization) to the first cycle under study treatment (Day 1 - 28) and to the second cycle under study treatment.date_rangeTime Frame:baseline (last 28 days before randomization) vs the first cycle under study treatment (Day 1 - 28) and vs the second cycle under study treatment (Day 29 - 56)enhanced_encryptionNoSafety Issue:
- Absolute change in mean pain from baseline (last 28 days before randomization) to the first cycle under study treatment (Day 1 - 28), the second cycle under study treatment (Day 29 - 56), and to the third cycle under study treatment (Day 57 - 84)date_rangeTime Frame:baseline (last 28 days before randomization) vs the first cycle under study treatment (Day 1 - 28), the second cycle under study treatment (Day 29 - 56), and the third cycle under study treatment (Day 57 - 84)enhanced_encryptionNoSafety Issue:
- Number of days during baseline (last 28 days before randomization) and Cycles 1, 2, and 3 with pain ≥ 7 (measured on the NRS by Question 1 of the ESD)date_rangeTime Frame:baseline (last 28 days before randomization) and Cycles 1, 2, and 3enhanced_encryptionNoSafety Issue:
- Change of days from baseline (last 28 days before randomization) and Cycles 1, 2, and 3 with pain ≥ 7 (measured on the NRS by Question 1 of the ESD)date_rangeTime Frame:baseline (last 28 days before randomization) and Cycles 1, 2, and 3enhanced_encryptionNoSafety Issue:
- Number of days during baseline (last 28 days before randomization) and Cycles 1, 2, and 3 with pain ≥ 4 (measured on the NRS by Question 1 of the ESD)date_rangeTime Frame:baseline (last 28 days before randomization) and Cycles 1, 2, and 3enhanced_encryptionNoSafety Issue:
- Change of days from baseline (last 28 days before randomization) and Cycles 1, 2, and 3 with pain ≥ 4 (measured on the NRS by Question 1 of the ESD)date_rangeTime Frame:baseline (last 28 days before randomization) and Cycles 1, 2, and 3enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
6Additional Information
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